- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07015086
- Original Trial
Guided Imagery and Positive Birth Experience Sharing on Fear of Childbirth and Self-Efficacy (non)
The Effect of Guided Imagery and Positive Birth Experience Sharing on Fear of Childbirth and Self-Efficacy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Problem Definition Cesarean delivery has significant benefits in high-risk pregnancies, but unnecessary and excessive use of cesarean section has negative consequences on the physical, emotional, and mental health of both mothers and babies. It also places an increasing financial burden on the healthcare system . The increase in the rate of planned cesarean sections before birth cannot be explained by clinical risk factors. This situation can be explained by mothers' preference for planned cesarean sections.
Women's preferences for cesarean sections before birth are influenced by social and cultural factors as well as psychological factors. The most commonly reported psychological factors associated with birth preferences are birth self-efficacy and fear of childbirth. Birth self-efficacy is defined as a person's belief that they can cope with the act of childbirth and the vaginal birth process. Carlson et al. reported that nulliparous women with low self-efficacy in the third trimester of pregnancy experienced higher levels of fear of childbirth compared to women with high self-efficacy. In another study, Lowe found that nulliparous women with lower childbirth self-efficacy were more likely to plan for a cesarean delivery compared to those with higher childbirth self-efficacy. In a study by Schwartz and colleagues, it was determined that self-efficacy is significantly associated with birth preference, independent of parity, and that the intention to have a cesarean delivery increases as self-efficacy decreases. Reducing fear of vaginal birth, thereby increasing positive perceptions of vaginal birth, is important in reducing cesarean preferences.
Having a positive birth experience with vaginal birth or hearing about someone else's positive birth experience can be effective. The sharing of birth stories has increased with the development of new technologies, and women can more easily access others' birth stories through multimedia platforms. Carlsson et al. reported that 97% of nulliparous women had heard birth stories from their mothers and friends. Amyx et al. noted that birth stories are the third most important source of information for nulliparous women, after healthcare professionals and prenatal classes. In a qualitative study of nulliparous women, birth stories were identified as the most useful source of information by 71% of women. Regardless of the type of birth, birth stories have a strong effect on self-efficacy and fear. Therefore, listening to positive birth stories may reduce birth fear in pregnant women.
In recent years, relaxation techniques aimed at reducing fear of childbirth have been increasingly used. One such relaxation technique, mental imagery, is a method for treating stress and anxiety by replacing distressing memories with positive mental images. This involves instructional guidance that triggers sensory experiences, behavioral, and physiological responses. Boryri et al. (2019) found that visualization was effective in reducing fear of childbirth in pregnant women to prevent planned and unnecessary cesarean sections. This study will be conducted to determine the effect of positive birth experience sharing and visualization on birth self-efficacy and fear of childbirth.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: sıdıka pelit aksu, Dr.
- Phone Number: +905069583180
- Email: sidikapelit@hotmail.com
Study Locations
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Ankara, Turkey
- Nursing Faculty of Gazi University
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Contact:
- sıdıka pelit aksu, Dr.
- Phone Number: 05069583180
- Email: sidikapelit@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: experimental group
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.
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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.
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No Intervention: control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difference of scores of the Wijma Childbirth Expectation/Experience Scale Version A
Time Frame: 8 weeks
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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.
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8 weeks
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Difference of scores of the Labor Self-Efficacy Scale-Short Form.
Time Frame: 8 weeks
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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.
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8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E-77082166-604.01-1251133
- Non (Other Identifier: Non)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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