Effects of tablet-based augmented reality on anxiety, fear, and pain during venipuncture in children: a randomized controlled trial

Abstract

Purpose

This study aimed to evaluate the effects of two different tablet-based augmented reality (AR) applications on anxiety, fear, and pain during venipuncture in children aged 5–12 years.

Design and methods

A prospective, three-arm, parallel randomized controlled trial was conducted in the pediatric blood draw unit of a university hospital. Children were randomly assigned to one of three groups: AR Group A, AR Group B, or usual care (control). Anxiety and fear were assessed before and after venipuncture using the Children’s Anxiety Meter–State and the Child Fear Scale, respectively. Post-procedural pain was assessed using the Wong–Baker Faces Pain Rating Scale. Outcomes were independently reported by children, parents, and nurses. Repeated measures ANOVA and Welch ANOVA were used for statistical analyses.

Results

A total of 120 children (40 per group) were included in the final analysis. Baseline characteristics were comparable across groups. Both AR intervention groups demonstrated significant reductions in anxiety and fear from pre- to post-venipuncture compared with the control group (p < .001). Significant time, group, and time × group effects were observed for both outcomes. Post-procedural pain scores were significantly lower in the AR groups than in the control group across child-, parent-, and nurse-reported assessments (p < .001).

Conclusions

Tablet-based augmented reality interventions effectively reduced anxiety, fear, and pain during venipuncture in children. These findings suggest that AR represents a promising non-pharmacological strategy for managing procedural distress in pediatric nursing practice.

Practice implications

Augmented reality applications delivered via tablet computers can be easily integrated into routine pediatric nursing care and may enhance children’s procedural experiences during venipuncture without disrupting standard clinical workflows.

Trial registration

ClinicalTrials.gov, NCT06575816. Retrospectively registered 16 August 2024.

Supplementary Information

The online version contains supplementary material available at https://doi.org/10.1186/s12887-026-07214-6.

Introduction

Venipuncture is one of the most frequently performed invasive procedures in pediatric healthcare settings and remains a major source of pain, fear, and anxiety for children [15]. Negative experiences during venipuncture have been associated with heightened procedural distress, reduced cooperation, and long-term avoidance of healthcare encounters [2, 26]. For pediatric nurses, managing procedural pain and emotional distress during routine blood draws is therefore a critical component of child-centered care.

Pharmacological approaches to pain management are often impractical or unnecessary for brief procedures such as venipuncture [8, 20]. Consequently, non-pharmacological interventions—particularly distraction-based strategies—are widely recommended in pediatric nursing practice [9, 24]. Evidence suggests that effective distraction can reduce children’s perception of pain and procedural distress by redirecting attention away from noxious stimuli [2, 26]. However, traditional distraction techniques (e.g., toys, videos, verbal reassurance) may be insufficient for some children, especially those with heightened anxiety or prior negative experiences [10, 16].

Advances in digital health technologies have introduced new opportunities to enhance non-pharmacological pain management in pediatric care [1, 13]. Virtual reality has demonstrated effectiveness in reducing pain and anxiety during medical procedures, but its clinical implementation may be limited by cost, equipment requirements, and concerns regarding full sensory isolation in younger children [10, 23]. Augmented reality (AR), which overlays virtual elements onto the real environment, may offer a more feasible alternative in routine clinical settings by maintaining visual contact with the surroundings while providing engaging, interactive content [1, 21].

Despite growing interest in AR-based interventions, empirical evidence regarding their effectiveness during routine pediatric procedures remains limited [21]. In particular, few randomized controlled trials have examined AR interventions implemented by pediatric nurses during venipuncture, and data comparing different AR content types are scarce [1, 21]. Moreover, existing studies often rely on single-informant outcomes, despite evidence that children’s, parents’, and nurses’ perceptions of procedural distress may differ [7, 16].

To address these gaps, the present study aimed to evaluate the effects of two different tablet-based AR applications on anxiety, fear, and pain during venipuncture in children aged 5–12 years. Using a randomized controlled design, the study compared two AR interventions with usual care and assessed outcomes from the perspectives of children, parents, and nurses. By focusing on a practical, low-cost AR approach integrated into routine nursing practice, this study seeks to contribute clinically relevant evidence to support child-centered, non-pharmacological pain management strategies in pediatric nursing [8].

The study is further situated within an internationally recognised rights-based framework. Turkey is a signatory to the United Nations Convention on the Rights of the Child (UNCRC), which enshrines every child's right to receive care that minimises trauma and suffering. The 2023 International Rights-Based Standards for Children and Young People Having Health Care Tests, Treatments, Examinations or Interventions, developed by the ISupport initiative through consultation with clinicians, researchers, parents, and children from 17 countries, operationalise this obligation by mandating the pursuit of the least-traumatic approach to health procedures [4]. The present study is motivated by, and consistent with, these obligations: developing effective, cost-efficient, and least-traumatic approach for routine venipuncture is not merely desirable but closely aligned with contemporary international standards for pediatric care to which Turkey is committed.

