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IRCT20260906070939N1 IRCT 2026-09-17 Ghoum University of Medical Sciences The effect of educational intervention based on trauma-informed care approach on fear of childbirth and childbirth self-efficacy in pregnant women with a history of traumatic childbirth The effect of educational intervention based on trauma-informed care approach on fear of childbirth and childbirth self-efficacy in pregnant women with a history of traumatic childbirth 2026-09-18 anticipated 80 Recruiting https://irct.ir/trial/93102 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Following the selection of participants, the study objectives will be explained to eligible individuals, and written informed consent will be obtained from them. After initial registration and completion of the pre-test questionnaires, participants will enter the randomization phase. To prevent selection bias and ensure a balanced and homogeneous distribution of participants between the intervention and control groups, block randomization with an equal allocation ratio (1:1) will be used. The randomization sequence of the blocks will be generated by a statistician who will have no role in participant recruitment or intervention implementation, using R software version 4.5.1. To prevent the allocation sequence from being predictable to the researcher, variable block sizes (blocks of 4 and 6) will be used. To conceal the allocation sequence from the researcher and participants until the participant’s final enrollment in the study, the standard method of sequentially numbered, opaque, sealed envelopes will be used. Accordingly, the allocation codes (A for the intervention group and B for the control group) will be placed inside opaque envelopes and sealed by an independent individual who is not involved in the sampling process. Only one sequential numerical code will be recorded on the outside of each envelope. After the final registration of each participant and completion of the pre-test, the envelope corresponding to the participant’s number will be opened in sequence, and the participant’s group assignment will be determined. To minimize detection bias and analysis bias, the statistician conducting the data analysis will be fully blinded to the participants’ group assignments. Specifically, the data will be entered and analyzed in the statistical software using only numerical codes (Group 1 and Group 2), and the group codes will be unblinded only after completion of the final analysis. To reduce assessor bias, distribution and collection of the questionnaires at the post-test and follow-up stages will be conducted by an independent individual who is unaware of the mothers’ group assignments. Since the control group will also receive a structurally equivalent educational program in terms of the number, duration, and method of session delivery (peer-attention education), participants will remain unaware of their group assignment throughout the study. Thus, in addition to controlling for attention bias, participant blinding to the study hypothesis will be maximized, Blinding description: Efforts are made to minimize detection bias through the blinding of the statistical analyst and the use of self-report questionnaires. A peer-attention program is provided for the control group—matching the intervention group in the number and duration of sessions—which controls for the attention effect while also facilitating partial blinding of the participants. N/A Childbirth. Intervention 1: Intervention group: The intervention designed for this study is group counseling based on the Trauma-Informed Care (TIC) approach. This structured package was developed by integrating the four fundamental principles of the TIC approach (realization, recognition, response, and resisting re-traumatization) with the four sources of self-efficacy from Bandura’s theory (mastery experiences, vicarious experiences, verbal persuasion, and management of physiological states). The implementation protocol is as follows: the intervention will take place in a dedicated, well-lit, and air-conditioned room within the research setting, featuring a circular seating arrangement (aligning with the principles of collaboration and participation, and the elimination of therapeutic hierarchies in TIC) and ensuring complete privacy (consistent with the TIC principle of physical and psychological safety); it will consist of four 90-minute sessions held once a week. The first session will commence between the 24th and 32nd weeks of pregnancy. Intervention 2: Control group: The attention-matched training program for the control group is implemented as follows: in addition to routine prenatal care, this group will attend four weekly, 90-minute sessions (matching the frequency, duration, and delivery format of the intervention group) in groups of six to eight participants. These sessions will cover general maternal health topics—such as prenatal nutrition, safe physical activity, sleep hygiene, and medication safety—deliberately designed to be unrelated to the mechanisms of the primary intervention (fear of childbirth and childbirth self-efficacy). The content holds no specific therapeutic effect and is intended solely to equate the level of attention and contact time with the provider (controlling for attention bias). The trauma-informed counseling intervention will not be administered to the control group participants during the study. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Elham Mohammadian
