- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04690881
The Effect of Psychodrama for Treating Fear of Childbirth
December 31, 2020 updated by: Fadime Bayrı Bingöl, Marmara University
Psychodrama as a New Intervention for Treating Fear of Childbirth: a Randomized Controlled Trial
This study is a randomized controlled study.
This research was carried out with the aim of determining the effect of psychodrama-based pregnancy education program on fear of childbirth (FOC).
The population of the study consisted of 18-45 years old pregnant who with high fear of childbirth.
The sample of the study was determined as 150 pregnant with confidence level of 95% and theoretical power of 95%.
The pregnant women were divided into two groups of 75 pregnant.
In addition to routine pregnancy training, a 90-minute psychodrama study was carried out to the experimental group.
Data were collected using the information form, Wijma Delivery Expectancy/ Experience Questionnaire Version A (W-DEQ), Wijma Delivery Expectation / Experience Questionnaire Version B (W-DEQ), City Birth Trauma Scale and Edinburgh Postpartum Depression Scale.
The data obtained were assesment using the SPSS (Version 21.0) package program on the computer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The pregnant women were divided into two groups of 75 pregnant.
In addition to the 6-week routine pregnancy training, a 90-minute psychodrama study was conducted to the experimental group.
The experimental group was divided into 6 subgroups and trained (min = 9, max = 14).
The control group was divided into 6 subgroups and trained (min = 11, max = 14).
Prenatal psychodrama is held by psychodrama psychotherapists in individual and group therapy sessions.
In these sessions the pregnant mother encounters herself, her baby, her partner, her mother, her fear of childbirth and the moment of birth; she may act as protagonist in some scenes and in this way she closes any unfinished business from the past and rehearses the future in a safe therapeutic environment.Data were collected using the information form, Wijma Delivery Expectancy/ Experience Questionnaire Version A (W-DEQ), Wijma Delivery Expectation / Experience Questionnaire Version B (W-DEQ), City Birth Trauma Scale and Edinburgh Postpartum Depression Scale.
The data obtained were assesment using the SPSS (Version 21.0) package program on the computer.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34854
- Marmara University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- willing to participate in the study voluntarily,
- non-disabled (hearing, seeing, understanding),
- having 38 or more points from Wijma Birth Experience / Expectation Scale A,
- living with his wife,
- primipary,
- not diagnosed with risky pregnancy and
- women with suitable weeks of gestation (between 20-30 weeks) were included in the study.
Exclusion Criteria:
- those who were diagnosed with risky pregnancy during the training,
- did not attend the first week of the pregnancy training program,
- were absent for more than a week,
- had difficulty following group studies,
- completed the forms incompletely, and
- did not want to continue working / gave up from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Psychodrama group psychoteraphy
Psychodrama is not just a training but also a treatment technique where an individual is offered a potential cure, as well as improvement and awareness for his or her ongoing relationships within the group.
In psychodrama, the participant is given an opportunity to re-experience of earlier incidents for a second time so that the person could be free from the impacts of that earlier experience.
All of this happens simultaneously with joy, tears, laughter, and depth of feeling.Prenatal psychodrama is held by psychodrama psychotherapists in individual and group therapy sessions.
In these sessions the pregnant mother encounters herself, her baby, her partner, her mother, her fear of childbirth and the moment of birth; she may act as protagonist in some scenes and in this way she closes any unfinished business from the past and rehearses the future in a safe therapeutic environment.
In this study, 90-minute psychodrama practice was conducted in addition to pregnancy training for 6 weeks.
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In order to reduce the fear of cihildbirth, pregnant women are given 90 minutes right after the training in addition to the routine pregnancy training.
In the psychodrama-based pregnancy education program, fear of childbirth were assesment by sociometric measurement in order to increase the awareness of pregnant women about birth fear levels in the first week.
Afterwards, they were given the opportunity to express themselves about the factors that may cause fear in pregnant women (their previous traumatic experiences, negative prejudices about childbirth, etc).
The group members shared about their process in the first session and the session was ended.
The session was evaluated with other researchers.
In the following sessions, in order to strengthen their coping with the fear of childbirth, besides psychodrama warm-up games, the basic techniques of psychodrama, role switching, matching and mirror were used in protogonist works.
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No Intervention: Childbirth-antenatal education
Childbirth is one of the most significant events in a parent's life and has the potential to be an exhilarating and fulfilling experience for some or a frightening anxiety provoking experience for others.
Structured antenatal classes have developed worldwide as traditional methods of information sharing have declined and expectant parents look for strategies to prepare for childbirth.
In this study, routine pregnancy training was conducted for 6 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fear of childbirth
Time Frame: 6 week
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Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ): The minimum and maximum scores that can be obtained from the questionnaire are 0 and 165, respectively.
Higher scores indicate greater levels of Fear of Childbirth.
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6 week
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Fear of Childbirth
Time Frame: Postpartum 7-14 days
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Wijma Delivery Expectancy/Experience Questionnaire version B: The minimum and maximum scores that can be obtained from the questionnaire are 0 and 160, respectively.
Higher scores indicate greater levels of Fear of Childbirth.
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Postpartum 7-14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postpartum posttraumatic stress
Time Frame: Postpartum 6. Months
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City Birth Trauma Scale:Total scores can range from 0 to 60. Higher scores are indicative of a greater number of Post Traumatic Stress Disorder symptoms.
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Postpartum 6. Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fadime Bingöl, Marmara University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 3, 2018
Primary Completion (Actual)
February 28, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
December 28, 2020
First Submitted That Met QC Criteria
December 28, 2020
First Posted (Actual)
December 31, 2020
Study Record Updates
Last Update Posted (Actual)
January 5, 2021
Last Update Submitted That Met QC Criteria
December 31, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 09.2018.672
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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