Methods

Study design and sample

Participant recruitment and data collection were conducted between April 2024 and December 2024, following ethics approval obtained on 3 April 2024. The study compared two different tablet-based augmented reality (AR) applications with usual care (no AR) during venipuncture in children. The trial was designed and reported in accordance with the CONSORT guidelines for randomized controlled trials [17], and a CONSORT flow diagram summarizes the progress of participants through the trial (Fig. 1).

Fig. 1.

CONSORT flow diagram showing participant recruitment, randomisation, allocation, follow-up, and analysis

Usual care at the participating institution does not include structured distraction techniques; this reflects routine nursing practice at the clinic and was not a purposeful withholding of an intervention for this study. It is also noted that topical anesthesia (e.g., EMLA cream) is not part of routine clinical practice for planned venipuncture at the participating institutions, reflecting the local standard of care and potentially affecting the generalizability of the findings to settings where topical anesthesia is routinely used.

Children aged 5–12 years who were scheduled for routine venipuncture at the study unit were screened for eligibility. This age range was selected because children at this developmental stage are generally able to cooperate with medical procedures and to comprehend the visual self-report rating scales used in the study. Eligible participants were children undergoing routine blood draw whose accompanying parent and themselves agreed to participate, who had sufficient language skills to understand study instructions, and who were able to visually attend to the tablet screen during the procedure. No adverse events related to the AR interventions were observed during the study period.

To ensure that pain assessment reflected venipuncture-related pain only and to minimize potential confounding, children presenting with any concurrent acute pain were excluded. Prior to enrolment, baseline pain was assessed using the Wong–Baker Faces Pain Rating Scale (WBS) by both the child and the accompanying parent. Children who reported any level of pain on the WBS before the procedure, as indicated by either the child or the parent, were not enrolled. In addition, children attending the unit with a painful acute condition (e.g., trauma, acute otalgia, abdominal pain), those requiring analgesic medication for an ongoing pain complaint, as well as children with significant visual impairment that could interfere with viewing the tablet screen or with conditions preventing them from remaining seated during venipuncture, were excluded. Participation was also excluded if either the child or the accompanying parent declined consent.

Following screening, a total of 120 children met the eligibility criteria and were included in the final sample, with 40 children allocated to each study group (AR Group A, AR Group B, and control).

Sample size calculation: Prior to data collection, a power analysis was conducted using G*Power 3.1 [12]. Based on an independent-samples t test for the comparison of mean scores between two groups, with α = 0.05, power = 0.80 and a medium effect size (d = 0.50), the required minimum sample size was calculated as 34 children per group. Considering potential attrition and the three-arm design, we planned to recruit at least 38 children per group. Ultimately, 40 children were included in each group, which increased the precision of the estimates and the power of the study.

Randomization and blinding

A total of 140 children were assessed for eligibility prior to enrolment. Of these, 15 children were excluded, including refusal to participate (n = 8), presence of chronic or genetic diseases (n = 5), and visual problems that could interfere with viewing the tablet screen (n = 2). The remaining 125 children were randomized into the study.

Participants were allocated to one of three groups (AR Group A, AR Group B, or Control) using block randomization stratified by sex (female/male) and age (5–7 years and 8–12 years) to ensure balance across groups. The random allocation sequence was generated in advance using a computer-generated random number table by the principal investigator, who was not involved in outcome assessment.

Allocation concealment was ensured by assigning participants sequentially according to the pre-generated randomization list after eligibility confirmation and completion of baseline assessments. Group assignments were not accessible to the outcome assessors or data analysts.

During the intervention period, 5 children were excluded from the final analysis primarily due to distress or unwillingness to continue the AR intervention; the blood draw was completed under usual care conditions in all cases. Post-procedure data for these participants were not retained, as the intervention was terminated mid-procedure rendering their outcomes incomparable to full-intervention completers under the pre-specified complete-case analysis approach. The final study sample consisted of 120 children, with 40 children allocated to each group (Fig. 1).

Blinding

Because the intervention involved the visible use of tablet-based augmented reality applications, complete blinding of participants to the presence of an intervention was not feasible. However, children, parents, and nurses were not informed that two different AR intervention types existed, nor were they informed of the study hypotheses. Thus, blinding to intervention classification and comparative purpose was maintained.

The AR Group A intervention was implemented by Researcher I, and the AR Group B intervention was implemented by Researcher R. These researchers were not involved in outcome measurement.

Outcome assessment and data handling were conducted under blinded conditions as follows:

• Data coding was performed by Researcher Z,

• Statistical analyses were conducted by Researcher M,

Both researchers were fully blinded to group allocation.

This strict separation of roles ensured minimization of performance bias, detection bias, and analytic bias in full accordance with CONSORT recommendations.

Due to the nature of the intervention, children were aware that they were watching a tablet-based application; however, they were not informed about the comparative purpose or group labels of the study. Parents and nurses were not informed about the specific AR content assigned to each group. Thus, all were blinded to intervention classification and study hypotheses.

Instruments

Demographic form

A researcher-developed sociodemographic form was used to collect information on the child’s age, sex, last blood draw time, and the success of the blood draw.

Children’s anxiety meter – state

Children’s state anxiety was assessed using the Children’s Anxiety Meter – State (CAM-S), a visual analogue instrument designed to evaluate children’s anxiety in clinical settings and prior to medical procedures. The CAM resembles a thermometer with a bulb at the bottom and horizontal interval lines extending upward. Children are asked to mark how they feel “right now” on the scale to indicate their current level of anxiety [14]. Scores range from 0 (no anxiety) to 10 (highest possible anxiety).

The CAM-S was originally validated for children aged 4–10 years during intravenous procedures and demonstrated significant associations with all parent-reported anxiety measures as well as observed distress ratings [11].

The Turkish psychometric evaluation of the CAM-S was performed by Gerçeker, Binay, Bilsin, Kahraman, and Yılmaz (2018), who identified a significant negative correlation between children’s anxiety scores and age, supporting its construct validity in Turkish pediatric samples.

Child fear scale

Fear related to venipuncture was assessed using the Child Fear Scale (CFS), a one-item self-report instrument consisting of five sex-neutral facial expressions. The scale ranges from a neutral face indicating no fear (0) on the far left to a face representing extreme fear (4) on the far right, with the selected facial expression reflecting the child’s perceived level of fear. The CFS is suitable for use by children, parents and researchers and can be administered before and during medical procedures in children aged 5–10 years [16].

The CFS was developed based on the Faces Anxiety Scale for adults (McKinley & Madronio, 2008); however, the wording and instructions were developmentally adapted to align with children’s fear-related language capacity. Initial psychometric evaluation of the CFS demonstrated high concurrent convergent validity with another self-report measure of fear and moderate discriminant validity with child coping and child distress behaviors [16].

The Turkish psychometric validation of the CFS was conducted by Gerçeker, Ayar, Özdemir, and Bektaş (2018), who reported a significant negative correlation between children’s fear scores and age, indicating that younger children exhibited higher fear levels.

Wong–baker faces pain rating scale

Procedural pain was assessed using the Wong–Baker Faces Pain Rating Scale (WBS). The scale consists of six facial expressions representing increasing levels of pain intensity, ranging from 0 (no pain) to 10 (worst pain). The WBS is widely used for pain assessment in children aged 3 years and older and allows children to self-report pain in a simple and developmentally appropriate manner. [27].

In addition to child self-report, the WBS was also completed independently by the accompanying parent and the nurse who performed the venipuncture, providing multi-informant assessment of procedural pain. The WBS has demonstrated robust psychometric properties and has been widely used in the Turkish pediatric population.

Data collection and intervention procedure

Data collection was conducted in the pediatric blood draw unit of the university hospital by the principal investigator and trained research assistants. Children scheduled for routine venipuncture and their accompanying parents were approached in the waiting area prior to the procedure. After verification of eligibility criteria, written informed consent was obtained from parents and verbal assent from children.

Baseline assessment

Before venipuncture, baseline measurements were completed in the waiting area. Children independently rated their fear and anxiety using the Child Fear Scale (CFS) and the Children’s Anxiety Meter–State (CAM-S). Parents completed the same instruments independently based on their observations, without access to the child’s responses.

Procedural and post-procedural assessment

All venipuncture procedures were performed in the pediatric blood draw unit, which consisted of individual blood collection cabins staffed by experienced pediatric nurses. Each child entered the cabin accompanied by one parent. Upon arrival, the nurse confirmed the child’s identity and positioned the child in the blood draw chair, while the parent was seated next to the child.

Before initiating venipuncture, the nurse introduced the materials to be used and asked the child to indicate the preferred arm. Following the child’s verbal assent, venipuncture was performed using a disposable vacuum collection system. If the first attempt was unsuccessful, a second attempt was made using the contralateral arm. In cases where the child was unwilling to proceed immediately, the procedure was temporarily postponed and resumed only when the child indicated readiness.

To ensure procedural consistency, all nurses followed a standardized verbal protocol throughout the study. Venipuncture success was defined as the initiation of blood flow into the collection tube within 5 s following needle insertion.

Children allocated to the intervention groups received tablet-based augmented reality (AR) applications during venipuncture. The AR intervention for Group A was implemented by Researcher I, and the intervention for Group B was implemented by Researcher R.

Before the procedure, children were introduced to the tablet and informed that they could continue watching the AR content throughout venipuncture. To minimize interference with the procedure, venipuncture was preferentially performed on the non-dominant arm. The tablet device was disinfected with an antiseptic wipe before each use in accordance with institutional infection control protocols. The tablet was held by the research assistant and positioned approximately 30–40 cm from the child's face, within their direct and unobstructed field of vision throughout the procedure.

The AR applications were selected by the research team in accordance with the study aims.

• AR Group A viewed a highly stimulating application featuring colorful, fast-moving three-dimensional objects and characters designed to capture attention.

