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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04690881
Other study ID # 09.2018.672
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 3, 2018
Est. completion date December 1, 2020

Study information

Verified date December 2020
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date December 1, 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Psychodrama group psychotherapy
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.

Locations

Country Name City State
Turkey Marmara University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fear of childbirth 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. 6 week
Primary Fear of Childbirth 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. Postpartum 7-14 days
Secondary Postpartum posttraumatic stress 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. Postpartum 6. Months
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