Effect of systemic counselling on anxiety and childbirth self-efficacy among first-time mothers: a randomised controlled trial protocol in prenatal healthcare centres of Babol, Iran

Abstract

Introduction

Pregnancy and childbirth are transformative experiences that can provoke anxiety, potentially reducing women’s confidence and satisfaction with the process. Systemic counselling, which considers family and interpersonal dynamics, may alleviate anxiety, enhance self-efficacy and improve satisfaction with childbirth. Addressing these psychological and relational factors is crucial for maternal and neonatal well-being.

Methods and analysis

This parallel-group randomised controlled trial will involve 72 primiparous pregnant women in Babol, Iran. Eligible participants will be randomly assigned to either the intervention or control group using permuted block randomisation with a block size of four. The intervention group will receive six structured 90-minute sessions, including one in-person and five online group sessions (6–10 participants per session) delivered via WhatsApp. The sessions follow a Bowen systemic counselling approach targeting family and social dynamics. The primary outcomes are anxiety reduction, enhanced childbirth self-efficacy and improved satisfaction with childbirth. The target sample size is 72 participants (36 per group). Participant enrolment began in November 2025 and is currently ongoing. Data will be analysed using both the full analysis set (FAS) and per-protocol set (PPS). The trial is currently ongoing and is expected to be completed by July 2026.

Ethics and dissemination

The study was approved by the Ethics Committee of Babol University of Medical Sciences (IR.MUBABOL.HRI.REC.1404.070). The sponsor is Babol University of Medical Sciences. No external funding was received. Results will be disseminated through peer-reviewed journals and scientific conferences.

Trial registration

IRCT20100510003902N7.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This study focuses on primiparous pregnant women, a key population for preventive psychological interventions.

• It uses a structured Bowen systemic counselling programme combining in-person and virtual group sessions, which enhances accessibility and engagement.

• It employs validated instruments (Pregnancy-Related Anxiety Questionnaire-17, Childbirth Self-Efficacy Inventory and satisfaction questionnaire) for outcome assessment.

• Blinding was not feasible due to the nature of the intervention, and the lack of long-term follow-up limits generalisability.

Introduction

Pregnancy is a natural yet complex process marked by profound physiological and psychological transformations that can influence women’s daily functioning and emotional well-being.^{1 2} These changes, combined with the anticipation of motherhood, may heighten vulnerability to anxiety and reduce confidence in managing childbirth.³

Childbirth satisfaction is widely recognised as an important indicator of both maternal health and the quality of maternity care services.^{4 5} A positive birth experience enhances psychological well-being, strengthens the mother–infant bond, and reduces the risk of postpartum depression.⁴ Focusing on women’s needs and preferences during pregnancy and childbirth—while providing accurate information and a supportive environment—significantly improves satisfaction and overall outcomes.^{5 6}

Self-efficacy, introduced by Albert Bandura, refers to one’s belief in one’s ability to perform specific tasks or manage challenges effectively.⁷ During pregnancy and childbirth, self-efficacy determines how women perceive, prepare for, and cope with labour and delivery. Higher levels of childbirth self-efficacy are associated with lower anxiety, better pain management and greater satisfaction with the birthing experience.^{8 9} Factors such as prenatal education, previous experiences, social support and the healthcare environment play essential roles in shaping this sense of efficacy.¹⁰

Psychological and educational interventions have demonstrated positive effects in reducing anxiety and improving self-efficacy and childbirth satisfaction among pregnant women.^{11 12} Prenatal education increases knowledge and confidence regarding labour, while psychological counselling assists in emotional regulation and managing fear.^{13 14} Moreover, supportive family and social environments enhance women’s sense of safety, control and empowerment during childbirth.¹⁵

Systemic counselling is a modern psychological approach rooted in systems theory and family therapy, focusing on the interactions among individuals and their social environments.^{16 17} It emphasises that individual emotions and behaviours are influenced by communication patterns, boundaries and roles within family systems.¹⁸ This approach uses techniques such as circular questioning, scaling and behavioural assignments to improve communication and relational awareness.^{19 20}

Bowen’s family systems theory, a key framework within systemic counselling, highlights core concepts such as self-differentiation, triangulation, emotional cut-off, multigenerational transmission, sibling position and chronic family anxiety.²¹ These principles explain how emotional patterns are transmitted across generations and influence present behaviours and relationships.²² Bowen’s systemic approach in counselling helps individuals improve emotional regulation, empathy and relational functioning.²⁰

Given the family-oriented cultural context of Iran, where collective relationships and intergenerational dynamics strongly influence individual experiences, Bowen’s systemic counselling could be particularly effective for pregnant women. It can strengthen social support, reduce tension, enhance self-awareness and promote healthier family communication patterns. This, in turn, may increase self-efficacy and satisfaction with childbirth.²³

Previous research has demonstrated the positive effects of various counselling interventions on pregnancy-related outcomes. Regarding anxiety, randomised controlled trials have shown that psychological counselling, including stress management and positive psychology approaches, significantly reduces anxiety levels during pregnancy and the postpartum period.24,26 Concerning childbirth self-efficacy, prenatal counselling and educational programmes have been found to enhance women’s confidence in their ability to cope with labour and delivery. For example, supportive counselling and stress management counselling have been shown to significantly improve maternal self-efficacy.27,29 Additionally, childbirth satisfaction is improved by emotional support and continuous counselling throughout pregnancy, as evidenced by multiple studies showing that supportive counselling enhances maternal psychological well-being and birth experiences.30,32 For instance, a recent randomised controlled trial in Iran demonstrated that mindfulness-based counselling significantly enhanced childbirth satisfaction among primiparous women³²

However, most existing interventions have focused on general counselling approaches (such as cognitive-behavioural therapy or routine supportive counselling) rather than systemic counselling grounded in family systems theory. Bowen’s systemic approach, which addresses multigenerational patterns, emotional regulation and family communication, has not been previously examined in the context of perinatal care. Given the family-oriented cultural context of Iran, where collective relationships and intergenerational dynamics strongly shape individual experiences, Bowen’s systemic counselling may be particularly effective for primiparous women. To date, no randomised controlled trial has evaluated the effectiveness of a Bowen-based systemic counselling programme on anxiety, self-efficacy and childbirth satisfaction among primiparous mothers in Iran. Therefore, this study aims to evaluate the effectiveness of systemic counselling based on Bowen’s approach on anxiety, self-efficacy and childbirth satisfaction in primiparous pregnant women.

Methods and analysis

Patient and public involvement

No patient or public involvement occurred in the design, conduct, reporting or dissemination plans of this research.

Study design

This study is a parallel-group, randomised controlled trial designed to evaluate the effect of systemic counselling using a Bowenian approach on pregnancy-related anxiety, self-efficacy and childbirth satisfaction among primiparous women. The study was conceived within a superiority framework, hypothesising that participants in the counselling group would demonstrate higher levels of childbirth satisfaction and self-efficacy, as well as lower levels of pregnancy-related anxiety, compared with those receiving usual care.

The study protocol was developed in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines and is presented following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (see figure 1). The study received approval from the Ethics Committee of Babol University of Medical Sciences (IR.MUBABOL.HRI.REC.1404.070). The results will be disseminated through peer-reviewed journals and scientific conferences. The trial is registered with the Iranian Registry of Clinical Trials (IRCT20100510003902N7) and was prospectively registered on September 14, 2025.

Figure 1. SPIRIT-style schedule of enrolment, interventions and assessments. The figure presents the planned schedule of enrolment, allocation, intervention and assessments across the study period. Participants will be screened for eligibility, invited and will provide informed consent at the enrolment phase (−t₁), followed by baseline assessment (t₀) and randomisation. The intervention group will receive Bowen systemic counselling during weeks 1–6, while the control group will receive routine care. Assessments will be conducted at specified time points, including baseline and post-intervention periods. Measured outcomes will include sociodemographic and obstetric data, pregnancy anxiety (PRAQ-17), childbirth self-efficacy and childbirth satisfaction. PRAQ-17, Pregnancy-Related Anxiety Questionnaire; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.