• AR Group B viewed a calming application featuring slower-paced movements and visually soothing scenes designed to promote relaxation. AR Group A application: high interactivity, fast movement speed, high sensory load, designed to maximally capture and hold attention through active engagement. AR Group B application: low interactivity, slow movement speed, low sensory load, designed to promote relaxation through passive, soothing visual stimulation. Both applications superimposed animated three-dimensional content onto the real environment as perceived through the tablet camera, preserving the child's awareness of their physical surroundings throughout.

Both applications were pilot-tested prior to the main study in a group of 10 children aged 5–12 years. No adverse reactions were reported, and the content was deemed age-appropriate and engaging.

If a child requested discontinuation of the AR application during the procedure, the venipuncture was immediately paused, the AR intervention was terminated, and the blood draw was completed under usual care conditions. These cases were documented and excluded from the relevant analyses if outcome data were incomplete.

Control group

Children in the control group received usual care only during venipuncture and were not exposed to any distraction technique. They were informed that no additional intervention would be applied and that they would be observed during the blood draw if they agreed to participate. Usual care at the participating institutions consists of routine nursing care without any structured distraction technique. No distraction was purposefully withheld from the control group; structured distraction is simply not part of routine nursing practice at these clinical sites.

Post-procedure assessment

Immediately after completion of the venipuncture, children independently rated:

• pain using the Wong–Baker Faces Pain Rating Scale (WBS),

• fear using the Child Fear Scale (CFS), and

• anxiety using the Children’s Anxiety Meter–State (CAM-S).

Parents subsequently completed the same post-procedure scales independently based on their observations. After the child and parent exited the cabin, the nurse who performed the venipuncture independently rated the child’s pain using the WBS.

Ethics

Ethics approval for this study was obtained from the Dokuz Eylul University Non-Interventional Clinical Research Ethics Committee (Approval No: 2024/13-09, Date: 3 April 2024). The study was conducted in accordance with the Declaration of Helsinki. Institutional permission was granted to conduct the study in the pediatric blood draw unit. Participation was voluntary, and children and parents were informed that they could withdraw at any time without affecting their care. Written informed consent was obtained from all parents or legal guardians, and verbal assent was obtained from children.

Clinical trial registration

Clinical trial registration: ClinicalTrials.gov (Identifier: NCT06575816; retrospectively registered on 16 August 2024).

Funding

This research received no external funding.

Data analysis

Data were analyzed using IBM SPSS Statistics version 29.0 (IBM Corp., Armonk, NY, USA). All statistical tests were two-tailed and a p value of < 0.05 was considered statistically significant. Categorical variables were summarized as frequencies and percentages, and continuous variables were presented as means and standard deviations.

The normality of continuous outcome variables (fear, anxiety, and pain scores) was assessed using the Kolmogorov–Smirnov test together with visual inspection of histograms, Q–Q plots, and skewness–kurtosis values. Homogeneity of variances was evaluated using Levene’s test. Baseline demographic and clinical characteristics were compared across the three groups using chi-square tests for categorical variables and one-way ANOVA or Kruskal–Wallis tests for continuous variables, as appropriate. These analyses confirmed baseline comparability between groups prior to intervention.

To evaluate the effects of the AR interventions on fear and anxiety, mixed-design repeated measures ANOVA was conducted separately for child-reported, parent-reported, and nurse-reported outcomes, with time (pre- vs. post-procedure) as the within-subject factor and group (AR Group A, AR Group B, control) as the between-subject factor. The group × time interaction was considered the primary indicator of intervention effectiveness. When significant main or interaction effects were detected, Bonferroni-adjusted post hoc comparisons were performed. In addition, paired-samples t tests were used within each group to examine pre–post changes in fear and anxiety, in accordance with the reporting format of the tables.

Post-procedural pain scores assessed using the Wong–Baker Faces Pain Rating Scale (WBS) were compared between the three groups separately for child, parent, and nurse reports. Due to violation of the assumption of homogeneity of variances, one-way ANOVA with Welch correction was applied.

Participants with incomplete outcome measurements or who discontinued the intervention were excluded from the corresponding analyses using a complete case analysis approach. The number of excluded participants and reasons for exclusion are presented in the CONSORT flow diagram.

Results

Sample characteristics

A total of 120 children were included in the final analysis, with 40 participants allocated to each study group (AR Group A, AR Group B, and control). The mean age and sex distribution were comparable across groups, with no statistically significant differences observed (p > 0.05).

Baseline procedural characteristics were also balanced. The time since the child’s previous venipuncture and the proportion of children with prior venipuncture experience did not differ significantly among the three groups (p > 0.05). Overall, no significant differences were identified in sociodemographic or baseline clinical characteristics, indicating successful randomisation and baseline equivalence of the study groups (Table 1).

Table 1.

Baseline Characteristics of Children by Study Group (n = 120)

Variable	AR Group A (n = 40)	AR Group B (n = 40)	Control Group (n = 40)	Test	p
Age (years), Mean ± SD	8.25 ± 2.31	8.40 ± 2.18	8.50 ± 2.29	F = 0.79	.457
Female, n (%)	20 (50.0)	20 (50.0)	20 (50.0)	χ2 = 0.00	1.00
Male, n (%)	20 (50.0)	20 (50.0)	20 (50.0)
Time since last venipuncture				χ2 = 1.02	.600
< 1 month n (%)	13 (32.5)	14 (35.0)	13 (32.5)
1–6 months n (%)	14 (35.0)	13 (32.5)	14 (35.0)
> 6 months n (%)	13 (32.5)	13 (32.5)	13 (32.5)

Anxiety and fear outcomes

Anxiety (Children’s Anxiety Meter–State)

Anxiety levels assessed using the Children’s Anxiety Meter–State (CAM-S) showed significant differences over time between the study groups. Repeated measures ANOVA revealed significant main effects of time and group, as well as a significant time × group interaction (all p < 0.001), indicating that changes in anxiety levels from pre- to post-venipuncture differed across groups.

Baseline anxiety scores were comparable among AR Group A, AR Group B, and the control group (p > 0.05). Following venipuncture, both AR intervention groups demonstrated substantial reductions in anxiety scores, whereas anxiety levels in the control group remained largely unchanged. Within-group analyses confirmed significant pre–post reductions in anxiety in AR Group A and AR Group B (both p < 0.001), while no significant change was observed in the control group (p > 0.05). Post-intervention anxiety scores were significantly lower in both AR groups compared with the control group across child-, parent-, and nurse-reported assessments (Tables 2, 3 and 4).

Table 2.

Nurse-Reported Anxiety, Fear, and Pain Scores Before and After Venipuncture (n = 120)

Anxiety (CAM-S)				F	p
	AR Group A (n = 40)	AR Group B (n = 40)	Control Group (n = 40)
Pre-intervention, M ± SD	4.40 ± 2.36	4.60 ± 2.18	4.83 ± 2.33
Post-intervention, M ± SD	0.33 ± 1.24	0.60 ± 1.80	4.30 ± 2.15
Within-group change, t	12.69	9.12	1.01
p	< 0.001	< 0.001	0.31
Time				131.89	<.001
Group				24.97	<.001
Time × Group				22.01	<.001
Fear (CFS)
Pre-intervention, M ± SD	1.83 ± 1.10	2.17 ± 1.03	2.03 ± 1.09
Post-intervention, M ± SD	.10 ±.37	.23 ±.73	1.98 ±.30
Within-group change, t	11.35	9.63	.20
p	< 0.001	< 0.001	.843
Time				109.44	<.001
Group				24.87	<.001
Time × Group				25.50	<.001
Pain (WBS, post-procedure only)
Post-procedure, M ± SD	0.85 ± 1.42	0.90 ± 1.97	4.88 ± 2.63

Welch ANOVA: F = 38.52, p <.001

Table 3.

Child-reported anxiety, fear and pain scores before and after venipuncture by group (n = 120)

Anxiety (CAM-S)
	AR Group A (n = 40)	AR Group B (n = 40)	Control Group (n = 40)
Pre-intervention, M ± SD	4.22 ± 2.37	4.35 ± 2.15	4.05 ± 2.53
Post-intervention, M ± SD	0.35 ± 1.16	0.45 ± 1.61	3.98 ± 2.37
Within-group change, t	12.01	9.38	0.12
p	< 0.001	< 0.001	0.89
Time			99.64 <.001
Group			16.09 <.001
Time × Group			23.50 <.001
Fear (CFS)
Pre-intervention, M ± SD	1.53 ± 1.24	0.70 ± 1.20	1.45 ± 1.15
Post-intervention, M ± SD	0.13 ± 0.40	0.20 ± 0.72	1.60 ± 1.23
Within-group change, t	8.01	6.62	0.47
p	< 0.001	< 0.001	0.641
Time			41.14 <.001
Group			11.27. <.001
Time × Group			13.89 <.001
Pain (WBS, post-procedure only)
Post-procedure, M ± SD	0.65 ± 1.38	0.70 ± 1.78	4.78 ± 2.54

Welch ANOVA: F = 43.48, p <.001

Table 4.

Parent-reported anxiety, fear and pain scores before and after venipuncture by group (n = 120)

Anxiety (CAM-S)
	AR Group A (n = 40)	AR Group B (n = 40)	Control Group (n = 40)
Pre-intervention, M ± SD	4.65 ± 2.41	4.50 ± 2.01	4.88 ± 2.17
Post-intervention, M ± SD	0.35 ± 1.16	0.58 ± 1.73	4.43 ± 2.21
Within-group change, t	12.86	9.94	0.88
p	< 0.001	< 0.001	0.38
Time			142.98 <.001
Group			27.12 <.001
Time × Group			25.68. <.001
Fear (CFS)
Pre-intervention, M ± SD	1.70 ± 1.26	2.05 ± 1.10	1.78 ± 1.20
Post-intervention, M ± SD	0.08 ± 0.26	0.23 ± 0.76	1.70 ± 1.12
Within-group change, t	8.95	9.83	0.00
p	< 0.001	< 0.001	1.00
Time			83.20 <.001
Group			15.26 <.001
Time × Group			21.01 <.001
Pain (WBS, post-procedure only)
Post-procedure, M ± SD	0.73 ± 1.50	0.85 ± 1.86	5.03 ± 2.75

Welch ANOVA: F = 40.16, p <.001

Fear (Child Fear Scale)

Fear related to venipuncture, measured using the Child Fear Scale (CFS), followed a pattern consistent with anxiety outcomes. Repeated measures ANOVA indicated significant main effects of time and group, as well as a significant time × group interaction (all p < 0.001), demonstrating differential changes in fear levels across the three groups.

Baseline fear scores did not differ significantly between groups (p > 0.05). After the venipuncture procedure, fear scores decreased significantly in both AR intervention groups, whereas no significant change was observed in the control group. Within-group analyses confirmed significant reductions in fear scores in AR Group A and AR Group B (both p < 0.001), while the control group showed no significant within-group change (p > 0.05). Post-procedural fear scores were significantly lower in the AR groups compared with the control group across child-, parent-, and nurse-reported evaluations (Tables 2, 3, and 4).

Pain outcomes

Post-procedural pain was assessed once, immediately after venipuncture, using the Wong–Baker Faces Pain Rating Scale (WBS). As pain was measured at a single time point, between-group comparisons were conducted for post-procedure scores only.

Across all reporters, post-procedural pain scores differed significantly among the three study groups. Welch’s ANOVA, applied due to heterogeneity of variances, demonstrated a significant overall group effect for child-reported pain (F = 43.48, p < 0.001) (Table 3), nurse-reported pain (F = 38.52, p < 0.001) (Table 2), and parent-reported pain (F = 40.16, p < 0.001) (Table 4).

Children in both AR intervention groups reported substantially lower pain scores compared with children in the control group. Parent- and nurse-reported pain ratings showed consistent patterns, with lower post-procedural pain observed in AR Group A and AR Group B relative to the control group. No pre-procedural pain comparison was performed, as children reporting any baseline pain were excluded to isolate pain specifically attributable to the venipuncture procedure.

Discussion

The present randomized controlled trial provides evidence that tablet-based augmented reality interventions are effective in reducing anxiety, fear, and pain during venipuncture in children aged 5–12 years. Compared with usual care, both AR interventions resulted in substantial pre- to post-procedural reductions in anxiety and fear, as well as markedly lower post-procedural pain scores. These effects were consistently observed across child-, parent-, and nurse-reported outcomes (Tables 2, 3 and 4), supporting the robustness of the findings and reducing the likelihood that the results were driven by single-informant bias.

Importantly, baseline characteristics and baseline levels of anxiety and fear were comparable across the three groups (Table 1), indicating successful randomization and strengthening causal inference regarding the effects of the AR interventions. In contrast to the pronounced improvements observed in both AR groups, no meaningful changes were detected in the control group, underscoring the added value of AR-based distraction beyond routine care during venipuncture.

The finding that anxiety and fear scores in the control group showed no significant change from pre- to post-venipuncture warrants interpretation. Two explanations are plausible. First, a ceiling effect may have been operative: baseline anxiety and fear scores in the control group were already elevated prior to the procedure, leaving limited room for further increase. Second, the consistent presence of a parent throughout the procedure may have provided a fundamental sense of security that partially buffered procedural distress, a phenomenon documented in the paediatric procedural pain literature. The current study design does not allow these mechanisms to be disentangled, and future research should examine the independent and combined contributions of parental presence and baseline distress levels to procedural outcomes in the control condition.

Clinical magnitude and practical significance of the effects

Beyond statistical significance, the magnitude of the observed effects suggests clear clinical relevance. Across all informants, anxiety scores measured using the Children’s Anxiety Meter–State decreased from moderate pre-procedural levels to values approaching the lower end of the scale following AR exposure (Tables 2, 3, and 4). Similarly, fear scores assessed with the Child Fear Scale declined to near-zero levels in both AR groups, while remaining largely unchanged in the control group. Post-procedural pain scores measured using the Wong–Baker Faces Pain Rating Scale were also markedly lower in the AR groups, with mean scores below 1, compared with scores around 5 in the control group (Tables 2, 3, and 4).

Such reductions are likely to be meaningful in routine pediatric practice [8]. Venipuncture is a brief but highly distressing procedure for many children and parents, and even modest reductions in anxiety, fear, and pain can substantially improve cooperation, procedural efficiency, and the overall care experience [2, 3, 5]. The very low levels, unlikely to interfere with routine care, observed in the AR groups indicate that tablet-based AR may be sufficient to minimize procedural distress to clinically negligible levels for many children, without the need for pharmacological analgesia or more complex interventions [6, 9].

