Effect of Religion-Based Spiritual Self-Care Education on Fear of Childbirth and Pregnancy Experience Among Pregnant Women: A Randomized Controlled Trial

To determine the effect of religion-based spiritual self-care education during pregnancy on fear of childbirth and pregnancy experience

Three assessment stages: 1) before the intervention (at enrollment, weeks 20–24 of gestation), 2) immediately after the end of the intervention, and 3) four weeks after the end of the intervention.

(gestational weeks 20–24, W-DEQ-A ≥ 66 ≥66 ). Randomization: 1:1 allocation to intervention and control via block randomization and opaque envelopes. Intervention & Follow-up: 5 training sessions vs. routine care; blinded outcome assessment (Tabriz, Iran).

Major Eligibility Criteria Before Randomization Inclusion criteria: Residing in Tabriz. Having a singleton pregnancy at 20–24 weeks of gestation. Scoring ≥66 on the initial childbirth fear assessment. Being committed to religious beliefs and practices. Being able to read and write. Physical or mental disability (based on self-report). History of difficult labor. Known fetal anomalies. History of depression (based on maternal self-report and medical records review).

Intervention Group (

Fear of childbirth and pregnancy experience.

Participants will be allocated to the intervention and control groups using block randomization (with block sizes of 4 and 6, and a 1:1 allocation ratio). Randomization will be stratified based on parity (primigravid and multigravid) and the severity of fear of childbirth (high fear and severe fear). The random allocation sequence will be generated using a computer-based Randomizer software. Allocation concealment will be ensured by an individual not involved in participant recruitment and data collection; the allocation sequence will be written on slips of paper and placed in sequentially numbered, opaque, sealed envelopes, which will be opened in order of participants’ entry into the study.”

Outcome assessors and the data analyst will be blinded to participants’ group allocation.

Individual participant data will not be made publicly available in order to protect confidentiality and privacy. De-identified data and study documents may be provided upon reasonable request, subject to approval by the principal investigator and compliance with ethical requirements. No information that could identify participants will be shared.

5years

Qualified researchers who submit a reasonable request may access the de-identified data and study documents only after approval by the principal investigator and in compliance with ethical and confidentiality requirements. Identifiable participant information will not be shared.

De-identified data may be used only for research purposes related to maternal health, scientific analysis or re-analysis, and systematic reviews. Use of the data to identify participants or for commercial purposes is not permitted.

Requests for access to the de-identified data and study documents should be directed to the principal investigator, [full name], at [email address or telephone number]. Access is subject to the principal investigator’s approval and compliance with ethical and confidentiality requirements.

Applicants must submit a written request to the principal investigator, specifying the purpose of the proposed use, the data required, and how confidentiality will be protected. The principal investigator will review the request for scientific and ethical appropriateness. If approved, the relevant de-identified data and study documents will be provided subject to agreed terms of use and compliance with ethical and confidentiality requirements. No identifiable participant information will be provided

Data and study documents will be shared only in de-identified form. Requests will be reviewed individually, and access is subject to the principal investigator’s approval and compliance with ethical and confidentiality requirements. No information that could identify participants will be shared.