School of Nursing and Midwifery; East No. 2 Alley; Moalem Blvd; Qom
Qom Iran (Islamic Republic of) 3715835155 +98 912 758 2479 elhammohammadiyan7898@gmail.com Ghoum University of Medical Sciences scientific Zohreh Momeni Movahed
School of Nursing and Midwifery; East No. 2 Alley; Moalem Blvd; Qom
Qom Iran (Islamic Republic of) 3715835155 +98 912 758 2479 momeni.z@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Giving written and informed consent to participate in the research. Falling within the 18–40 age range. Gestational age between 24 and 28 weeks. Confirmation of singleton pregnancy via ultrasound. A history of at least one traumatic birth in previous pregnancies, based on the perception of the prior birth as a traumatic experience and an affirmative response to at least one of the two Criterion A items of the City BiTS scale—specifically, the individual's belief during labor, delivery, or immediately thereafter regarding the likelihood of serious physical injury or death for themselves or the infant. Ability to read, write, and comprehend Persian in order to communicate with the researcher and accurately complete the questionnaires. 18 years 40 years Female Documented history of severe or major psychiatric disorders (such as psychosis, schizophrenia, bipolar disorder, or major depression with suicidal ideation) Substance or alcohol abuse Occurrence of serious obstetric complications and high-risk pregnancies (such as preeclampsia, placenta previa, uncontrolled gestational diabetes, or the Detection of fetal anomalies via ultrasound) requiring hospitalization or specialized care XV Pregnancy, childbirth and the puerperium Behavior N/A Intervention group: The intervention designed for this study is group counseling based on the Trauma-Informed Care (TIC) approach. This structured package was developed by integrating the four fundamental principles of the TIC approach (realization, recognition, response, and resisting re-traumatization) with the four sources of self-efficacy from Bandura’s theory (mastery experiences, vicarious experiences, verbal persuasion, and management of physiological states). The implementation protocol is as follows: the intervention will take place in a dedicated, well-lit, and air-conditioned room within the research setting, featuring a circular seating arrangement (aligning with the principles of collaboration and participation, and the elimination of therapeutic hierarchies in TIC) and ensuring complete privacy (consistent with the TIC principle of physical and psychological safety); it will consist of four 90-minute sessions held once a week. The first session will commence between the 24th and 32nd weeks of pregnancy. Control group: The attention-matched training program for the control group is implemented as follows: in addition to routine prenatal care, this group will attend four weekly, 90-minute sessions (matching the frequency, duration, and delivery format of the intervention group) in groups of six to eight participants. These sessions will cover general maternal health topics—such as prenatal nutrition, safe physical activity, sleep hygiene, and medication safety—deliberately designed to be unrelated to the mechanisms of the primary intervention (fear of childbirth and childbirth self-efficacy). The content holds no specific therapeutic effect and is intended solely to equate the level of attention and contact time with the provider (controlling for attention bias). The trauma-informed counseling intervention will not be administered to the control group participants during the study. Fear of childbirth. Timepoint: Stage 1 (Pre-test): Prior to the assignment of participants to research groups. Stage 2 (Post-test): Immediately following the conclusion of each group's final training session (for the intervention group: the fourth intervention session; for the control group: the fourth session of the peer-attention training program). Stage 3 (36-week follow-up): To assess the sustainability of the intervention's effects during the peak period of prenatal anxiety. Method of measurement: Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ-A). Childbirth Self-Efficacy. Timepoint: Stage 1 (Pre-test): Prior to the assignment of participants to research groups. Stage 2 (Post-test): Immediately following the conclusion of each group's final training session (for the intervention group: the fourth intervention session; for the control group: the fourth session of the peer-attention training program). Stage 3 (36-week follow-up): To assess the sustainability of the intervention's effects during the peak period of prenatal anxiety.Childbirth. Method of measurement: Childbirth Self-Efficacy Inventory (CBSEI). Ghoum University of Medical Sciences Approved 2026-09-16 Ethics committee of Qom University of Medical Sciences Qom University of Medical Sciences and Health Services, Shahid Lavasani Street (Saheli) Ghoum Ghoum Iran (Islamic Republic of)