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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Istanbul, Turkey, 34854
        • Marmara University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fear of childbirth
Time Frame: 6 week
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
Time Frame: Postpartum 7-14 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postpartum posttraumatic stress
Time Frame: Postpartum 6. Months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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