Preoperative interventions for reducing anxiety in school‐age children undergoing surgery: a network meta‐analysis

Objectives

This is a protocol for a Cochrane Review (intervention). The objectives are as follows:

To compare the benefits and harms of pharmacological and non‐pharmacological preoperative interventions (alone or in combination) for reducing anxiety in school‐age children undergoing elective surgery under general anaesthesia, and to rank the interventions according to their efficacy and safety.

Background

Description of the condition

Each year, millions of children worldwide undergo surgical procedures, ranging from routine elective operations such as tonsillectomy, adenoidectomy, and hernia repair to more complex interventions [1]. The perioperative period represents a significant source of distress, with estimates suggesting that 42% to 75% of children experience clinically significant preoperative anxiety prior to induction of anaesthesia [2, 3, 4, 5, 6, 7]. The focus of this review is children undergoing elective procedures performed under general anaesthesia, as emergency surgery, dental procedures, and interventions conducted solely under sedation or local anaesthesia differ substantially in their timing, predictability, clinical urgency, physiological stress burden, and opportunity for standardised preoperative preparation, all of which directly influence the feasibility and design of anxiety‐reducing interventions.

Preoperative anxiety can have both immediate and longer‐term consequences, including increased perioperative distress, poor cooperation during induction, emergence delirium, maladaptive postoperative behaviour (such as sleep disturbance or separation anxiety), heightened postoperative pain, greater analgesic requirements, prolonged recovery, and reduced satisfaction for both patients and parents [3, 8, 9, 10, 11, 12, 13]. Physiologically, anxious children often exhibit tachycardia, hypertension, and raised cortisol levels, all of which can complicate anaesthetic management and recovery [2]. In some cases, preoperative anxiety may also contribute to the development of chronic anxiety disorders or phobias associated with medical settings in later life.

Multiple factors can influence a child's anxiety level before surgery. Younger age, certain temperamental traits (e.g. high emotionality or low adaptability), limited prior healthcare exposure, and previous negative or painful medical experiences have been identified as risk factors for heightened preoperative anxiety. Parental anxiety can also transfer to the child, compounding the child’s distress and behavioural resistance. The period immediately before induction of anaesthesia – particularly during mask application or separation from parents – is often the most stressful time for the child. If inadequately managed, this anxiety can lead to increased anaesthetic requirements, greater postoperative pain perception, and diminished overall perioperative satisfaction.

The school‐age period (6 to 12 years) represents a distinct developmental phase: children in this age range possess growing cognitive capacity to understand and anticipate surgery and future events, yet their emotional regulation and coping strategies remain incompletely developed [3, 14]. Consequently, they experience both cognitive anticipation and emotional arousal, but lack the mature mechanisms to modulate fear and uncertainty. These developmental features make them particularly vulnerable to preoperative anxiety and highlight the need for age‐appropriate, tailored interventions, which differ from those effective in toddlers, adolescents, or adults.

The assessment of preoperative anxiety in this age group relies on instruments validated for school‐age children, including the modified Yale Preoperative Anxiety Scale (mYPAS), which uses directly observable behavioural cues, such as activity level, vocalisation, emotional expressiveness, state of apparent arousal, and use of parents [15]. These are scored by a trained observer at defined perioperative time points. Because these instruments presume typical developmental communication abilities and predictable behavioural repertoires, their validity may be compromised in children with severe intellectual or neurodevelopmental disorders, whose atypical behavioural responses may not be reliably captured by standard scoring algorithms.

Responsibility for managing preoperative anxiety typically falls to the perioperative nursing and anaesthesia team, although the degree of involvement of other professionals — such as child life specialists, play therapists, or psychologists — varies considerably across settings and healthcare systems. In many institutions, standard care consists of verbal reassurance and parental presence in the preoperative area, with pharmacological premedication used selectively [16]. The absence of a consistent, evidence‐based approach to preoperative anxiety management in routine clinical practice underscores the need for a comprehensive synthesis of comparative evidence, as provided by this review.

Description of the intervention and how it might work

A wide range of pharmacological and non‐pharmacological interventions have been used to reduce preoperative anxiety in children, which target different physiological or psychological pathways of anxiety [17, 18, 19, 20]. Pharmacological interventions reduce anxiety by modulating neurotransmitter systems that regulate fear, arousal, and stress (including GABAergic, noradrenergic, NMDA, and melatonergic pathways). Non‐pharmacological interventions act primarily through mechanisms such as cognitive‐affective processing (e.g. guided imagery), anticipatory threat appraisal and attentional disengagement from aversive stimuli (e.g. distraction techniques), and fostering of parental co‐regulation. Both categories of intervention ultimately decrease activation of the hypothalamic‐pituitary‐adrenal (HPA) axis, dampen autonomic arousal, and reduce behavioural distress responses [2, 21].

In addition to the detail below, we present a summary of the pharmacological and non‐pharmacological interventions available for preoperative anxiety reduction in school‐age children in Table 1 and Table 2.