Data collection began on 6 November 2025, and is expected to be completed on 6 July 2026. To ensure integrity, ethical rigour and proper data monitoring, a supervisor from the university’s ethics committee will be appointed to audit the implementation of the research process.

Study setting

This study is being conducted at prenatal counselling centres (physiological childbirth preparation classes) affiliated with Babol University of Medical Sciences, Babol, Iran. These centres provide routine antenatal care and standard childbirth preparation classes.

Participants in the control group will receive routine education and care at these centres. Participants in the intervention group, in addition to routine care, will receive Bowen-based systemic counselling in small groups of 6–10 participants over 6 weekly sessions (90 min per session). The sessions include one in-person session at the counselling centre and five virtual group sessions conducted via a secure online platform.

Randomisation and allocation concealment

Following baseline assessment and confirmation of eligibility, participants will be randomly assigned to either the intervention group (systemic counselling) or the control group (routine care) in a 1:1 ratio using permuted block randomisation with a block size of four. A total of 18 blocks will be generated to allocate 72 participants equally between the two groups (36 participants per group). The randomisation sequence will be generated using Random Allocation Software by an independent statistician who will not be involved in participant recruitment, intervention delivery or outcome assessment.

To ensure allocation concealment, the statistician will prepare the randomisation list and code the group assignments. The allocation list will be password-protected and accessible only to the study supervisor. The researcher responsible for participant enrolment will not have access to the randomisation sequence or group codes. Group assignment will occur only after completion of baseline assessments to prevent prediction of upcoming allocations and minimise selection bias.

Due to the nature of the counselling intervention, blinding of participants and counsellors will not be feasible. However, measures will be implemented to reduce detection bias and improve the internal validity of the trial.

Eligible participants will be recruited through convenience sampling from prenatal healthcare centres in Babol, Iran. After receiving detailed information about the study objectives and procedures, written informed consent will be obtained from all participants prior to random allocation (figure 2).

Figure 2. Study flow diagram showing participant progression through the trial. The figure illustrates the planned flow of participants through the study, including assessment for eligibility, enrolment, randomisation, allocation, follow-up and analysis. Women who meet the inclusion criteria will be invited to participate and will receive information about the study objectives and voluntary participation. Those who agree will sign informed consent and complete baseline data collection (t₀). Participants will then be randomised and allocated to either the intervention group (n=36), which will receive virtual counselling, or the control group (n=36), which will receive routine prenatal care. Follow-up assessments will be conducted at 6 weeks after the intervention (t₁) and from 2 hours after delivery until discharge (t₂). Any loss to follow-up will be reported. Data will be analysed for all participants in each group (n=36).

Blinding

Due to the nature of the intervention (behavioural counselling), blinding of participants and the intervention provider is not feasible. Therefore, this is an open-label trial. However, to minimise bias, the statistician responsible for data analysis will be blinded to group allocation and will have no knowledge of the study procedures or group codes. The statistician will receive only anonymised data for analysis.

Patient selection and recruitment

All eligible participants in this study will be primiparous pregnant women receiving routine antenatal care at urban and rural health centres affiliated with Babol University of Medical Sciences, located in Babol city, northern Iran.

Inclusion criteria

• Gestational age between 20 and 28 weeks

• Maternal age between 18 and 45 years

• Ability to read and write

• Willingness to participate and provide written informed consent

• No previous history of childbirth

• No major pregnancy complications (such as pre-eclampsia, gestational diabetes or placental disorders)

• No diagnosed psychiatric disorders

• Spontaneous (non-assisted) conception

• Possession of a smartphone capable of online communication

• Intended pregnancy

• Participation in routine childbirth preparation classes

Exclusion criteria

• Ongoing psychiatric or pharmacological treatment.

• Any medical or obstetric condition that may interfere with study participation.

• Participants who meet the eligibility criteria will be selected through convenience sampling from women attending the antenatal clinics. After obtaining written informed consent, participants will be randomly assigned to either the intervention or control group using block randomisation with a block size of four, as generated by a statistician using Random Allocation Software. Allocation concealment will be ensured through coded assignment lists accessible only to the study supervisor.

• Women who develop serious medical conditions during the study, withdraw consent or fail to complete the questionnaires will be excluded from the final analysis.

Recruitment strategies

• Potential participants will be identified during routine antenatal care visits at urban and rural health centres affiliated with Babol University of Medical Sciences.

• Research team members will provide information brochures and explain the study to eligible women during their routine visits.

• Posters and informational materials will be placed in waiting areas of participating health centres.

• If enrolment is slower than anticipated, additional health centres will be approached, and the recruitment period may be extended.

Sociodemographic and fertility data

• The Sociodemographic and Fertility Questionnaire will collect information on participants’ age, educational level, occupation, place of residence, gestational age (based on ultrasound), height, weight and history of pregnancy or abortion. Additional items include planned or unplanned pregnancy status, participation in childbirth preparation classes and smartphone ownership.

• This questionnaire will also gather data on participants’ sources of health information, such as healthcare providers, educational classes or online resources.

• All sociodemographic and fertility-related data will be obtained from both the intervention and control groups prior to the start of the intervention (T0).

Intervention and comparator

Experimental intervention

The intervention in this study will consist of Bowen Family Systems counselling, designed to promote emotional awareness, self-differentiation and effective communication within family relationships during pregnancy. The intervention content has been developed based on Bowen’s theoretical framework (Bowen, 1978; Kerr and Bowen, 1988) and relevant literature, and adapted to the cultural context of Iranian families. The validity of the intervention materials has been reviewed and confirmed by faculty members of the research team and three external experts in midwifery and reproductive health.

The counselling protocol was developed through a systematic three-step process: (1) theoretical foundation—extracting key concepts from Bowen Family Systems Theory (differentiation, triangulation, nuclear family emotional system and multigenerational transmission patterns); (2) needs assessment—conducted with 15 pregnant women from the target population to identify common anxiety triggers, family conflict patterns and emotion regulation difficulties during pregnancy; and (3) structured session design—each session follows a consistent pedagogical sequence: homework review → psychoeducation → skill demonstration → group discussion → between-session task.

The protocol consists of seven sessions: one orientation session (pre-implementation) and six core sessions. The orientation session and Session 1 will be conducted face-to-face in a group format (6–10 participants). Sessions 2 through 6 will be conducted online via Zoom due to the geographic dispersion of participants. Each session will last 90 min.

The detailed structure and content of the seven counselling sessions are presented in table 1.

Table 1. Bowenian systemic counselling protocol: session-by-session outline of the 7-session intervention.

Session	Objectives	Key activities	Homework and details
Pre-implementation (orientation)	Build group cohesion; establish therapeutic framework; introduce study procedures	Present session rules; facilitate introductions; review confidentiality; familiarise participants with questionnaires	Homework: complete demographic and baseline questionnaires Format: face-to-face, group (6–10), 60–90 min
Session 1: understanding anxiety	Recognise sources of anxiety; identify emotional/physiological reactions	Discuss family anxiety symptoms; psychoeducation on chronic anxiety; introduce differentiation vs fusion	Homework: record anxiety-provoking situations in a table Format: face-to-face group, 90 min Example: ‘If a child’s crying triggers anxiety, identify feelings and alternative responses’
Session 2: emotion management	Identify and label emotions; develop regulation and communication skills	Review homework; discuss emotional vs rational responses; analyse family-of-origin; guided imagery	Homework: family traits table (compare self with mother, father, others) Format: online (Zoom), 90 min
Session 3: triangulation and emotional distance	Identify intergenerational patterns; understand triangles in anxiety transmission	Introduce triangulation principles; discuss anxiety/conflict triangles; examine closeness/distance mechanisms	Homework: map family triangles; table exercise on stability with third party Format: online (Zoom), 90 min
Session 4: de-triangulation	Facilitate de-triangulation; practice direct, calm communication	Teach constructive vs destructive triangulation; role-play; ‘triangle in the womb’ metaphor	Homework: identify triangles and practice direct dialogue Format: online (Zoom), 90 min Example: practice direct interaction with spouse instead of using a family member for anxiety relief
Session 5: nuclear family emotional system	Improve conflict management; increase awareness of roles and responsibilities	Teach mature emotional functioning; discuss circular causality; compare conflict styles	Homework: conflict resolution chart (recent conflicts, reactions, outcomes) Format: online (Zoom), 90 min
Session 6: responsibility and self-control	Enhance self-regulation; reduce blame; learn non-defensive listening	Practice respectful emotional expression; apply self-advocacy and reflective listening	Homework: apply skills in daily interactions; maintain family hierarchy with respect Format: online (Zoom), 90 min Example: express dissatisfaction toward spouse calmly without blame

The full intervention manual (including session worksheets and facilitator guidelines) is available from the corresponding author on reasonable request.

Comparator (control group)

Participants in the control group will receive no intervention during the study period (waitlist control). They will complete the same outcome assessments at baseline and post-intervention as the intervention group. After completion of the post-test assessments and the end of the study, the counselling protocol will be offered to participants in the control group.

Intervention provider and qualifications

The counselling sessions will be conducted by a Master’s student in midwifery counselling who successfully completed an 8-session workshop on systemic counselling (Bowen approach) under the supervision of a clinical psychologist prior to the start of the trial. The workshop covered the theoretical foundations of Bowen’s family systems theory, techniques of circular questioning, genogram construction and behavioural assignments, as well as their application in perinatal mental health. Throughout the trial, the counsellor will receive weekly supervision from a clinical psychologist with expertise in systemic therapy to ensure treatment fidelity.

Participants in the intervention group will receive a total of seven sessions, including one orientation session and six counselling sessions (one face-to-face and five virtual sessions), starting from 20 weeks of gestation. Each session will last approximately 90 min and will be held weekly in small groups of 6–10 participants. The first session will be conducted in person at the designated health centre, while the subsequent sessions will be conducted online using a secure audiovisual platform (Zoom) accessible via smartphones.

The content and objectives of each counselling session are summarised in table 1. Sessions will cover the main principles of Bowen Family Systems Theory, including understanding the emotional system, managing anxiety, identifying family interaction patterns, differentiation of self and improving communication skills. During each session, the first researcher will facilitate interactive discussions, deliver structured content, reinforce correct information, clarify misconceptions and provide additional support as needed. Participants will be encouraged to complete reflective tasks between sessions to consolidate learning.

Reminders of session schedules will be sent to participants via short message service and notifications in a dedicated messaging group created by the first researcher. Session summaries and educational materials will be shared as text files through this group. The first researcher will remain in contact with participants via messaging or telephone throughout the intervention period to address questions or provide guidance.

Treatment fidelity

To ensure consistency and adherence to the protocol, all counselling sessions will be audio-recorded, and a random sample of 20% of the sessions will be reviewed by an independent supervisor (clinical psychologist) to assess fidelity to the Bowen-based protocol.

Participants in the control group will receive only routine antenatal care in accordance with the national guidelines of the Iranian Ministry of Health and Medical Education, including standard in-person educational sessions delivered by healthcare providers. On completion of the study, the educational materials from the counselling sessions will be shared with the control group through social messaging platforms to ensure equitable access to the intervention content.

Outcome measurement

Primary outcomes

The primary outcomes of this study are anxiety and childbirth self-efficacy among primiparous women. Anxiety will be assessed using the Pregnancy-Related Anxiety Questionnaire (PRAQ-17) at baseline (T0) and immediately after the intervention (T1) in both the intervention and control groups. The PRAQ-17 comprises 17 items across five domains: fear of childbirth (three items); fear of giving birth to a physically or mentally disabled child (four items); fear of changes in marital relationships (four items); fear of mood changes and their impact on the child (three items); and self-focused fears related to changes in the mother’s personal life (three items). Each item is rated on a 7-point Likert scale, with total scores ranging from 17 to 119; higher scores indicate greater pregnancy-related anxiety.

Psychometric properties

The PRAQ-17 has demonstrated good internal consistency (Cronbach’s α=0.78) and acceptable test-retest reliability (r=0.74).^{24 25} Confirmatory factor analysis (CFA) confirmed the five-factor structure, explaining 62% of the total variance. Construct validity was supported by significant positive correlations with the State-Trait Anxiety Inventory (r=0.61) and negative correlations with the Childbirth Self-Efficacy Inventory (r=−0.53).²⁴

Childbirth self-efficacy will be measured using the Childbirth Self-Efficacy Questionnaire, which contains 15 items rated on a 10-point Likert scale, with total scores ranging from 15 to 150. Higher scores indicate higher self-efficacy.

Psychometric properties

The questionnaire has demonstrated strong internal consistency (Cronbach’s α=0.84–0.91) and satisfactory test-retest reliability (ICC=0.85).²⁶ CFA supported the two-factor structure (self-efficacy expectancy and outcome expectancy). Convergent validity was confirmed by significant correlations with self-esteem (r=0.48) and optimism measures (r=0.52).²⁶

Secondary outcomes

The secondary outcomes include overall birth experience and satisfaction with childbirth, assessed within 2 hours after delivery (before hospital discharge) using structured questionnaires.

Childbirth experience will be assessed using the Childbirth Experience Questionnaire (CEQ 2.0) within 2 hours after delivery (before hospital discharge). This questionnaire evaluates the mother’s perception of her birth experience across multiple dimensions.

Childbirth satisfaction will be assessed using the Mackey Childbirth Satisfaction Rating Scale (34 items) within 2 hours after delivery (before hospital discharge). This scale evaluates six subscales: self (nine items), midwife (nine items), spouse (two items), newborn (three items), physician (eight items), and overall satisfaction (three items). The spouse-related items assess perceived emotional support and involvement of the spouse throughout the childbirth process and are not limited to physical presence during labour. Responses are recorded on a 5-point Likert scale, with total scores ranging from 34 to 170; higher scores indicate greater satisfaction.

Psychometric properties

The scale has shown good internal consistency (Cronbach’s α=0.78–0.80 for subscales; α=0.89 for the total scale).^{26 27} CFA confirmed the six-factor structure. The scale demonstrated good content validity (Content Validity Ratio=0.81, Content Validity Index=0.85) and construct validity through known-group comparisons.²⁷ The scale is administered retrospectively within 2 hours after delivery (not during active labour).

Harm assessment

Adverse events or emotional distress will not be systematically assessed, as this is a low-risk behavioural counselling intervention with no anticipated physical harms. However, any participant-reported distress during counselling sessions will be documented and managed by the clinical psychologist supervisor. No serious adverse events are expected.

Sample size and sampling

Based on Ali Shaker Dologh et al²⁸ a minimum of 32 participants per group was required to detect a clinically significant difference (δ=20) with 80% power at a 5% significance level. Allowing for a 10% dropout rate, 36 participants were allocated to each group, resulting in a total sample size of 72. Participants will be recruited using convenience sampling and randomly assigned to the intervention or control groups.

