- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07382609
The Effect of Creating a Birth Story in the Labor Room on Fear of Childbirth
The Effect of Creating a Birth Story in the Labor Room on Fear of Childbirth and Birth Comfort in Primiparous Pregnant Women
The aim of this study is to reduce the fears of women who will give birth and increase their comfort. In the literature review conducted for this purpose, no study has yet been found that examines the effect of creating a birth story in the labor room on the fear of birth and birth comfort in primiparous pregnant women. In order to fill this gap in the literature, pregnant women in the labor room will be asked to create their birth stories and the effect of this on fear of birth and birth comfort will be examined.
The hypotheses of the study are as follows:
H1a: Creating a birth story in the labor room affects fear of birth H1b: Creating a birth story in the labor room affects birth comfort.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Battalgazi̇
-
Malatya, Battalgazi̇, Turkey (Türkiye)
- İnönu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:- All primiparous pregnant women who are literate,
- Over the age of 18,
- Not experiencing a risky pregnancy,
- Not becoming pregnant with assisted reproductive techniques,
- Planned to have a vaginal birth,
- In the latent phase of labor,
- Do not have any psychiatric disorders,
- Do not have any health problems in themselves or their babies,
- Do not have a history of ex fetus will be included in the study.
Exclusion Criteria:
- Pregnant women with an indication for caesarean section during the latent phase of labour will not be included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No Intervention:
GROUP WITHOUT BIRTH STORY
|
|
|
Experimental: Experimental
Birth story creating group
|
The birth story is created by the pregnant women in the labor room writing their feelings on a transparent wallpaper attached to the wall.
The pregnant woman, the midwife, the father and the doctor can also write their feelings and thoughts on this wallpaper.
In this way, the pregnant woman looks at the wall on which positive thoughts are written throughout the labor and thus the fear of birth is reduced.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prenatal Self Evaluation Questionnaire score
Time Frame: Baseline (latent phase of labor) and prior to active labor (at 4 cm cervical dilatation)]
|
The scale developed by Lederman determines women's adaptation to pregnancy and motherhood.
This scale is a 4-point Likert-type scale with 7 sub-dimensions and 79 items.
The scores that can be obtained from the scale are between 10 and 40.
|
Baseline (latent phase of labor) and prior to active labor (at 4 cm cervical dilatation)]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Childbirth Comfort Questionnaire- CCQ score
Time Frame: Immediately prior to active labor (at 4 cm cervical dilatation)
|
The scale consists of 9 questions and is a 5-point Likert type (1=Strongly disagree, 2=Mostly disagree, 3=Partially agree, 4=Mostly agree, 5=Totally agree).
The items are expected to be answered considering the comfort of the delivery room.
Each statement reports a certain sense of comfort (relaxation, relief or superiority) and dimensions (physical, environmental, psychospiritual or social).
A minimum of 9 and a maximum of 45 points can be obtained from the scale.
It can be thought that as the score value of the scale increases, comfort increases, and as the score value decreases, comfort decreases.
|
Immediately prior to active labor (at 4 cm cervical dilatation)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Esra GÜNEY, PhD, İnönu University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Other Study ID Numbers
- 5499
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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