Why stimulating and calming AR produced similar effects

Although the two AR applications were intentionally designed to differ in arousal profile—one providing stimulating, fast-moving visual content and the other offering calming, slow-paced scenes—both interventions produced highly similar reductions in anxiety, fear, and pain (Tables 2, 3 and 4). This finding suggests that, in the context of venipuncture, the presence of effective distraction itself may be more critical than the specific emotional tone of the content [2, 5].

One plausible explanation is that venipuncture is a short-duration procedure, during which rapid attentional capture is paramount. By redirecting children’s attention away from threat-related cues such as anticipation of needle insertion and sensory monitoring of the procedure, both AR applications may have successfully interrupted pain- and fear-related cognitive processing, regardless of whether the content was stimulating or calming [9, 10]. Once attention is effectively diverted, additional modulation of arousal level may confer limited incremental benefit.

Furthermore, post-intervention scores in both AR groups approached the lower bounds of the anxiety and fear scales (Tables 2, 3 and 4), suggesting a potential floor effect. When distress is already reduced to very low levels, meaningful differentiation between content types may be difficult to detect. This interpretation aligns with recent evidence indicating that while technology-based distraction reliably reduces needle-related pain and distress in children, differences between specific content styles or system characteristics are not always observed when engagement is sufficient [6, 15].

Comparison with existing literature

The present findings are broadly consistent with a growing body of literature demonstrating that technology-based distraction, including immersive virtual reality and digital applications, can reduce procedural pain, fear, and anxiety in pediatric populations. Recent systematic reviews and meta-analyses have shown that both immersive and non-immersive digital distraction modalities are associated with significant reductions in needle-related distress compared with usual care, although the magnitude of effects varies across studies and procedural contexts [6, 19]. The reductions observed in the current study across anxiety, fear, and pain outcomes (Tables 2, 3 and 4) align with these findings and further support the effectiveness of distraction-based interventions during venipuncture.

However, most prior studies have focused on fully immersive virtual reality systems that require head-mounted displays and specialized equipment [21]. While effective, such systems may be associated with higher costs, technical complexity, and concerns related to sensory isolation, particularly in younger children or in fast-paced clinical environments [10, 26]. In contrast, the present study demonstrates that tablet-based augmented reality, which allows children to remain visually connected to their surroundings while engaging with virtual content, can achieve comparable reductions in procedural distress. This finding extends previous work by suggesting that full immersion may not be necessary to obtain clinically meaningful benefits, particularly for brief procedures such as venipuncture [15].

Moreover, the current study contributes novel evidence by directly comparing two different AR content profiles within a randomized controlled design. Existing reviews have highlighted the heterogeneity of digital distraction content and the limited examination of content-specific effects [15, 21]. By showing that both stimulating and calming AR applications were similarly effective (Tables 2, 3 and 4), the present findings suggest that engagement and attentional capture, rather than specific emotional tone, may be the primary determinants of effectiveness in this context. This insight helps to clarify mixed findings in the literature regarding the superiority of particular digital formats or content styles and supports a more pragmatic approach to AR selection in clinical practice [5, 19].

Value of multi-informant assessment

A notable strength of the present study is the use of multi-informant outcome assessment, incorporating reports from children, parents, and nurses. Across all three informants, AR interventions were associated with consistent and substantial reductions in anxiety, fear, and pain compared with usual care (Tables 2, 3 and 4). This convergence of perspectives strengthens the internal validity of the findings and reduces the likelihood that the observed effects reflect reporting bias or informant-specific perceptions.

Previous research has demonstrated that assessments of procedural distress may vary depending on the informant, with discrepancies often observed between children’s self-reports and adult proxy reports [2, 22]. Such differences can complicate interpretation when outcomes rely on a single informant [18, 25]. By capturing child-reported experiences alongside parent observations and nurse assessments, the present study provides a more comprehensive and clinically meaningful evaluation of procedural distress [25]. The alignment of findings across informants in this trial suggests that the benefits of AR-based distraction were not only subjectively perceived by children but were also observable to caregivers and healthcare professionals.

From a clinical perspective, this multi-informant approach is particularly relevant in pediatric nursing practice. Nurses’ assessments of pain and distress directly inform procedural decision-making and care strategies, while parental perceptions influence family satisfaction and acceptance of interventions. The consistency observed across informants in the current study therefore enhances confidence in the applicability of the findings to real-world clinical settings. Taken together, these results underscore the value of incorporating multiple perspectives when evaluating non-pharmacological pain management interventions and support the use of AR as a credible, observable, and child-centered strategy during routine venipuncture. Together, these findings highlight the importance of multi-informant assessment in pediatric procedural research and reinforce the credibility of AR-based interventions as observable and clinically meaningful nursing strategies.

Implications for pediatric nursing practice

The findings of this study have direct implications for pediatric nursing practice, particularly in settings where venipuncture and other brief invasive procedures are routinely performed. The substantial reductions in anxiety, fear, and pain observed in both AR intervention groups (Tables 2, 3 and 4) indicate that tablet-based augmented reality can serve as an effective, non-pharmacological strategy to improve children’s procedural experiences. Importantly, these benefits were achieved without complex equipment, highlighting the practicality of AR integration into everyday nursing care.