1. Preoperative interventions for reducing anxiety in children of school age undergoing surgery: non‐pharmacological.

Intervention category	Intervention	Intervention description	Mechanism of action	Recommended timing before induction of anaesthesia	Implementation considerations and potential adverse effects
Educational interventions	Educational/preparation programmes [61, 149]	Age‐appropriate information about anaesthesia, surgical pathway, and hospital environment, delivered by healthcare providers or child‐life specialists	Reduces uncertainty, enhances predictability, and fosters a sense of control, lowering anticipatory anxiety through cognitive reappraisal	10 to 30 min 1 to 2 days pre‐induction	‐ May not suit children with very high baseline anxiety ‐ Requires parental engagement and staff/resources
	Preoperative videos [150, 151, 152, 153]	Age‐appropriate animated or informational clips explaining the surgical process; includes VR‐delivered cartoon videos	Visual familiarity reduces fear of the unknown	10 to 15 min 1 to 2 days pre‐induction	‐ If too graphic, may elicit questions ‐ Developmental appropriateness should be considered
	Printed and digital materials [154]	Leaflets, booklets, e‐books (including interactive: lift‐the‐flap, pop‐ups)	Structured information builds familiarity and reduces uncertainty	10 to 15 min 1 to 2 days pre‐induction	‐ May require parental assistance for younger children ‐ Availability of materials should be confirmed ‐ Interactive digital formats may improve engagement over static print
	Hospital/operating theatre tour [155, 156]	Guided visit to waiting areas, anaesthesia room and operating theatre prior to surgery	Reduces fear of the unknown by experiential familiarisation	30 min 1 to 3 days pre‐induction	‐ Possible initial anxiety until familiarisation ‐ Requires coordination with clinical team ‐ May be partially replaced by VR‐based virtual tours in resource‐constrained settings
	Web‐based or mobile applications [16, 157, 158, 159]	Interactive online or app‐based educational tools (e.g. animated games, interactive hospital tours, coping‐skills training); includes AI‐generated content for personalised interventions	Familiarises children with the surgical process, increases child engagement and sense of agency; combines preparation with active distraction	10 to 30 min 1 to 3 days pre‐induction	‐ Requires device and internet access ‐ Engagement may vary by age and parental involvement ‐ Limited effect without supervision or reinforcement
	Virtual reality (educational) [78, 80, 83, 84, 160, 161]	Immersive VR walkthroughs of the perioperative pathway (operating theatre tour, anaesthesia simulation, procedural familiarisation)	Familiarisation reduces fear of the unknown through cognitive remodelling; engages the prefrontal cortex, modulates pain pathways, and reduces anxiety‐related activity in thalamus, insula, and anterior cingulate cortex	10 to 20 min ≤ 1 h pre‐induction (optimal) 1 to 2 days pre‐induction also effective	‐ Possible transient dizziness or nausea ‐ Needs VR equipment and supervision, and infection‐control protocols between uses ‐ Feasibility barriers include organisational coordination, workflow interruptions, and need for institutional policy
	Augmented reality (AR) [162, 163]	Overlay of animated virtual characters and relaxation‐technique guidance on the real environment via tablet or AR glasses; child maintains visual contact with surroundings	Combines cognitive distraction with real‐world familiarisation; maintains situational awareness during induction, unlike fully immersive VR	20 to 30 min pre‐induction	‐ Requires dedicated device and content development
Relaxation & cognitive‐behavioural techniques	Guided imagery & relaxation training [57, 58]	Therapist‐led or audio‐recorded visualisations and breathing/muscular relaxation	Reduces sympathetic activation, lowers heart rate/blood pressure, engages parasympathetic pathways	15 to 20 min pre‐induction	‐ Possible initial restlessness or difficulty concentrating ‐ Requires skilled facilitator
	Cognitive‐behavioural (CBT)–based coping skills teaching [61, 62]	Teaches children to identify/reframe anxious thoughts, use positive self‐talk, and develop coping strategies	Enhances emotional regulation and reduces anticipatory anxiety through cognitive restructuring	30 to 45 min 1 to 2 days pre‐induction	‐ Possible transient frustration or emotional discomfort ‐ Requires trained clinician and scheduling
	Clinical hypnotherapy [63, 64]	Professionally delivered suggestions to induce deep relaxation and positive coping imagery	Alters consciousness and promotes dissociation from stressors	20 to 30 min pre‐induction	‐ Rare: lightheadedness or drowsiness ‐ Requires certified hypnotherapist
	Breathing exercises/mindfulness [59, 60]	Child‐friendly mindfulness (e.g. 5‐senses grounding, diaphragmatic breathing)	Fosters present‐moment focus, promotes attentional regulation and metacognitive awareness, activates parasympathetic system, slows physiological arousal	5 to 10 min pre‐induction	‐ Generally none — some children may feel dizziness if hyperventilating
	Peer‐modelling [154]	Watching videos or meeting older children with calm perioperative experiences	Normalises process and reduces fear of isolation through social learning	10 to 15 min pre‐induction	‐ Logistics may be challenging if volunteer scheduling is tight
	Therapeutic storytelling/ narrative therapy [164, 165]	Use of storybooks or puppet play to normalise surgical experience and model calm coping	Facilitates emotional processing through narrative engagement	10 to 15 min pre‐induction	‐ Age‐appropriateness of stories should be considered ‐ May prompt additional questions
Distraction techniques	Virtual reality [8, 45]	Immersive non‐educational VR scenarios (games/playful environments, underwater or space themes)	Reduces subjective and observable distress through cognitive diversion; engages prefrontal cortex, influences pain pathways, and reduces pain‐related activity in thalamus, insula, anterior cingulate cortex, and primary/secondary somatosensory cortices	5 to 15 min pre‐induction (optimal timing is immediately before or during operating theatre entry)	‐ Possible transient dizziness or nausea ‐ Minor technical issues ‐ Requires infection‐control protocols (goggles disinfection)
	Interactive distraction (handheld video games/tablets) [79, 85, 151, 166, 167, 168]	Video games or apps engage visual and cognitive attention on handheld device	Diverts focus from anxiety‐provoking stimuli and reduces sympathetic arousal; the interactivity of games promotes sense of agency and control	10 to 15 min pre‐induction	‐ Potential restlessness ‐ Screen fatigue
	Audiovisual distraction [81, 169, 170]	Viewing age‐appropriate videos, cartoons, or films on screen or tablet	Reduces distress through attentional diversion (passive distraction mechanism)	10 to 15 min pre‐induction	‐ May induce drowsiness ‐ Requires audiovisual setup
	Interactive preparatory apps/serious games [171]	Smartphone/tablet apps that educate about surgery, engage coping‐skill practice, and/or provide distraction tasks	Increases child engagement and sense of agency	20 to 30 min 1 to 2 days pre‐induction	‐ Requires device access ‐ May not engage all children equally
Complementary therapies	Music therapy (recorded [70, 71]	Listening to pre‐recorded music selected by child, therapist, or caregiver; may be delivered via headphones, portable speakers, or integrated within VR environments	Modulates limbic system, reduces sympathetic activity, and induces relaxation; child‐selected music may enhance engagement and sense of control	15 to 20 min pre‐induction	‐ Rare: restlessness if unfamiliar music ‐ Minimal sedation
	Massage therapy [69]	Therapeutic manual manipulation of soft tissues	Promotes relaxation, reduces muscle tension, and decreases stress hormones	10 to 15 min pre‐induction	‐ Some children may feel ticklish or uncomfortable, so ensure therapist is trained in paediatric technique
	Acupuncture/acupressure [172, 173]	Acupuncture: insertion of fine needles at specific points Acupressure: non‐invasive pressure on acupoints (e.g. PC6 Neiguan) Auriculotherapy: ear acupoint stimulation	Elicits relaxation via endorphin release and autonomic balance	20 to 30 min pre‐induction	‐ Rare: minor bleeding or bruising ‐ Risk of anxiety if child is afraid of needles, so ensure practitioner is certified
	Aromatherapy [65, 66]	Inhalation of essential oils (e.g. lavender, chamomile) via diffuser or cotton pad	Modulates limbic system, reduces sympathetic arousal, and promotes relaxation	10 min pre‐induction	‐ Rare: allergic reactions, so ensure oils are properly diluted and tested beforehand, and verify no interactions with anaesthetic agents
	Animal‐assisted therapy (AAT) [67, 68]	Interaction with a certified therapy animal (usually a dog) in the preoperative area	Releases oxytocin, reduces cortisol, and lowers anxiety through positive social bonding	10 to 15 min pre‐induction	‐ Possible mild allergic reaction, so ensure child has no pet phobia or allergies ‐ Hospital infection‐control protocols must be respected ‐ Requires certified animal and handler ‐ Scheduling logistics may be challenging
	Live music therapy (music therapist‐led) [174]	Personalised live musical interaction by a certified music therapist, including singing, instrument play, and improvisation	Active engagement with live music enhances emotional co‐regulation; therapist adapts in real time to child’s emotional state	15 to 20 min pre‐induction	‐ Distinguished from recorded music by the personalised, interactive nature of live sessions
Environmental modifications	Child‐friendly preop area (decor, toys, lighting) [73, 74]	Colourful, welcoming environment with cartoon themes, interactive toys, multimedia TVs, soothing lighting, and reduced noise; sensory‐integrated design	Decreases sensory overstimulation and lowers ambient arousal levels; promotes sense of safety and normality	N/A (continuous)	‐ Minimal risk ‐ Requires resource investment and maintenance
	Ambient music & lighting [175]	Soft background music and gentle, warm‐toned lighting create a calming sensory environment in the preoperative/induction area	Reduces sympathetic arousal and modulates ambient sensory input	N/A (continuous)	‐ Needs monitoring to avoid overstimulation or conflict with clinical alarms
	Dimmed lighting/noise reduction [2, 72]	Lowering brightness levels and reducing loud sounds in induction area	Diminishes sensory stressors and promotes relaxation	N/A (continuous)	‐ May conflict with staff visibility requirements, so ensure safety is not compromised
Parental involvement interventions	Parental presence during induction (PPIA) [51, 52, 53, 54, 55, 56]	Trusted caregiver remains with child until anaesthetic mask applied or IV induction completed	Lowers separation anxiety and provides emotional support — but only when the caregiver is calm and adequately prepared	At induction	‐ Efficacy depends critically on parental anxiety level and preparation ‐ Consider screening parental anxiety before recommending PPIA ‐ Some children become more anxious if parent visibly distressed
	Parental coaching & communication sessions [61, 176]	Structured sessions led by healthcare providers teaching parents evidence‐based strategies (calming techniques, coping modelling)	Reduces parental anxiety and indirectly lowers child's anxiety through improved parental co‐regulation	20 to 30 min pre‐induction	‐ Dependent on parent engagement level ‐ Generally well tolerated
	Structured parental support programmes [16, 177, 178]	Preoperative and perioperative coaching and psychological support for parents, including information sessions and emotional support	Improves parental coping and preparedness, thereby reducing child anxiety through the anxiety‐contagion pathway	1 to 2 days pre‐induction	‐ Requires scheduling ‐ Parental availability and willingness
Therapeutic play & creative‐arts approaches	Therapeutic play (medical dolls, role play) [48, 50]	Children use dolls or safe medical equipment to reenact procedures in a supported, playful context	Builds mastery, promotes emotional expression, and provides desensitisation	20 to 30 min pre‐induction	‐ May temporarily increase anxiety if child focuses on negative aspects ‐ Requires CLS and materials
	Art therapy [179, 180, 181]	Therapist‐led creative activities (painting, modelling, storytelling) tailored to child’s developmental stage	Facilitates emotional expression and reduces anxiety through creative outlet	20 to 30 min pre‐induction	‐ Rare: frustration if child feels unable to create ‐ Requires art therapist and materials
	Clown therapy (medical clowns) [182]	Humorous interaction by trained medical clown performers in the preoperative area and during transfer to operating theatre	Elevates mood, distracts attention, and releases endorphins to reduce distress	15 to 20 min pre‐induction	‐ Rare: overstimulation if child is shy or introverted

AAT: animal‐assisted therapy; AR: augmented reality; CBT: cognitive‐behavioural therapy; CLS: child life specialist; IM: intramuscular; IN: intranasal; IV: intravenous; min: minutes; N/A: not applicable; PO: oral (per os); PPIA: parental presence during induction of anaesthesia; PR: rectal (per rectum); preop: preoperative; SL: sublingual; VR: virtual reality

2. Preoperative interventions for reducing anxiety in children of school age undergoing surgery: pharmacological.

Pharmacological class	Intervention	Route	Mechanism of action	Dose	Recommended timing before induction of anaesthesia	Potential adverse effects
Benzodiazepine	Midazolam [22, 24, 147]	PO	Potentiates GABAergic (GABAA) inhibition — rapid anxiolysis, sedation, anterograde amnesia; reduces procedural distress and separation anxiety	0.25 to 1.0 mg/kg (max 20 mg)	20 to 30 min pre‐induction	‐ Transient respiratory depression ‐ Paradoxical agitation ‐ Drowsiness ‐ Dry mouth
		IN	Same mechanism as PO; intranasal route for faster absorption	0.2 to 0.5 mg/kg (max 10 mg)	15 min pre‐induction	‐ Nasal irritation ‐ Transient respiratory depression ‐ Paradoxical agitation ‐ Sedation
		IV	Same mechanism as PO; intravenous route for very rapid onset	0.05 to 0.1 mg/kg (max 5 mg)	10 min pre‐induction	‐ Transient respiratory depression ‐ Paradoxical agitation ‐ Drowsiness ‐ Hypotension
		PR	Same mechanism as PO; rectal mucosal absorption provides a moderate onset of anxiolysis (10 to 15 minutes)	0.3 to 1.0 mg/kg (max 20 mg)	15 to 20 min pre‐induction	‐ Possible mild rectal irritation ‐ Transient respiratory depression ‐ Paradoxical agitation ‐ Drowsiness
	Lorazepam [148]	PO	Potentiates GABAergic inhibition — sedation and anxiolysis	0.05 to 0.1 mg/kg (max 4 mg)	60 min pre‐induction	‐ Drowsiness ‐ Dizziness ‐ Ataxia ‐ Paradoxical agitation ‐ Dry mouth
		IV	Same mechanism as PO; intravenous route for faster onset	0.05 mg/kg (max 2 to 4 mg)	20 min pre‐induction	‐ Respiratory depression ‐ Sedation ‐ Hypotension ‐ Paradoxical reactions
α2‐adrenoceptor agonist	Clonidine [24, 29]	PO	Inhibits noradrenaline release via presynaptic α2‐adrenoceptors — sedation, anxiolysis, and analgesia with minimal respiratory depression	4 µg/kg (max 150 to 200 µg)	60 to 90 min pre‐induction	‐ Hypotension ‐ Bradycardia ‐ Dry mouth ‐ Sedation
		IN	Same mechanism as PO; intranasal route for faster absorption	4 µg/kg (max 200 µg)	45 min pre‐induction	‐ Nasal irritation ‐ Hypotension ‐ Dry mouth ‐ Sedation
		IV	Same mechanism as PO; intravenous route for rapid onset	1 to 3 µg/kg (max 150 µg)	15 min pre‐induction	‐ Hypotension ‐ Bradycardia ‐ Sedation
		SL	Same mechanism as PO; sublingual route for intermediate onset	1 to 4 µg/kg	45 min pre‐induction	‐ Hypotension ‐ Bradycardia ‐ Dry mouth ‐ Sedation
	Dexmedetomidine [22, 23, 30, 31, 32, 33, 34, 35]	PO	Inhibits noradrenaline release via presynaptic α2‐adrenoceptors — sedation, anxiolysis, and mild analgesia with minimal respiratory depression	2.5 to 4 µg/kg	60 min pre‐induction	‐ Hypotension ‐ Bradycardia ‐ Sedation ‐ Delayed emergence
		IN	Same mechanism as PO; intranasal route for non‐invasive administration	1 to 2 µg/kg (premed) 2 to 3 µg/kg (sedation)	45 min pre‐induction	‐ Nasal irritation ‐ Hypotension ‐ Bradycardia ‐ Sedation
		IV	Same mechanism as PO; intravenous route for rapid onset	0.5 to 1 µg/kg	10 min pre‐induction	‐ Bradycardia ‐ Hypotension ‐ Dry mouth ‐ Delayed emergence
		SL	Same mechanism as PO; sublingual route for moderate onset	1 to 2 µg/kg	45 min pre‐induction	‐ Hypotension ‐ Bradycardia ‐ Sedation
Melatonergic agent	Melatonin [37, 38, 39, 40]	PO	Activates MT1/MT2 receptors — modulates circadian rhythms and enhances GABAergic tone — mild sedation and anxiolysis with minimal cognitive impairment	0.2 to 0.75 mg/kg (max 10 to 20 mg)	60 to 90 min pre‐induction	‐ Daytime drowsiness ‐ Headache ‐ Nausea ‐ Dizziness
		SL	Same mechanism as PO; sublingual route for faster onset	0.5 mg/kg	40 min pre‐induction	‐ Headache ‐ Dizziness ‐ Mild sedation
NMDA antagonist	Ketamine [41, 42, 43]	PO	Antagonises NMDA receptors — dampens glutamatergic excitation and stress pathways; subanaesthetic doses provide anxiolysis and analgesia without full unconsciousness.	3 to 10 mg/kg	20 to 30 min pre‐induction	‐ Nausea ‐ Vomiting ‐ Dizziness ‐ Sedation
		IM	Same mechanism as PO; intramuscular route for moderate onset	2 to 5 mg/kg (premed) 4 to 5 mg/kg (sedation)	5 min pre‐induction	‐ Transient hallucinations ‐ Increased salivation ‐ Nausea ‐ Tachycardia
		IV	Same mechanism; intravenous route for very rapid onset	0.25 to 1 mg/kg IV (anxiolysis) 1 to 2 mg/kg (dissociation)	2 min pre‐induction	‐ Hallucinations ‐ Dissociative emergence ‐ Nausea ‐ Transient hypertension

GABA_A: gamma‐aminobutyric acid type A receptor; IM: intramuscular; IN: intranasal; IV: intravenous; min: minutes; MT₁/MT₂: melatonin receptor subtypes 1 and 2; NMDA: N‐methyl‐D‐aspartate; PO: oral (per os); PR: rectal (per rectum); SL: sublingual

Pharmacological interventions

Pharmacological approaches typically involve anxiolytic or sedative medications given prior to the induction of anaesthesia [19, 22, 23]. The most commonly used agent is midazolam, a benzodiazepine that produces anxiolysis, amnesia, and sedation by enhancing GABA_A receptor activity [22, 24]. Midazolam has a rapid onset and can be given orally, intranasally, rectally, or intravenously, making it practical for use in children. However, concerns about paradoxical reactions and over‐sedation in some cases have prompted exploration of alternatives [23, 25, 26, 27, 28].

For example, α₂‐adrenoceptor agonists such as clonidine and dexmedetomidine inhibit noradrenaline release via presynaptic α₂ receptors in the locus coeruleus, thereby reducing sympathetic outflow and inducing sedation and anxiolysis with minimal respiratory depression [23, 29, 30, 31, 32, 33, 34, 35]. Dexmedetomidine, in particular, has been used off‐label for paediatric premedication (via intranasal or oral routes) due to its combined sedative and analgesic properties [22, 36].

Melatonin, a hormone that regulates circadian rhythms, has also been studied as a premedication. By activating MT₁ and MT₂ melatonin receptors, it produces calming and sedative effects without respiratory depression [37, 38, 39, 40].

Another pharmacological option is ketamine at sub‐anaesthetic doses. Ketamine is an N‐methyl‐D‐aspartate (NMDA) receptor antagonist that can provide sedation, amnesia, and analgesia. Low‐dose ketamine (orally or intramuscularly) has been used as a premedicant, especially in uncooperative children, though its use is sometimes limited by side effects such as excessive salivation or hallucinations [41, 42, 43].

Each pharmacological agent has a distinct side‐effect profile, and their relative risks and potential advantages in children (e.g. ease of administration, taste, onset time) are considerations when selecting an appropriate premedication.

Non‐pharmacological interventions

Non‐pharmacological approaches encompass a wide range of psychological, behavioural, and environmental strategies aimed at preventing or alleviating anxiety without medication [8, 14]. They act by addressing the child's fears, redirecting their attention, teaching coping skills, or altering the sensory environment of the preoperative setting, and are usually tailored to the child's developmental stage and family context [44].

Distraction‐based techniques are amongst the most frequently studied interventions, including the use of audiovisual media (cartoons, movies), interactive games, and virtual reality. These interventions redirect the child's attentional focus away from the hospital environment and anxiety‐provoking stimuli [8, 45]. Randomised trials suggest that such interactive distractions can be as effective as midazolam in reducing preoperative anxiety, without the side effects of the medication [46, 47].

Therapeutic play and educational interventions use developmentally appropriate information and activities to familiarise children with the surgical experience. Strategies include hospital tours, role‐play with mock medical equipment, storybooks, or therapeutic dolls, all designed to explain the procedure in age‐appropriate terms. By gradually desensitising the child to medical equipment and procedures in a friendly manner, these interventions can reduce the fear of the unknown associated with surgery [48, 49, 50]. In one family‐centred trial, a multifaceted preparation programme (including hospital orientation, coping skills training, and parental coaching) significantly reduced children's anxiety and improved postoperative outcomes compared with standard care [16].

Parental involvement is another key approach: having a parent present during induction of anaesthesia ('parental presence at induction of anaesthesia' or PPIA) is widely practised to comfort the child. While evidence on its standalone efficacy is mixed, recent analyses indicate that, when parents are calm and adequately prepared, PPIA can produce a small reduction in a child's anxiety without prolonging the induction process. Furthermore, training and coaching parents on how to support and communicate with their child (e.g. using a calm voice, distraction, or relaxation techniques) may enhance the benefits of parental presence [32, 51, 52, 53, 54, 55, 56].

Other modalities include relaxation techniques (such as guided imagery, deep breathing exercises, or mindfulness) that help the child gain a sense of control and reduce physiological arousal. For example, guided imagery invites children to imagine themselves in a safe, fun scenario, which can lower heart rate and stress hormone levels associated with anxiety [57, 58, 59, 60]. Hypnotherapy and cognitive‐behavioural therapies (CBT) have also been explored for older children, teaching them to reframe negative thoughts about surgery and use coping imagery to stay calm [61, 62, 63, 64].

Complementary therapies are increasingly recognised for their calming effects. These include interventions such as aromatherapy, music therapy, massage, and animal‐assisted therapy. Aromatherapy (inhaling relaxing essential oils such as lavender or chamomile) can activate olfactory pathways linked to the limbic system and promote a sense of calm; clinical studies in adults and some paediatric settings suggest it significantly alleviates preoperative anxiety [65, 66]. Likewise, animal‐assisted therapy (such as a brief visit from a trained therapy dog prior to surgery) has been shown to lower state anxiety in hospitalised children through providing comfort and positive distraction [67, 68]. Massage therapy – for instance, a simple hand or foot massage shortly before surgery – can reduce sympathetic arousal, as evidenced by lower heart rate and blood pressure, and decrease observed anxiety levels in children [69]. Music therapy is another effective modality: listening to soothing music (recorded music via headphones) can induce relaxation, lower heart rate, and diminish perceived anxiety in the preoperative period [70, 71]. Live music therapy, delivered by a trained music therapist who can engage the child in singing or instrument play, also leverages rhythmic entrainment and emotional expression to reduce anxiety, and has shown benefits in paediatric clinical settings. Notably, combining music with other modalities (such as aromatherapy or distraction) may have synergistic effects on calming the child [70, 71].