Sample size calculation

$${\displaystyle {\displaystyle n=\frac{2{\sigma }^2(Z_{1-\alpha /2}+Z_{1-\beta }{)}^2}{{\delta }^2}}}$$

where

• σ₁² = 36.35, σ₂² = 17.69

• δ=20

• Z₁−α/2=1.96

• Z₁−β=0.84.

Control of variability in intrapartum care

To ensure consistency of care despite the involvement of different midwives and doctors during labour and delivery, the following strategies will be implemented:

Both teaching hospitals follow the same standardised national protocols for routine intrapartum and postpartum care as mandated by the Iranian Ministry of Health.

Data on delivery-related variables (mode of delivery, type of attending midwife/physician, duration of labour, use of epidural analgesia, episiotomy and intrapartum complications) will be collected.

These variables will be included as covariates in the statistical analysis (ANCOVA or multiple regression) to adjust for their potential effects on childbirth experience and satisfaction outcomes.

Sensitivity analyses will be conducted excluding participants with major intrapartum interventions (eg, emergency caesarean section, prolonged labour) to assess the robustness of the findings.

Statistical analysis

The primary analysis will be conducted on an intention-to-treat (ITT) basis, meaning that all randomised participants will be included in the analysis and analysed according to the group to which they were originally assigned (intervention or control), regardless of protocol adherence or treatment received. At baseline, participants’ demographic and clinical characteristics will be compared between groups to assess the effectiveness of the randomisation process.

To handle missing data under the ITT principle, multiple imputation will be performed for missing outcome data, including post-intervention scores related to pregnancy-related anxiety, childbirth self-efficacy, childbirth experience and childbirth satisfaction. Baseline demographic and clinical variables, as well as group allocation, will be included in the imputation model. For sensitivity analysis, in addition to the multiple imputation approach, a per-protocol analysis will be conducted using complete case analysis to assess the robustness of the findings.

Data will be analysed using IBM SPSS Statistics V.22. Descriptive statistics will be presented as mean (± SD) for continuous variables and frequency (percentage) for categorical variables. Between-group differences at baseline will be assessed using independent-samples t-tests for continuous variables and χ² tests for categorical variables; if the assumptions of these tests are not met, appropriate non-parametric alternatives will be applied.

To evaluate the effect of the intervention, analysis of covariance (ANCOVA) will be conducted with the post-intervention outcome as the dependent variable and the baseline score as a covariate to adjust for initial differences. Results will be reported as adjusted mean differences with 95% CIs.

No formal subgroup analyses are planned due to the sample size. For sensitivity analysis, in addition to the multiple imputation approach, a per-protocol analysis will be conducted to assess the impact of protocol deviations on the results.

A two-tailed p value<0.05 will be considered statistically significant for all analyses.

Follow-up during labour and delivery

During labour and delivery, participants will be followed by the Master’s student in midwifery counselling (the same person who will deliver the counselling intervention). After necessary coordination with hospital authorities, the Master’s student will attend the maternity ward of the two (Ayatollah Rouhani Hospital or Yahyanejad Hospital) teaching hospitals affiliated with Babol University of Medical Sciences.

All participants will be referred to these two hospitals for delivery. Both hospitals follow standard delivery and postpartum care protocols consistent with national guidelines, which ensures minimal variability in childbirth experiences related to hospital setting.

The postpartum outcome assessments (Childbirth Self-Efficacy Questionnaire, CHQ and Childbirth Satisfaction Scale) will be self-completed by the mothers within 2 hours after delivery until hospital discharge. The Master’s student will oversee the process and provide assistance if needed, but the questionnaires will be filled out by the mothers themselves.

Current protocol version

V.1.0 (dated 14 September 2025). No protocol amendments have been made since the original registration. Any future modifications will be updated in the Iranian Registry of Clinical Trials registry (irct.behdasht.gov.ir).

