NCT07015086

Brief Summary

Brief Summary This randomized controlled trial evaluates the effects of positive birth experience sharing combined with guided imagery on fear of childbirth and childbirth self-efficacy in primiparous pregnant women. The study is a single-center, two-arm, parallel-group randomized controlled trial using stratified block randomization based on baseline fear of childbirth. A total of 62 pregnant women were randomized in a 1:1 ratio to the intervention group (n=31) or control group (n=31). Participants were enrolled at 26-28 weeks of gestation. Before randomization, participants completed the Personal Information Form, the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A), and the Childbirth Self-Efficacy Inventory-Short Form (CBSEI-C32) online. Participants were stratified according to their baseline W-DEQ-A scores and then randomly allocated to the intervention or control group. The intervention was delivered individually and online via WhatsApp. Women in the intervention group participated in an approximately 30-minute individual online session during which one of the researchers shared a positive personal birth experience and answered participants' questions about childbirth. Participants were also provided with a standardized Turkish guided imagery audio recording based on childbirth-focused guided imagery techniques. They were instructed to listen to the approximately 20-minute recording independently once or twice daily for 10 weeks, preferably before bedtime. Daily WhatsApp reminders and a guided imagery exercise follow-up chart were used to support and monitor adherence. Women in the control group received routine antenatal care and did not receive the positive birth experience sharing or guided imagery intervention. At the end of the 10-week intervention period, participants in both groups completed the W-DEQ-A and CBSEI-C32 online. Within the first three days after childbirth, the W-DEQ-B was administered online and mode of birth was recorded.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Completed
Last Updated

September 9, 2026

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

June 3, 2025

Last Update Submit

September 3, 2026

Conditions

Keywords

birthguided imagerybirth fearpositive birth experienceself-efficacy

Outcome Measures

Primary Outcomes (3)

  • Fear of Childbirth

    Fear of childbirth will be assessed using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A). The scale consists of 33 items, with total scores ranging from 0 to 165. Higher scores indicate greater fear of childbirth.

    Baseline (26-28 weeks of gestation) and 10 weeks after baseline

  • Difference of scores of the Labor Self-Efficacy Scale-Short Form.

    There is a difference between the intervention and control groups in terms of the mean post-test scores of the Labor Self-Efficacy Scale-Short Form.The scale has two sub-dimensions: outcome and adequacy expectations. Each sub-dimension of the scale consists of 16 questions. The lowest score that can be obtained from the scale sub-dimensions is 16, and the highest score is 160. A high score obtained from the sub-dimensions indicates that pregnant women have high adequacy and outcome expectations regarding birth. Responses on the Likert-type scale are scored from 1 to 10. The lowest total score that can be obtained from the scale is 32, and the highest score is 320. High scores obtained from the scale indicate that pregnant women have high levels of self-efficacy in labor.

    8 weeks

  • Childbirth Self-Efficacy

    Childbirth self-efficacy will be assessed using the Childbirth Self-Efficacy Inventory-Short Form (CBSEI-C32). The 32-item scale includes Outcome Expectancy and Efficacy Expectancy subscales. Total scores range from 32 to 320, with higher scores indicating greater childbirth self-efficacy.

    Baseline (26-28 weeks of gestation) and 10 weeks after baseline

Study Arms (2)

experimental group

EXPERIMENTAL

Pregnant women in the intervention group will receive an individual online intervention at 26-28 weeks of gestation via WhatsApp®. During an approximately 30-minute session, one researcher will share her positive birth experience and answer participants' questions about childbirth. Participants will then receive a standardized Turkish MP3 recording based on Rossman's (2015) guided imagery techniques. They will be instructed to listen to the approximately 20-minute recording once or twice daily for 10 weeks, preferably before bedtime. Daily WhatsApp® reminders and a follow-up chart will be used to support and monitor adherence.

Behavioral: Guided Imagery and Positive Birth Experience Sharing

control group

NO INTERVENTION

Participants in the control group will receive routine antenatal care and no study intervention. The W-DEQ-A and CBSEI-C32 will be administered online at baseline and 10 weeks later, following the same assessment schedule as the intervention group. Within the first three days after childbirth, participants will complete the W-DEQ-B online, and mode of birth will be recorded.

Interventions

The positive experience will be shared by one of the researchers and the pregnant women's questions will be answered after the sharing. The mental imagery techniques prepared by Rossman (2015) to facilitate birth will be used for the mental imagery application. After the training, the mental imagery instructions will be given to the pregnant women as an audio recording in mp3 format. The pregnant women will be asked to do the mental imagery once or twice a day for at least 8 weeks. The mental imagery application takes approximately 20 minutes. The pregnant women will be reminded to do the application every day via the Whatsapp® application. The pregnant women will be asked to mark whether they do the application every day or not on the weekly follow-up chart.

experimental group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older Primiparous At 26-28 weeks of gestation at enrollment No maternal or fetal complications during the current pregnancy (e.g., gestational diabetes, hypertension, preeclampsia, intrauterine growth restriction, or congenital anomalies) No mental, hearing, visual, language, or other communication problems that could interfere with participation Able to use WhatsApp® and access the online study procedures Willing to participate in the study and provide informed consent

You may not qualify if:

  • Development of a maternal or fetal complication during the study Birth before 37 weeks of gestation Withdrawal from the study at the participant's request Failure to complete the post-intervention assessment Failure to perform the guided imagery exercise for three consecutive days (intervention group only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursing Faculty of Gazi University

Ankara, Turkey, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Imagery, Psychotherapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor in the department of obstetrics, gynecology and diseases nursing

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 11, 2025

Study Start

October 15, 2025

Primary Completion

October 1, 2026

Study Completion

October 1, 2026

Last Updated

September 9, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared to protect participant privacy and confidentiality. De-identified data may be made available from the corresponding author upon reasonable request, subject to ethical and institutional requirements.

Locations