In addition to these, environmental modifications (such as dimmed lighting, noise reduction, child‐friendly decor) may attenuate sensory overstimulation and help create a more soothing, developmentally supportive setting, lowering ambient arousal levels in the preoperative area [2, 72, 73, 74].

Overall, non‐pharmacological interventions tend to be safe and well‐received by families, but their effectiveness can vary, and they often require additional time, resources, or personnel training compared to pharmacological premedication alone.

Complex interventions

In real‐world clinical practice, healthcare professionals often use multimodal approaches to address preoperative anxiety – blending pharmacological and non‐pharmacological strategies tailored to each child's needs [19, 20, 32, 75]. These interventions are typically multi‐component, varying in delivery mode, timing, and intensity. The present review will classify such interventions according to the Cochrane Handbook Complex Interventions Framework (Chapter 17) [44].

Beyond considerations of efficacy and safety, the selection of an appropriate preoperative anxiety intervention in clinical practice is further influenced by practical considerations, including resource requirements, implementation costs, the need for trained personnel or specialised equipment, and the time available for preoperative preparation. These factors vary substantially across intervention types — from low‐cost strategies such as parental coaching to resource‐intensive approaches such as virtual reality or structured cognitive‐behavioural programmes — and are essential considerations for clinicians and healthcare decision‐makers weighing both effectiveness and feasibility.

Why it is important to do this review

Despite the large volume of available interventions, the optimal strategies for managing preoperative anxiety in school‐age children remain unclear.

The most recent Cochrane review by Manyande and colleagues (2015) is now over a decade old and focused exclusively on non‐pharmacological distraction interventions, pooling data from a broad paediatric age range (from infants to adolescents), and thereby limiting applicability to school‐age children, whose cognitive and emotional developmental stage warrants targeted analysis [76]. Subsequent reviews have reinforced the value of individual approaches, such as structured preparation and therapeutic play, educational materials, music therapy, virtual reality, video games, audiovisual technologies, tablet‐based distraction, and parental presence at induction. Notably, one review examined the direct comparison of video games versus midazolam, yet none of these reviews has provided an age‐specific, integrated comparison of both pharmacological and non‐pharmacological strategies [18, 19, 21, 48, 51, 70, 77, 78, 79, 80, 81, 82, 83, 84, 85].

More recently, Chen and colleagues (2025) and Li and colleagues (2025) conducted a network meta‐analysis of non‐pharmacological interventions, leaving the relative efficacy and safety of pharmacological agents and combined behavioural and educational approaches unexplored [14, 86].

Since 2015, the field has evolved substantially with the introduction of new pharmacological agents (e.g. α₂ agonists, melatonin) and emerging digital technologies (e.g. virtual‐reality environments, tablet‐based interactive applications). However, evidence remains fragmented across multiple reviews, none of which offer a comprehensive answer to the question: "Which intervention (or combination of interventions) is most effective at reducing preoperative anxiety in children aged 6 to 12 years?" Moreover, there is a dearth of high‐quality direct and indirect comparisons across intervention types; limited subgroup analyses to explore potential effect modifiers (such as child age, parental involvement, delivery mode, or surgical setting); and insufficient evaluation of longer‐term outcomes such as maladaptive postoperative behaviours.

These gaps underscore the need for a Cochrane review that: 1) includes solely studies involving primary/elementary‐school‐age children (6 to 12 years), thus avoiding dilution of age‐specific effects observed when multiple paediatric age groups are combined; 2) directly compares pharmacological and non‐pharmacological interventions (and their subtypes) using both pairwise and network meta‐analysis, permitting a hierarchical ranking of interventions in terms of both efficacy and safety; and 3) incorporates digital and pharmacological innovations trialled since 2015, ensuring that recommendations reflect contemporary clinical practice and meet the evolving needs of healthcare professionals, children, and families [26,87].

By addressing these gaps, this review will generate comprehensive, up‐to‐date evidence evaluating and comparing interventions to inform clinical guidelines and support evidence‐based perioperative care pathways. Ultimately, it will help optimise outcomes in paediatric surgery, reducing emotional distress, improving recovery trajectories and enhancing the overall surgical experience for school‐age children and their families.

Objectives

To compare the benefits and harms of pharmacological and non‐pharmacological preoperative interventions (alone or in combination) for reducing anxiety in school‐age children undergoing elective surgery under general anaesthesia, and to rank the interventions according to their efficacy and safety.

Methods

We will conduct this review in accordance with the Methodological Expectations of Cochrane Intervention Reviews (MECIR) standards and report it following the PRISMA 2020 statement and the PRISMA extension for Network Meta‐Analyses (PRISMA‐NMA) guidelines [88, 89, 90]. The protocol has been registered in PROSPERO [91]. We will document any amendments to eligibility criteria or planned analyses in the final review, with a clear description and rationale for each change.

Criteria for considering studies for this review

Types of studies

We will include randomised controlled trials (RCTs), whether using individual or cluster randomisation [92]. We will exclude cross‐over and quasi‐randomised trials and non‐randomised designs. No restrictions on language, geography, or publication status will be applied [93].

Types of participants

We will include studies enrolling school‐age children (6 to 12 years) scheduled for elective surgery under general anaesthesia, in day‐case or inpatient settings across any surgical speciality (whether minor or major procedures) [93].

Trials recruiting broader paediatric age ranges will be eligible if data for children aged 6 to 12 years are available (reported separately or obtainable from study authors). We will exclude studies if ≥ 20% of participants fall outside this age range and disaggregated data cannot be obtained.

Eligible studies must assess the child's preoperative anxiety using a validated instrument appropriate to this setting (e.g. modified Yale Preoperative Anxiety Scale (mYPAS) [15]).

Children with severe intellectual or neurodevelopmental disorders, where reliable assessment of anxiety is not feasible due to communication limitations or atypical behavioural responses, will also be excluded to ensure clinical and measurement homogeneity.

Children receiving ongoing pharmacological treatment for chronic psychiatric disorders (e.g. anxiolytic or other psychotropic medications) will be ineligible, as these agents may alter baseline anxiety levels or interact with preoperative interventions.

We will explicitly document any assumptions applied during data interpretation (e.g. inclusion of 'children and adolescents' populations up to age 18 years) in a 'Characteristics of included studies' table, and will discuss these in the 'Limitations of the evidence' section of the review.

We will apply no restrictions based on sex/gender, ethnicity, socioeconomic status, or geographical location.

Types of interventions

We will include both pharmacological and non‐pharmacological interventions administered during the preoperative period (from pre‐admission assessment to induction of anaesthesia) in children aged 6 to 12 years. Interventions may be delivered individually or in combination. For each trial arm, we will seek to extract details on timing, dose/regimen, duration, and delivery mode for all arms.

As noted in Description of the condition, we will exclude studies conducted in the context of emergency or urgent procedures, dental surgery, or interventions performed solely under sedation or local anaesthesia, as these settings differ substantially from elective general anaesthesia in terms of timing, predictability, and opportunity for standardised preoperative preparation, precluding meaningful comparison with the interventions under review.

Pharmacological interventions

We will include any anxiolytic or sedative premedication administered during the preoperative period, irrespective of dose, route (including oral, intranasal, intravenous, or rectal), or timing. We will exclude agents administered solely for induction or maintenance of anaesthesia. See Table 2.

Non‐pharmacological interventions

We will include any psychological, behavioural, or complementary therapy primarily designed to reduce preoperative anxiety. Examples include, but are not limited to, distraction‐based strategies, educational interventions, relaxation or cognitive‐behavioural techniques, parental presence or coaching, and complementary approaches such as aromatherapy and massage. We will exclude interventions that target only postoperative pain, general stress reduction, or satisfaction enhancement, without an explicit preoperative anxiety component. See Table 1.

Hybrid or multimodal interventions

Hybrid or multimodal interventions combine pharmacological and non‐pharmacological components, for example, oral midazolam plus mobile‐device‐based distraction. Where sufficient data exist, we will treat these interventions as distinct nodes in the network meta‐analysis and describe them according to the Cochrane Handbook for Systematic Reviews of Interventions (hereafter Cochrane Handbook) guidance on complex interventions (Chapter 17) [44].

Comparators

• Usual care: standard preoperative preparation (e.g. routine verbal or written information)

• Placebo or sham intervention: pharmacological placebo indistinguishable from active medication (e.g. sugar‐flavoured oral solution) or non‐pharmacological sham (e.g. recorded white noise instead of music)

• Active comparator: any other eligible intervention (pharmacological, non‐pharmacological, or hybrid)

Intervention groupings

Interventions will be grouped according to their:

• mechanism: pharmacological, non‐pharmacological, or hybrid/multimodal;

• delivery mode: digital (e.g. virtual reality, mobile applications) or face‐to‐face; and

• intensity/duration: single‐session versus multi‐session.

These categories will define the nodes for the network meta‐analysis. If additional eligible types are identified during screening, they will be evaluated and incorporated as distinct nodes (see Table 3).