From a nursing perspective, the use of tablet-based AR offers several advantages. The intervention is easy to implement, requires minimal training, and does not disrupt routine clinical workflows. Because children remain visually connected to their environment, communication between the nurse, child, and parent is preserved, which is particularly important for establishing trust and cooperation during procedures. The observed consistency of effects across child-, parent-, and nurse-reported outcomes further suggests that AR-based distraction not only improves children’s subjective experiences but also facilitates smoother and more manageable procedures from the nurse’s standpoint.

Given the time constraints and high patient turnover typical of pediatric blood draw units, the effectiveness of a brief, low-cost, and nurse-led intervention is especially relevant. The present findings support the incorporation of tablet-based AR as a child-centered adjunct to usual care, offering pediatric nurses a feasible tool to reduce procedural distress and enhance the quality of care during venipuncture. It is also worth noting that child satisfaction is an outcome in its own right within a rights-based framework: children's positive procedural experiences are likely to influence family satisfaction, future healthcare engagement, and willingness to comply with medical procedures, underscoring the broader value of least-traumatic approaches beyond the immediate clinical encounter.

Strengths

This study has several notable strengths. First, the randomized controlled design with three parallel arms strengthens causal inference regarding the effects of AR interventions. Second, the inclusion of two distinct AR content types allowed for an examination of whether content characteristics influenced outcomes, addressing a gap in the existing literature. Third, the use of multi-informant assessment—including child, parent, and nurse reports—enhanced the internal validity of the findings and provided a comprehensive evaluation of procedural distress. Finally, the study focused on a practical, tablet-based AR approach that is readily applicable in real-world clinical settings.

Limitations

Several limitations should also be considered. The study was conducted at a single center, which may limit generalizability to other clinical contexts or healthcare systems. However, the standardized nature of venipuncture procedures may partially mitigate this limitation. Outcomes were assessed immediately before and after venipuncture; therefore, the durability of the observed effects over repeated procedures or longer follow-up periods could not be evaluated. In addition, although two different AR content profiles were compared, the study did not assess individual child preferences, engagement levels, or physiological indicators of arousal, which may have provided further insight into the mechanisms underlying the intervention effects. Finally, complete blinding of participants was not feasible due to the visible nature of the intervention, although efforts were made to minimize bias through role separation and blinded outcome assessment. Furthermore, topical anesthesia (e.g., EMLA cream) is not part of usual care at the participating institution; this may limit generalizability to settings where topical anesthesia is routinely used, as the baseline pain experience in those settings differs from the present sample. The absence of structured distraction in the usual care condition means the study demonstrates AR's effectiveness relative to an undistracted control, rather than relative to currently optimized practice; future studies should compare AR against established distraction techniques. The exclusion criteria limited participation to children without neurodevelopmental conditions, sensory impairments, chronic illness, or concurrent injury; findings cannot be generalized to these populations, who may exhibit distinct distress profiles and differential responses to AR. As this was a single-exposure study, it remains unknown whether repeated use of the same AR content would produce diminishing returns due to a novelty effect. In addition, frequency of prior venipuncture was not analyzed as a subgroup variable, which precludes conclusions about whether habituation or sensitization to the procedure moderates response to AR-based distraction.

Future research directions

Future research should build on the present findings in several ways. Multicenter trials involving more diverse clinical settings would help to confirm the generalizability of tablet-based AR interventions in pediatric care. Longitudinal studies examining repeated venipuncture experiences could determine whether AR not only reduces immediate distress but also mitigates anticipatory anxiety and fear associated with future procedures.

Further investigation into content-specific and child-specific factors is also warranted. Studies incorporating measures of engagement, preference, or physiological arousal may clarify whether certain children benefit more from stimulating versus calming content, or whether personalization enhances effectiveness. Additionally, extending AR interventions to longer or more complex procedures may help to determine whether content differences become more salient as procedural duration increases.

Finally, future work should explore implementation outcomes relevant to nursing practice, such as feasibility, acceptability, cost-effectiveness, and impact on workflow. Such research would provide valuable evidence to support the broader adoption of augmented reality as a routine, non-pharmacological pain management strategy in pediatric nursing.

Abbreviations

AR

Augmented reality

CAM-S

Children’s Anxiety Meter–State

CFS

Child Fear Scale

WBS

Wong–Baker Faces Pain Rating Scale

Authors’ contributions

EZO conceived and designed the study, supervised data collection, performed the analysis, and drafted the manuscript. INÖ and RÇ contributed to data collection and manuscript revision. MB contributed to study design and critically revised the manuscript. All authors read and approved the final manuscript.

Funding

This research received no external funding.

Data availability

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

Declarations

Ethics approval and consent to participate

Ethics approval for this study was obtained from the Dokuz Eylul University Non-Interventional Clinical Research Ethics Committee (Approval No: 2024/13-09, Date: 3 April 2024). The study was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from parents or legal guardians, and verbal assent was obtained from children.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.