Fear of ChildbirthNCT04690881
The Effect of Psychodrama for Treating Fear of Childbirth
A study testing Psychodrama group psychotherapy in people with Fear of Childbirth, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth
- What is being tested?
- Psychodrama group psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fear of Childbirth
- Being tested
- Psychodrama group psychotherapy
- Keywords
- Fear of childbirth, Pychodrama, Psychoeducation, Childbirth-antenatal education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychodrama group psychotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Postpartum 7-14 days
Secondary outcomes (1)
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.
Measured: Postpartum 6. Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start3 Dec 2018
- Primary completion28 Feb 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadime Bayrı Bingöl, Marmara University
- Investigators
- Fadime Bingöl, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690881
- Sponsor's protocol ID
- 09.2018.672
- Status last verified
- Dec 2020
- First submitted
- 28 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychodrama as a New Intervention for Treating Fear of Childbirth: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04690881
- Acronym / sponsor ID
- 09.2018.672
- Conditions
- Fear of Childbirth
- Keywords
- Fear of childbirth, Pychodrama, Psychoeducation, Childbirth-antenatal education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychodrama group psychoteraphy | Experimental | Behavioral: Psychodrama group psychotherapyPsychodrama 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychodrama group psychotherapyIn 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. | Behavioural | Psychodrama group psychoteraphy |
Primary outcome
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.
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.
1 secondary outcome
Postpartum posttraumatic stress
Time frame: Postpartum 6. Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fadime Bingöl principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychodrama group psychotherapy in people with Fear of Childbirth, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of childbirth (time frame: 6 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.