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

Determining the effect of an educational intervention based on a trauma-informed care approach on fear of childbirth and childbirth self-efficacy in pregnant women with a history of traumatic childbirth.

A randomized, double-blind, controlled, parallel-group Phase 2 clinical trial involving 80 patients. Randomization is performed using a block randomization method with an equal allocation ratio (1:1); the allocation sequence is concealed using opaque, sealed envelopes and administered by an individual independent of the researcher.

The setting for this study was the prenatal care clinics at hospitals affiliated with Qom University of Medical Sciences. The blinding method employed was double-blinding, involving both the participants and the data analyst.

Inclusion criteria: 1. Provision of informed consent to participate in the study; 2. Age range of 18 to 40 years; 3. Gestational age between 24 and 28 weeks; 4. Ultrasound-confirmed singleton pregnancy; 5. History of at least one traumatic childbirth in previous pregnancies, based on two items from Criterion A of the City BiTS scale; 6. Ability to read, write, and comprehend Persian. Exclusion criteria: 1. Documented history of severe/major psychiatric disorders and substance or alcohol abuse; 2. Presence of serious obstetric complications or high-risk pregnancy requiring hospitalization or intensive care.

The educational intervention group will receive a trauma-informed program delivered in four weekly, 90-minute sessions. The control group will receive a peer-attention training program consisting of four weekly, 90-minute sessions; a trauma-informed counseling intervention will not be administered to the control group participants during the study.

Fear of childbirth

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.

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.

I haven't decided yet—the release schedule is not yet clear.

I haven't decided yet—the release schedule is not yet clear.

Individuals employed in scientific and research institutions

In a situation where all group members agree.

Zohreh Momeni Movahed

The applicant should send an email to Dr. Momeni Movahed. It will be sent if approved.