Ethics and dissemination

This trial is registered with the IRCT (IRCT20100510003902N7, https://irct.behdasht.gov.ir/trial/86033) and has received approval from the Ethics Committee of Babol University of Medical Sciences (approval code: IR.MUBABOL.HRI.REC.1404.070). The study will adhere to the principles outlined in the Declaration of Helsinki. On completion of data analysis, the results will be disseminated through publication in peer-reviewed scientific journals and presentations at national and international conferences. Any significant protocol modifications will be promptly communicated to the ethics committee, trial participants and trial registries. Ethics Committee contact: Ethics Committee of Babol University of Medical Sciences Pajouhan Research Center Website: http://pajouhan.mubabol.ac.ir Email: pajouhan.mubabol

Consent or assent

Written informed consent will be obtained from all participants prior to any study-related procedures. The consent process will be conducted by the principal investigator or a trained research assistant in a private room at the antenatal healthcare centre. Each potential participant will receive a thorough verbal explanation of the study’s purpose, procedures, potential risks and benefits, voluntary participation and the right to withdraw at any time without any consequences. Following the verbal explanation, participants will be given sufficient time to ask questions and consider their decision. Those who agree to participate will sign and date the informed consent form. A copy of the signed consent form will be provided to each participant. A sample participant consent form is provided as online supplemental file 1.

Protocol amendments

The study protocol is final and has been approved by the Research Ethics Committee of Babol University of Medical Sciences (approval code: IR.MUBABOL.HRI.REC.1404.070). No protocol amendments are planned, as the trial is currently ongoing with the approved protocol. If, however, any unforeseen important protocol modification becomes necessary, it will be submitted to the ethics committee for approval. Once approved, the amendment will be communicated to the trial registry (IRCT), and all affected parties (investigators, participants and the journal) will be notified accordingly.

Additional consent provisions for ancillary studies

Not applicable. This trial does not involve the collection of biological specimens (eg, blood, saliva, urine) from participants. Furthermore, no ancillary studies are planned that would require additional consent for the use of participant data or biological samples.

Confidentiality

To protect confidentiality, each participant will be assigned a unique code. Personal identifiers will be kept separate from study data. Paper data will be stored in a locked cabinet, and electronic data on a password-protected, encrypted computer, accessible only to authorised team members. No personal identifiers will be shared or published; only aggregated data will be used. Data will be retained for 5 years, then destroyed. Any confidentiality breach will be reported immediately to the participant and the ethics committee.

Ancillary and post-trial care

Due to the low-risk, non-invasive nature of the intervention (systemic counselling), no ancillary or post-trial care is anticipated. However, if any participant experiences psychological distress during or after the trial, she will be referred to a qualified psychologist for appropriate support at no additional cost. Compensation for harm is not applicable, as no serious adverse events are expected. The trial does not involve any experimental drug or device.

Data monitoring

Given the low-risk nature of the intervention (systemic counselling), which is non-invasive and has no anticipated serious adverse events, a formal independent Data Monitoring Committee was not established. Instead, the study will be overseen by the study supervisor and a faculty member of the Department of Psychology. Together, they will be responsible for monitoring data collection, ensuring participant safety, adherence to the protocol and reporting any adverse events to the institutional ethics committee. The funder had no role in data monitoring or analysis.

Interim analysis and stopping guidelines

No interim analysis is planned for this trial because of the low-risk nature of the intervention (systemic counselling) and the small sample size. Therefore, no formal stopping guidelines have been defined. The trial will be terminated only on completion of data collection for all participants. In the event of any serious adverse event (though none are anticipated), the study supervisor and the appointed trial monitor (faculty member from the Department of Psychology) will immediately notify the Ethics Committee and the trial may be terminated if deemed necessary by the Ethics Committee.

Trial monitoring

By an official letter from the Research Vice-Chancellor of Babol University of Medical Sciences, a faculty member of the Department of Psychology has been appointed as the trial monitor. The appointed monitor will have full oversight of the research implementation and will submit a written report of the findings to the Ethics Committee. Monitoring will be conducted throughout the study period. No additional external monitoring or auditing is planned.