3. Classification of eligible preoperative anxiety‐reduction interventions in school‐age children.

Intervention grouping	Description	Eligibility criteria
Control	Absence of any targeted preoperative anxiolytic strategy	‐ Standard care (verbal briefing, leaflets) ‐ Placebo (inert medication or sham procedure)
Pharmacological interventions	Medications administered before induction of anaesthesia to achieve anxiolysis via specific neurobiological pathways (GABAergic, adrenergic, melatonergic, NMDA)	Included classes (at standard paediatric doses): ‐ Benzodiazepines (midazolam, lorazepam) via IV/IN/PO ‐ α2‐adrenoceptor agonists (dexmedetomidine, clonidine) via IV/IN/PO/SL ‐ Melatonin (oral/SL) ‐ Sub‐anaestheticketamine (IM/IV/PO)
Non‐pharmacological interventions	Strategies targeting anxiety via psychological, attentional, or sensory mechanisms	‐ Educational interventions (videos, interactive books, hospital tours, web/mobile apps) ‐ Relaxation/cognitive‐behavioural techniques (CBT) (guided imagery, breathing/mindfulness exercises, clinical hypnotherapy, CBT coping skills, therapeutic storytelling, peer modelling) ‐ Distraction techniques (audiovisual, interactive (tablets/games), virtual reality, preparatory apps) ‐ Complementary therapies (acupuncture, aromatherapy, animal‐assisted therapy, massage, recorded music therapy) ‐ Environmental modifications (dimmed lighting, noise reduction, child‐friendly decor, minimal staff exposure) ‐ Parental involvement (parental presence at induction, structured coaching/support for parents) ‐ Creative‐arts and play (therapeutic play, art therapy, clown therapy)
Complex/multi‐component interventions	Any single programme that integrates two or more of the above pharmacological and/or non‐pharmacological components. Treated as a distinct node in the network analysis	Examples: midazolam + virtual reality distraction, multi‐session relaxation + parental coaching

CBT: cognitive‐behavioural therapy; IM: intramuscular; IN: intranasal; IV: intravenous; NMDA: N‐methyl‐D‐aspartate; PO: oral (per os); SL: sublingual; VR: virtual reality

Outcome measures

To be eligible, trials must include a validated measure of the child's preoperative anxiety (e.g. mYPAS, STAIC‐S, or VAS‐A) [15, 94, 95]. We will exclude trials that do not report this.

Critical outcomes

We have identified the following outcomes as critical for decision‐making, based on core outcome sets (COMET Initiative) and their importance to stakeholders (patients, clinicians, and policymakers) [96].

Each outcome is aligned with a specific perioperative time point as detailed below.

Time point	Period	Description
T1	Preoperative	From baseline to immediately before induction of anaesthesia
T2	Perioperative	From induction to discharge from the post‐anaesthesia care unit (PACU)
T3	Early postoperative	Up to seven days after surgery

Preoperative anxiety (T1)

Change in the child’s anxiety level from baseline (first preoperative assessment) to immediately before induction of anaesthesia. Our preferred instruments (in hierarchical order) are as follows.

• Modified Yale Preoperative Anxiety Scale (mYPAS) [15]

• State‐Trait Anxiety Inventory for Children – State subscale (STAIC‐S) [94]

• Visual Analogue Scale for Anxiety (VAS‐A) [95]

• Children's Emotional Manifestation Scale (CEMS) [97, 98]

• Other validated paediatric anxiety scales [99]

Where multiple time points are reported (e.g. holding area, entry to operating theatre, mask induction), we will use anxiety at induction for the main analysis, and we will explore earlier assessments in sensitivity analyses.

Cooperation during induction of anaesthesia (T2)

Behavioural compliance assessed by the Induction Compliance Checklist (ICC) or equivalent validated tool, reflecting the child's cooperation during separation from parents and placement of a mask or intravenous line [100, 101].

Emergence delirium (T2)

Incidence or severity of agitation or delirium during emergence from anaesthesia, measured using the Paediatric Anaesthesia Emergence Delirium (PAED) scale or equivalent, in the Post‐Anaesthesia Care Unit (PACU) immediately after awakening [102, 103, 104].

Adverse events (T1 to T3)

Any intervention‐related complications or harms. For pharmacological interventions: respiratory depression, oxygen desaturation, haemodynamic instability, paradoxical agitation, or other drug‐related side effects. For non‐pharmacological interventions: minor or rare adverse effects (e.g. discomfort from devices, sensory overstimulation) and intervention discontinuation.

We will extract all reported adverse events, withdrawals due to adverse effects, and relevant indicators of staff or parent acceptability.

Important outcomes

The following outcomes are important for understanding broader clinical effects but are not primary drivers of the review's conclusions.

1. Physiological stress markers (T1 to T2)

Objective indicators of autonomic arousal such as heart rate, blood pressure, or salivary cortisol concentration, measured from baseline to induction of anaesthesia.

2. Postoperative pain (T3)

Pain intensity measured in the PACU and within 24 hours post‐surgery using validated paediatric scales (e.g. FLACC ‐ Face, Legs, Activity, Cry, Consolability, Wong–Baker FACES, Visual Analogue Scale for Pain (VAS‐Pain)) [105, 106]. We will analyse data at the earliest postoperative time point and at 24 hours, where available.

3. Postoperative maladaptive behaviours (T3)

Incidence of behavioural changes following surgery (e.g. sleep disturbances, separation anxiety, regression) measured by validated parent‐report tools such as the Post‐Hospitalisation Behaviour Questionnaire (PHBQ) within seven days of discharge [107, 108].

4. Rescue analgesic use (T3)

Binary outcome representing the administration of additional ('rescue') analgesia beyond the planned regimen in the postoperative period, as a proxy for inadequate anxiolysis or analgesia.

Instrument hierarchy and data handling

When multiple validated instruments are reported for the same domain, we will extract data for all of them and synthesise according to a predefined hierarchy, prioritising the most widely validated and commonly used tool (e.g. mYPAS for anxiety [15]).

If a study reports an eligible outcome without specifying the measurement instrument, we will contact the study authors for clarification (one follow‐up after 10 days). We will document unresolved cases as limitations in a 'Characteristics of included studies' table.

Grouping of outcomes for synthesis

We will group outcomes into clinically coherent categories according to the:

• underlying domain (e.g. anxiety, cooperation, pain, physiological stress);

• time point (T1 to T3); and

• type of measure (observational, self‐report, physiological).

Our selection and hierarchy of outcomes were informed by core outcome sets for paediatric perioperative research (COMET Initiative) and by stakeholder consultation (children, parents, clinicians). These domains represent the most relevant short‐term effects of preoperative anxiety interventions in school‐age children and enable consistent synthesis across trials. A detailed summary of the specific instruments and assessment time points for each critical and important outcome is presented in Table 4.

4. Specific outcome measures for each critical and important outcome in school‐age children undergoing elective surgery.

Time point	Outcome domain	Measurement instrument(s)
Critical outcomes
T1 ‐ Preoperative (before induction of anaesthesia)	Child preoperative anxietya	1. mYPAS (modified Yale Preoperative Anxiety Scale)
		2. STAIC‐S (State–Trait Anxiety Inventory for Children – state subscale)
		3. VAS‐A (Visual Analogue Scale for Anxiety)
		4. CEMS (Children’s Emotional Manifestation Scale)
		5. Other validated paediatric anxiety scales
T2 ‐ Perioperative (induction or emergence period)	Cooperation during inductionb	1. ICC (Induction Compliance Checklist)
		2. Other equivalent behavioural rating instrument
T2 ‐ Perioperative (induction or emergence period)	Emergence deliriumc	1. PAED scale (Paediatric Anaesthesia Emergence Delirium scale)
		2. Other validated emergence‐delirium instrument
T1–T3 (pre‐induction ‐ up to 7 days)	Adverse eventsd	1. Incidence of oversedation
		2. Paradoxical reactions
		3. Respiratory depression
		4. Nausea/vomiting
		5. Other intervention‐related adverse effects
Important outcomes
T2/T3 (0 to 7 days)	Pain intensitye	1. FLACC scale (Face, Legs, Activity, Cry, Consolability)
		2. Wong‐Baker FACES Pain Rating Scale
		3. Visual analogue scale (pain)
		4. Other validated instrument
T1/T2 (baseline to induction)	Physiological stress markers	1. Δ Heart rate (baseline to induction)
		2. Δ Blood pressure (baseline to induction)
		3. Salivary cortisol concentration (pre‐induction)
T3 (up to 7 days)	Postoperative maladaptive behavioursf	1. PHBQ (Post Hospitalisation Behaviour Questionnaire)
		2. Other equivalent parent‐reported tool

^aAnxiety at induction will be used for primary synthesis; earlier measures (e.g. in holding area) will be analysed in sensitivity analyses.

^bCooperation reflects behavioural compliance during separation or mask/IV placement.

^cEmergence delirium assessed in the post‐anaesthesia care unit (PACU) immediately after awakening.

^dIncludes all adverse effects and withdrawals due to the intervention.

^ePain measured in post‐anaesthesia care unit (PACU) or within 24 hours post‐surgery.

^fBehaviours assessed within seven days post‐discharge using parent‐report tools.

Search methods for identification of studies

Electronic searches

We will search the following bibliographic databases from inception, without restrictions on date, language, or publication status.

• Cochrane Central Register of Controlled Trials (CENTRAL) (latest issue, in the Cochrane Library)

• MEDLINE (Ovid)

• PsycINFO (via EBSCOHost)

• CINAHL (via EBSCOHost)

• SciELO

• Scopus

• Web of Science (Core Collection)

In accordance with MECIR Standard C27, we will also search two clinical trial registries to identify ongoing or unpublished studies [89, 109].

• ClinicalTrials.gov

• World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)

Although the Cochrane Handbook notes that CENTRAL already incorporates records from the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov, we will nevertheless perform an additional search in ICTRP to check for any recent trials not yet indexed in CENTRAL [109, 110]. We will provide the complete draft search strategies and filters in Supplementary material 1.

To ensure transparency and scientific integrity, we will check all included or eligible studies for post‐publication amendments, including errata, corrigenda, expressions of concern, and retractions. We will verify the publication status of each included record using sources such as PubMed, Retraction Watch Database (https://retractionwatch.com/), and journal publisher websites. We will document any identified amendments, and we will flag affected studies for sensitivity analysis or exclusion, as appropriate.

Search strategies will be developed and peer‐reviewed by an experienced information specialist, following the Peer Review of Electronic Search Strategies (PRESS) checklist [111].

For each database, a tailored search syntax will be devised, combining controlled vocabulary terms (e.g. MeSH, CINAHL Subject Headings) with free‐text keywords relating to:

• population (paediatric, child, school‐age);

• concept (preoperative anxiety, surgical preparation, perioperative fear, psychological stress); and

• intervention (pharmacological, non‐pharmacological, behavioural, educational, complementary).

Searching other resources

In addition to the planned electronic database searches, we will use several supplementary methods to identify additional or unpublished studies, as detailed below.

• Screening reference lists of all included studies and relevant systematic reviews

• Forward‐citation tracking for included studies using Scopus

• Contacting study authors, experts, and relevant professional societies to identify ongoing or unpublished work

• Searching clinical trial registries (as noted above) for studies registered but not yet reported

To minimise publication and reporting biases, we will also search grey literature and regional sources, including the following.

• Repositórios Científicos de Acesso Aberto em Portugal (RCAAP)

• Google Scholar (first 10 pages)

• European Society of Paediatric Anaesthesia materials

• OpenGrey

• Networked Digital Library of Theses and Dissertations (NDLTD)

Grey‐literature and non‐peer‐reviewed records (e.g. theses, dissertations, reports) will be documented in a dedicated table, separate from peer‐reviewed publications, specifying the source, search date, and number of records identified.

We will examine the impact of including non‐peer‐reviewed sources on pooled estimates as part of our planned sensitivity analyses (see Sensitivity analysis).

We will record all supplementary search methods, contacts with experts, and registry results in the review's audit trail to ensure reproducibility and transparency.

Data collection and analysis

Selection of studies

We will import all records retrieved from the electronic and supplementary searches into Rayyan (https://www.rayyan.ai/) for automatic deduplication and initial organisation [112].

Two review authors will independently screen titles and abstracts against the inclusion criteria, following a pilot calibration exercise to ensure consistency and shared understanding of the eligibility criteria. Any record deemed potentially eligible by either review author will be assessed in full text by both review authors independently. Review authors will remain blinded to each other's decisions throughout the screening process.

To optimise efficiency and consistency, we will employ Cochrane's Screen4Me workflow (with support from an information specialist) during the initial screening phase. Screen4Me comprises three components: (1) known assessments, which match records to those already screened in Cochrane Crowd and labelled as 'RCT' or 'not RCT'; (2) an RCT classifier, a machine‐learning model that distinguishes RCTs from non‐RCTs; and (3) crowdsourced screening via Cochrane Crowd for records not definitively classified by the first two components [113, 114, 115, 116].

Disagreements at any stage will first be discussed between the review authors to reach consensus. If agreement cannot be achieved, a third review author will adjudicate. We will document all resolution decisions, justifications, and version history within Rayyan [112], and we will present the reasons for exclusions of full‐text articles in a PRISMA flow diagram. When multiple publications report on the same trial, we will collate them into a single study record. If eligibility or study details remain unclear, we will contact the study authors for clarification (one follow‐up after 10 days).

Reports published in languages other than English, Portuguese, or Spanish will be translated with assistance from health‐literate native speakers or, where necessary, AI‐assisted translation tools, such as DeepL Pro (https://www.deepl.com/pro), followed by human verification [117]. We will log all screening decisions, author communications, and version control within the review's screening audit trail for transparency. Any review author directly involved in any trial with potential for inclusion will be recused from assessing that study’s eligibility, in accordance with Cochrane’s conflict‐of‐interest policy [118].

Data extraction and management

We will employ a study‐centric data management workflow, using Rayyan for screening and Covidence (https://www.covidence.org/) as the primary platform for full‐text review, data extraction, and risk‐of‐bias assessment [112, 119]. Two review authors will independently extract data in duplicate using a standardised and piloted extraction form in Covidence [119]. We will test the form on a random sample of five included studies to ensure completeness and clarity, aiming for at least 90% inter‐rater agreement before finalising the form. We will resolve disagreements during data extraction through discussion; unresolved cases will be referred to a third review author. We will document consensus decisions and explanatory notes within Covidence.

Review authors directly involved in any included trial will be recused from data extraction and risk‐of‐bias assessment for that study, and from GRADE evaluation of results that include that study, in accordance with Cochrane’s conflict‐of‐interest policy [118, 120, 121].

Data items to be extracted

From each included study, we will extract the following data.

• Study identification: authors, publication year, country, funding source(s), conflict‐of‐interest statements

• Participant characteristics: mean age (and range), sex distribution, baseline anxiety severity (instrument and score), surgical type

• Intervention characteristics

  • Pharmacological: agent, dose, route of administration, timing

  • Non‐pharmacological: category, delivery mode, frequency, duration

• Comparator details: description of usual care, placebo, active comparator

• Outcomes: data for all prespecified domains and time points, as defined in the Outcome measures section. Where multiple measures are reported for the same domain, we will extract all data, and we will conduct our synthesis following the predefined instrument hierarchy.

• Potential effect modifiers and co‐interventions: child age group (6 to 8 years versus 9 to 12 years), funding source/sponsorship (industry versus non‐industry versus none), surgical setting (day‐case versus inpatient), parental involvement (present versus absent), type of surgery, and mode of delivery (digital versus face‐to‐face)

Where outcome data are presented as medians with interquartile ranges, or other non‐standard statistics, we will convert these to means and standard deviations using validated transformation methods recommended in the Cochrane Handbook [122, 123].

We will export all extracted data from Covidence into Review Manager (RevMan) software for quantitative synthesis, risk‐of‐bias visualisation, and preparation of summary of findings tables [119, 124]. We will provide a template of the data‐extraction form in Supplementary material 2, and we will summarise the extracted information in a 'Characteristics of included studies' table (see Table 5) [125].

5. Characteristics of included studies (example).

Study ID	Design	N (I/C)	Age (yrs)	Intervention	Comparator	Primary outcome	Effect (95% CI)	RoB	Funding
Smith 2023	Parallel RCT	30/30	6 to 12 (8 ± 1.5)	Midazolam 0.5 mg/kg PO 30 min preop	Placebo	mYPAS score (T1)	–15.2 (–20.1 to –10.3)	Low	Industry

C: control arm; I: intervention arm; min: minutes; mYPAS: modified Yale Preoperative Anxiety Scale; preop: preoperatively; RoB: overall risk of bias; T: time point; yrs: years

Risk of bias assessment in included studies

We will assess the risk of bias of all included randomised trials using the Cochrane risk of bias tool RoB 2, applying the cluster‐RCT extension where appropriate [92, 126, 127].

Two review authors will independently evaluate each of the following five RoB 2 domains.

• Bias arising from the randomisation process

• Bias due to deviations from intended interventions

• Bias due to missing outcome data

• Bias in measurement of the outcome

• Bias in selection of the reported result

Each domain will be rated 'low risk of bias', 'some concerns', or 'high risk of bias', and an overall judgement will be generated according to the RoB 2 algorithm. We will follow the intention‐to‐treat principle (effect of assignment to intervention) for all assessments.

Review authors will be blinded to each other's assessments. We will resolve any disagreements by discussion or, if consensus cannot be reached, by consultation with a third review author. We will record all final judgements and rationales in Covidence and export them to RevMan for visualisation in two risk‐of‐bias figures [119, 124].

Although this review will include only randomised trials, we anticipate that blinding of participants, parents, and personnel may not be feasible for many non‐pharmacological or hybrid interventions, which may increase the risk of performance bias. We will capture such risks within RoB 2 domain 'bias due to deviations from intended interventions', which is consistent with current Cochrane guidance.

We will perform risk‐of‐bias assessments only for the critical outcomes defined in this protocol (preoperative anxiety, cooperation during induction, emergence delirium, and adverse events).

Where study reports lack sufficient detail to inform a domain judgement, we will contact study authors via email, and send one reminder if no response is received within 10 days. We will classify any unresolved uncertainties as 'some concerns'.

Measures of treatment effect

For continuous outcomes (e.g. preoperative anxiety scores, physiological stress markers), we will pool data using standardised mean difference (SMD; Hedges' g) with 95% confidence intervals (CI) when trials report results using different measurement scales (e.g. mYPAS [15], STAIC‐S [94], VAS‐A [95]). Where all included trials for a given outcome domain use the same validated instrument, we will present mean differences (MD) on the original scale to facilitate clinical interpretation.

We will interpret standardised effect sizes using conventional thresholds according to Cohen and colleagues: 0.2 (small), 0.5 (moderate), and 0.8 (large) [128].

Where studies report non‐standard summary statistics (e.g. medians, interquartile ranges, P values, confidence intervals), we will convert these into means and standard deviations using validated methods (e.g. Wan and colleagues 2014 [129]), following Cochrane Handbook recommendations [122].

Given the anticipated use of multiple anxiety instruments, we will apply our predefined outcome‐instrument hierarchy. However, to address residual instrument heterogeneity, we will perform sensitivity analyses examining whether instrument type affects pooled SMD estimates. Where sufficient data allow, we will also undertake exploratory meta‐regression incorporating anxiety instrument type as a covariate to test for potential effect modification.

For binary outcomes (such as the incidence of emergence delirium, rescue analgesic use, or adverse events), we will calculate risk ratios (RRs) with 95% CI. Where informative, we will derive absolute risk differences by applying pooled RRs to a representative baseline risk. If a trial reports odds ratios (ORs), we will convert these to RRs when sufficient data are available.

Unit of analysis issues

All included studies will be randomised controlled trials. We anticipate three trial designs: parallel (two‐arm), cluster‐randomised, and multi‐arm trials. We will handle unit‐of‐analysis issues as follows.

For parallel trials with two arms, no specific adjustment will be required; we will extract reported treatment effect estimates and their variances directly.

In cluster‐randomised trials, we will adjust standard errors to account for clustering by using intraclass correlation coefficients (ICC) supplied in the reports. If ICCs are not presented, we will contact study authors via email. If the ICCs are unavailable, we will borrow a plausible ICC from similar studies and apply the design effect adjustment as described in Chapter 11 of the Cochrane Handbook [130]. We will use adjusted sample sizes and variances in all relevant analyses, and we will explore the impact of assumed ICC values in sensitivity analyses.

For multi‐arm trials, when conducting pairwise meta‐analysis, we will divide the shared comparator group's sample size evenly across each relevant comparison to prevent double‐counting. In the network meta‐analysis, correlations between effect estimates from multi‐arm studies will be modelled using a multivariate random‐effects framework, as outlined in the Cochrane Handbook Chapter 6 [122].

If other non‐standard RCT designs are identified, we will include them using the generic inverse‐variance method, with appropriate unit‐of‐analysis corrections based on study design characteristics. We will document and report all adjustment methods and assumptions fully in the review.

Dealing with missing data

We will seek to minimise the impact of missing data through a combination of author contact, appropriate imputation methods, and sensitivity analyses.

Where outcome data are incomplete or unclear, we will contact study authors via email, and send one reminder after 10 days if no response is received. We will record all correspondence and author responses in Covidence [119].

For continuous outcomes lacking means or standard deviations, or both, we will derive these summary statistics from alternative reported metrics (e.g. standard errors, confidence intervals, P values, medians, and interquartile ranges), using established methods recommended in the Cochrane Handbook [122]. If data cannot be obtained from authors, we will use these derived estimates. Where multiple imputations are possible, we will select the most conservative estimate to minimise the risk of bias. We will then perform sensitivity analyses excluding studies with imputed data to assess their influence on pooled estimates.

For dichotomous outcomes with incomplete event data, our analyses will follow the intention‐to‐treat principle, including all randomised participants in their assigned groups. Where participants are lost to follow‐up or have missing outcome data, we will apply worst‐case and best‐case imputation scenarios.

• Worst‐case scenario: all missing participants in the intervention group are assumed to have experienced the adverse event, and none in the control group.

• Best‐case scenario: no participants in the intervention group are assumed to have experienced the event, and all participants in the control group are assumed to have experienced the event.

We will explore the impact of these assumptions by comparing pooled estimates across scenarios.

For cluster‐randomised trials, if intraclass correlation coefficients (ICCs) are not reported, we will contact study authors or borrow plausible ICC values from similar studies, adjusting standard errors using the design‐effect approach (Cochrane Handbook, Chapter 11) [130]. If neither actual nor derivable data can be obtained for a given study or outcome, we will exclude the study from quantitative synthesis but describe it narratively to maintain transparency.

We will fully report all imputation procedures, assumptions, and sensitivity analyses relating to missing data in a 'Characteristics of included studies' table and explicitly discuss these in the Results and Discussion sections of the review.

Reporting bias assessment

We will evaluate the risk of bias due to missing results in each synthesis (arising from selective non‐reporting of outcomes or small‐study effects) by applying both graphical and statistical approaches [131].

Pairwise meta‐analysis

For pairwise comparisons that include at least 10 studies, we will assess small‐study effects and potential publication bias using contour‐enhanced funnel plots. Funnel plot asymmetry will be formally tested using Egger's regression test for continuous outcomes and Harbord's test for dichotomous outcomes [132].

Where fewer than 10 studies contribute to a meta‐analysis, we will forego formal tests. Instead, we will conduct a structured narrative assessment of selective outcome reporting by comparing trial registry entries, published protocols, and final reports to identify potential inconsistencies or missing results, which we will document transparently in the review.

Network meta‐analysis

For the network meta‐analysis, we will assess small‐study effects by visual inspection of comparison‐adjusted funnel plots and by evaluating inconsistency (disagreement between direct and indirect evidence), which may reflect reporting bias in some comparisons.

We will explore network inconsistency using both the design‐by‐treatment interaction model (global) and node‐splitting (local) approaches, as recommended in Chapter 11 of the Cochrane Handbook [130].

Where outcome reporting bias is suspected (such as outcomes listed in trial registries but unreported in publications), we will contact study authors to request clarification or missing data, documenting all correspondence.

Two review authors will independently assess and record the risk of bias due to missing results for each outcome, with supporting justifications. We will resolve disagreements by discussion or, if necessary, by consultation with a third review author. We will transparently report all assessments in the 'Risk of bias due to missing results' section of the review, and they will be visually summarised using funnel and comparison‐adjusted plots.

Synthesis methods

To synthesise the evidence, we will perform pairwise meta‐analyses for direct head‐to‐head comparisons and a network meta‐analysis to integrate direct and indirect evidence, enabling simultaneous comparison and ranking of multiple preoperative interventions according to their efficacy and safety. We will group studies into clinically meaningful comparisons corresponding to the predefined intervention nodes (see Types of interventions).

Pairwise meta‐analysis

Where at least two studies contribute data for a given comparison, we will undertake a random‐effects meta‐analysis to account for between‐study variability. We will calculate pooled effect estimates using inverse‐variance weighting, with the between‐study variance (τ²) estimated by restricted maximum likelihood (REML). We will derive confidence intervals using the Hartung–Knapp–Sidik–Jonkman (HKSJ) method when three or more studies are available and heterogeneity is greater than zero; otherwise, we will apply a Wald‐type approach [133].

Statistical heterogeneity will be quantified using the between‐study variance (τ²) and the inconsistency statistic (I²) with corresponding 95% confidence intervals. We will present prediction intervals to illustrate the expected range of true effects in comparable future settings. We will interpret heterogeneity in light of clinical and methodological diversity rather than based solely on arbitrary I² thresholds. We will conduct sensitivity analyses by excluding studies judged to be at high risk of bias and by applying alternative τ² estimators (e.g. DerSimonian‐Laird) to test the robustness of pooled estimates [134].

Structured synthesis without meta‐analysis

When meta‐analysis is not feasible (such as when only one trial addresses an outcome or when studies are too heterogeneous), we will resort to a structured synthesis without meta‐analysis (SWiM). In such cases, we will tabulate effect estimates by intervention node and time point, order comparisons by effect magnitude and risk of bias, and describe observed patterns narratively.

Network meta‐analysis

For the network meta‐analysis (NMA), we will use a frequentist multivariate framework implemented in netmeta (R) [135] to synthesise direct and indirect comparisons simultaneously. We will express effect sizes as standardised mean differences (SMDs) for continuous outcomes and risk ratios (RRs) for dichotomous outcomes, both with 95% confidence intervals. We will apply the HKSJ adjustment when there are at least three studies and heterogeneity exceeds zero; otherwise, we will use the Wald‐type method [130].

We will assess the transitivity assumption underpinning NMA by evaluating the similarity of studies across key effect modifiers (e.g. child age, surgical setting, delivery mode, baseline anxiety severity, intervention duration, and intensity). We will examine consistency between direct and indirect evidence using design‐by‐treatment interaction models and node‐splitting approaches, with inconsistency quantified where possible. If substantial inconsistency is detected, we will explore clinical or methodological explanations and, if required, restrict the network to preserve validity.

Hybrid or multi‐component interventions will be treated as distinct nodes, following Chapter 17 of the Cochrane Handbook on complex interventions. We will extract and report data on intervention components, delivery fidelity, and contextual factors that may influence or modify intervention effects [44].

Ranking and interpretation of interventions

We will estimate ranking probabilities for each intervention using the surface under the cumulative ranking curve (SUCRA), expressed as percentages representing the likelihood that each intervention ranks best or near‐best [136]. Where absolute measures are needed for clinical or policy interpretation, we will re‐express pooled RRs as absolute risk reductions [122]. We will present all syntheses with corresponding forest plots and league tables, displaying pairwise comparisons alongside SUCRA values [133, 137].

Multiplicity control

To minimise the risk of false‐positive findings arising from multiple testing across outcomes and comparisons, we will adopt a hierarchical approach to hypothesis testing. For critical outcomes, we will use a conservative two‐sided alpha of 0.025, following the approach of Jakobsen and colleagues [138]. For important outcomes, we will apply multiplicity adjustments (e.g. the Benjamini‐Hochberg procedure to control the false discovery rate at 5% [139]), particularly in exploratory subgroup and meta‐regression analyses. We will report both adjusted and unadjusted results to maintain transparency.

Software

We will perform all primary analyses using RevMan for pairwise meta‐analysis, and in R using the metafor, netmeta, and gemtc packages for network meta‐analysis and meta‐regression models [124, 140].

Investigation of heterogeneity and subgroup analysis

We will explore whether variation in intervention effects can be explained by key clinical or methodological factors through subgroup analyses and, where data permit, meta‐regression. These analyses will also inform the assessment of transitivity in the network meta‐analysis by evaluating the similarity of effect modifiers across comparisons.

We will examine the following five prespecified study‐level effect modifiers, which reflect hypothesised sources of heterogeneity and transitivity assumptions.

1. Child age group (6 to 8 years versus 9 to 12 years)

2. Funding source (industry versus non‐industry versus none)

3. Surgical setting (day‐case versus inpatient)

4. Parental involvement (present versus absent)

5. Mode of delivery (digital versus face‐to‐face)

Although we plan to extract the type of surgery the child is undergoing for descriptive purposes and to inform the assessment of transitivity, it will not be used as a formal effect modifier in subgroup analyses. We anticipate the following directions of effect: younger children (6 to 8 years) may derive greater benefit from non‐pharmacological interventions; industry‐sponsored trials may yield larger effect sizes; day‐case procedures may show different patterns due to shorter preparation time; parent‐involved interventions may produce stronger anxiety reduction; and digital formats may differ in effectiveness from face‐to‐face approaches.

We will conduct subgroup analyses on study‐level contrasts, assigning each trial to a single subgroup per effect modifier. We will perform Chi² tests for interaction in RevMan to assess statistical evidence for subgroup differences [124]. When 10 or more studies report the same outcome, we will fit meta‐regression models using the metafor package in R to estimate the strength and direction of associations between covariates (categorical or continuous) and intervention effects [140].

If fewer than 10 studies contribute, or if covariate data are insufficiently reported, we will not attempt formal modelling but will present a structured narrative comparison of results across subgroup categories.

All subgroup and meta‐regression findings — including interaction P values and regression coefficients — will be interpreted cautiously, and discussed in light of potential ecological bias, multiple testing, and limited power.

To maintain coherence with our outcome hierarchy, our subgroup exploration will focus primarily on critical outcomes (preoperative anxiety, cooperation, emergence delirium, adverse events). We will explicitly state that these are exploratory results and are for the purpose of generating hypotheses.

Equity‐related assessment

We will not formally investigate health inequity in this review, as our focus is on comparing the efficacy and safety of preoperative anxiety interventions across the general school‐age population (6 to 12 years) rather than on evaluating differential effects across sociodemographic subgroups.

However, in line with Cochrane Handbook guidance (Chapter 16), we will extract and report study‐level data on relevant contextual or equity‐related factors (e.g. socioeconomic status, parental education, healthcare access, or country income classification) where available. During data synthesis and interpretation, we will consider how these factors may affect the applicability and transferability of findings to other populations and healthcare settings.

Specifically, we will comment on whether the included evidence disproportionately represents high‐income settings, whether interventions rely on resources unavailable in low‐resource contexts, and whether any subgroup effects are suggested in the original studies. No separate equity‐focused subgroup analyses or summary of findings tables for disadvantaged groups are planned [141].

Sensitivity analysis

To assess the robustness of our findings, we will conduct a series of sensitivity analyses examining the influence of key methodological choices and assumptions. These analyses will primarily focus on our critical outcomes and will include the following.

1. Risk of bias: we will repeat primary pairwise and network meta‐analyses after excluding studies that we judge to be at overall high risk of bias, retaining only those rated low risk or some concerns.

2. Missing data imputation: we will repeat analyses after excluding studies where means and standard deviations were derived from medians or interquartile ranges.

3. Heterogeneity‐variance estimator: our main random‐effects analyses will use restricted maximum likelihood (REML) to estimate between‐study variance (τ²). We will compare these results with those obtained using the DerSimonian–Laird estimator and examine any material differences in effect sizes or uncertainty [134, 142].

4. Alternative effect measures: for rare dichotomous outcomes (event rate < 5%), we will compare pooled risk ratios (RRs) and odds ratios (ORs) to ensure conclusions are not sensitive to the chosen metric.

5. Model specification: although our main meta‐analyses will employ the random‐effects model, we will compare random‐effects and fixed‐effect analyses to test sensitivity to assumptions about between‐study variation.

6. Cluster‐RCT adjustment: we will exclude cluster‐randomised trials or apply alternative intraclass correlation coefficients (ICCs) to assess the impact of clustering corrections.

7. Anxiety instrument type: we will examine whether pooling data from different preoperative anxiety measurement instruments (e.g. mYPAS, STAIC‐S, VAS‐A) affects the direction or magnitude of the pooled standardised mean difference, by repeating the primary analysis restricted to studies using the same instrument.

We will compare results from sensitivity analyses quantitatively, examining changes in point estimates and confidence intervals rather than relying on significance testing. We will present findings alongside the main analyses and discuss them in terms of their implications for the stability and certainty of the evidence base [133].

Certainty of the evidence assessment

We will assess the certainty (confidence) in the evidence for each critical and important outcome using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach, as outlined in Chapter 14 of the Cochrane Handbook and the GRADE Handbook [121, 143].

For pairwise meta‐analyses, we will judge the certainty of the evidence across the five standard GRADE domains [121].

• Risk of bias: based on RoB 2 assessments for each outcome

• Inconsistency: considering the magnitude and direction of heterogeneity, overlap of confidence intervals, and credibility of subgroup explanations

• Indirectness: assessing whether populations, interventions, comparators, and outcomes directly address the review question

• Imprecision: judged through 95% CIs, optimal information size, and clinical decision thresholds

• Publication bias: informed by funnel plot asymmetry and selective outcome reporting assessments

According to the GRADE system, each outcome is initially rated as high‐certainty evidence (as it is drawn from RCTs), but it may be downgraded by one or two levels for serious or very serious concerns within these domains. The certainty ratings are high, moderate, low, or very low. In the summary of findings tables, we will provide detailed justifications for our judgements of the certainty of the evidence for all critical outcomes.

For our network meta‐analysis, we will apply the CINeMA (Confidence in Network Meta‐Analysis) framework—developed in collaboration with the GRADE Working Group— to evaluate the credibility of the network estimates [144]. CINeMA is used to assess the following six domains, which are conceptually aligned with GRADE.

1. Within‐study bias (risk of bias in included trials)

2. Across‐studies bias (publication and reporting bias)

3. Indirectness

4. Imprecision

5. Heterogeneity

6. Incoherence (disagreement between direct and indirect evidence)

We will rate each domain as 'no concerns', 'some concerns', or 'major concerns', and we will classify our overall confidence in each NMA estimate as high, moderate, low, or very low following the CINeMA algorithm [144].

When both direct and indirect evidence are available for a comparison, we will present direct GRADE assessments for pairwise comparisons; indirect and mixed GRADE assessments derived from CINeMA; and a narrative integration of confidence ratings across the network to highlight consistent or conflicting patterns.

Summary of findings tables

We will prepare summary of findings (SoF) tables for all critical outcomes using RevMan and GRADEpro GDT software [120, 124]. For the NMA, we will follow the 2019 guidance by Yepes‐Nuñez and colleagues, and present one summary of findings table per outcome, showing both relative and absolute estimates for all key interventions compared to the reference (usual care or placebo) [145].

Each summary of findings table will include the following.

• Summary of pooled effect estimates and 95% CIs (and prediction intervals, where available)

• Number of participants and studies

• SUCRA rankings or treatment hierarchy

• Certainty ratings and explanations for downgrading

• Absolute risk reductions where applicable

We will document all judgements, rationales, and evidence profiles transparently in the SoF tables and CINeMA outputs, ensuring reproducibility [144].

Consumer involvement

A parent whose child had previously undergone elective surgery under general anaesthesia was actively involved in the development of this protocol. This consumer representative contributed to shaping the research questions, selecting and prioritising the outcomes, and refining eligibility criteria, thereby ensuring the review addresses the real‐world priorities, values, and concerns of families navigating paediatric surgery [146]. A plain language summary, standard for all Cochrane reviews, will accompany the published review. In addition, a concise glossary of key terms for consumers has been developed to explain complex terminology in plain language, further enhancing accessibility for non‐expert readers (Supplementary material 3). Both the glossary and the plain language summary were informed by the consumer representative's input.

Supporting Information

Supplementary materials are available with the online version of this article: 10.1002/14651858.CD016330.

Supplementary materials are published alongside the article and contain additional data and information that support or enhance the article. Supplementary materials may not be subject to the same editorial scrutiny as the content of the article and Cochrane has not copyedited, typeset or proofread these materials. The material in these sections has been supplied by the author(s) for publication under a Licence for Publication and the author(s) are solely responsible for the material. Cochrane accordingly gives no representations or warranties of any kind in relation to, and accepts no liability for any reliance on or use of, such material.

Supplementary material 1 Search strategies

Supplementary material 2 Data extraction form

Supplementary material 3 Glossary of key terms for consumers

New

Additional information

Contributions of authors

IME: conceived the review; co‐led the protocol development; designed search strategy; drafted data‐extraction forms; wrote and revised the protocol.

RP: co‐led the protocol development; critically revised the protocol.

MPS: provided clinical expertise on paediatric anxiety interventions; reviewed and edited all manuscript drafts.

FS: senior methodological advisor; reviewed and refined data synthesis, heterogeneity, and sensitivity analysis plans; provided statistical input on network meta‐analysis models; contributed to editing and sign‐off of the protocol.

MRS: provided clinical expertise on paediatric anxiety interventions; senior methodological advisor; reviewed and refined data synthesis, heterogeneity, and sensitivity analysis plans; provided statistical input on network meta‐analysis models; contributed to editing and sign‐off of the protocol.

Declarations of interest

IME: this review was supported by a Fundação para a Ciência e a Tecnologia (FCT) Doctoral Scholarship awarded to IME (reference number 2024.02177.BD). IME declares no other commercial or non‐commercial conflicts of interest relevant to this review.

RP: declares no commercial or non‐commercial conflicts of interest relevant to this review.

MPS: declares no commercial or non‐commercial conflicts of interest relevant to this review.

FS: declares no commercial or non‐commercial conflicts of interest relevant to this review.

MRS: declares no commercial or non‐commercial conflicts of interest relevant to this review.

Sources of support

Internal sources

• Internal funding, Other

  No internal sources of support received

External sources

• External funding, Portugal

  This review was supported by a Fundação para a Ciência e a Tecnologia (FCT) Doctoral Scholarship awarded to Inês Martins Esteves (reference number 2024.02177.BD).

Registration and protocol

Cochrane approved the proposal for this review in March 2025. PROSPERO registration: CRD42024601669

Data, code and other materials

Data sharing is not applicable to this article as it is a protocol, so no datasets were generated or analysed.