NCT04690881

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 3, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

1.2 years

First QC Date

December 28, 2020

Last Update Submit

December 31, 2020

Conditions

Keywords

Fear of childbirthPychodramaPsychoeducationChildbirth-antenatal education

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Postpartum posttraumatic stress

    Postpartum 6. Months

Study Arms (2)

Psychodrama group psychoteraphy

EXPERIMENTAL

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.

Behavioral: Psychodrama group psychotherapy

Childbirth-antenatal education

NO INTERVENTION

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.

Interventions

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.

Psychodrama group psychoteraphy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, 34854, Turkey (Türkiye)

Location

Study Officials

  • Fadime Bingöl

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd. RN. Assistant Professor

Study Record Dates

First Submitted

December 28, 2020

First Posted

December 31, 2020

Study Start

December 3, 2018

Primary Completion

February 28, 2020

Study Completion

December 1, 2020

Last Updated

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations