NCT07015086

Brief Summary

Abstract This study will be conducted to determine the effect of sharing positive birth experiences and mental imagery on birth self-efficacy and fear of childbirth. The study is a single-center, parallel-group, stratified block (in terms of fear of childbirth level) randomized controlled experimental study. The study sample will consist of a total of 84 participants, with 42 in the intervention group and 42 in the control group. The study is planned to be conducted between July 1, 2025, and July 1, 2026. Inclusion criteria for the study are: WİJMA A scale score average below 85, age over 18, being primiparous, being in the 20th to 26th week of pregnancy, having no complications in the mother or fetus during pregnancy (gestational diabetes, hypertension, preeclampsia, intrauterine growth restriction, congenital anomalies, etc.), having no communication problems (mental, auditory, visual, language, etc.), and volunteering to participate in the study. The study data will be collected using a personal information form, the Wijma Childbirth Expectancy/Experience Scale Version A (W-DEQ A), and the Childbirth Self-Efficacy Scale-Short Form (CBSEI-C32). Women will be invited to participate in online training sessions in groups of 3-10 people. Positive birth stories will be shared with the women, and visualization exercises will be demonstrated. Following the training sessions, the follow-up phase of the study will begin, and women will be provided with an audio recording of the visualization guidelines in MP3 format. Women will be asked to perform visualization exercises at least once or twice daily for a minimum of eight weeks. No intervention will be applied to the control group.

Trial Health

63
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Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet 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

Study Progress54%
Aug 2025Dec 2026

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
3 months until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2026

Last Updated

August 24, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

June 3, 2025

Last Update Submit

August 19, 2025

Conditions

Keywords

birthguided imagerybirth fearpositive birth experienceself-efficacy

Outcome Measures

Primary Outcomes (2)

  • Difference of scores of the Wijma Childbirth Expectation/Experience Scale Version A

    There is a difference between the intervention and control groups in terms of the mean post-test scores of the Wijma Childbirth Expectation/Experience Scale Version A. The minimum score that can be obtained from the scale is 0, and the maximum score is 165. High scores indicate that women have a high fear of childbirth. W-DEQ A score ≤37 indicates mild, 38-65 indicates moderate, 66-84 indicates severe, and ≥85 indicates clinical level fear.

    8 weeks

  • 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

Study Arms (2)

experimental group

EXPERIMENTAL

Pregnant women will be invited to sessions by forming groups of 3-10 people. A face-to-face positive birth experience sharing and mental visualization practice will be done once in the 26-28th weeks of pregnancy at the Gazi University Health Research and Application Center Gynecology and Obstetrics Polyclinic. The positive experience sharing will be done by one of the researchers personally and the pregnant women's questions will be answered after the sharing. The mental visualization techniques prepared by Rossman (2015) to facilitate birth will be used for the mental visualization practice. After the training, the mental visualization instructions will be given to the pregnant women as an audio recording in mp3 format. The pregnant women will be asked to mentally visualize once or twice a day for at least 10 weeks. The mental visualization practice takes approximately 20 minutes. The pregnant women will be reminded to do the practice every day via the Whatsapp® application.

Behavioral: Guided Imagery and Positive Birth Experience Sharing

control group

NO INTERVENTION

No intervention will be applied to the control group. Post-test and follow-up tests will be applied at the same times and with the same scales as the intervention group. Finally, the method of birth will be questioned.

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:

  • The WIJMA A scale score average should be below 85, be over 18 years of age, be primiparous, be in the 20-26th week of pregnancy, not have any complications in the mother or fetus during pregnancy (gestational diabetes, hypertension, preeclampsia, intrauterine growth retardation, congenital anomaly, etc.), not have any communication problems (mental, auditory, visual, language, etc.), and be willing to participate in the study.

You may not qualify if:

  • Failure to perform post-tests,
  • Participant's wish to withdraw from the study at any stage of the study,
  • Pregnancy turning into a risky pregnancy,
  • Birth occurring before the 37th week of pregnancy,
  • Not performing the visualization exercise for at least three consecutive days.

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

Central Study Contacts

sıdıka pelit aksu, Dr.

CONTACT

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

August 25, 2025

Primary Completion (Estimated)

May 25, 2026

Study Completion (Estimated)

December 12, 2026

Last Updated

August 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations