Fear of ChildbirthNCT05217368
the Effect of Mandala Studies on Fear of Birth Outcomes in Primiparous Pregnant
A study testing mandala painting and antenatal education in people with Fear of Childbirth, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Fear experienced at the time of birth and after birth is considered as fear of childbirth. If the fear occurred before pregnancy or if the pregnancy increases the severity of the fear, this can lead to "Tocophobia". Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth
- What is being tested?
- mandala painting and antenatal education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 31 Jan 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who want to participate in the study voluntarily,
- Able to speak and understand Turkish,
- Living with his wife,
- Over 18 years old,
- Primiparous pregnant women
- Without a diagnosis of risky pregnancy and,
Show all 10Show fewer
- Between 24-32 weeks of pregnancy,
- A score of 38 or more on the Wijma Birth Experience/Expectation Scale A,
- Hearing in order to follow group work,
- Those who do not have comprehension and vision problems will be included in the research.
Who cannot join
- Absence from the 6-week pregnant school for more than one week,
- Less than 30 mandala exercises over 6 weeks those who do,
- Filling in the survey forms incompletely,
- Those who develop any health problems during pregnancy will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Fear experienced at the time of birth and after birth is considered as fear of childbirth. If the fear occurred before pregnancy or if the pregnancy increases the severity of the fear, this can lead to "Tocophobia". When the literature is examined; In addition to birth preparation education, different methods such as cognitive behavioral theory, analytical theory, psychodrama, haptotherapy and art therapy groups have been found to be effective in reducing fear of birth. No study has been found in the literature on the effect of mandala on fear of birth and birth outcomes. By reducing the women's fear of childbirth of this study; It is predicted that it will reduce the need for medical intervention at birth, increase the normal birth rate, have a more positive birth experience and contribute to the well-being of postpartum women.
Read the detailed description
This research was planned as a randomized controlled study to determine the effect of mandala studies on fear of labor and delivery results in primiparous pregnant women. We will work with pregnant women who accept to participate in the study among the pregnant women who applied to the online birth and baby preparation training program at the Istanbul Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital Pregnancy Training Center. Since this research was planned experimentally, a power analysis was applied considering the number of pregnant women who applied to the pregnant school of the hospital where the research was conducted in 2020 in order to determine the number of people to be included in each group.( Akın et al. 2018) Sample size, 80% power, 0.05 margin of error, When calculated using the G*Power (3.0.10) Program with an effect level of 0.5, it was determined that at least 48 pregnant women should be recruited for each of the experimental and control groups. Considering that there may be a loss of participants during the study process, it is planned to include 75 pregnant women in both groups, and a total of 150 pregnant women are planned to be included in the study. Randomization of the experimental (n=75) and control (n=75) groups will be provided by the research randomizer.org program.In the study, an introductory information form and Wijma Birth Expectation/Experience (W-DEQ A) scale will be given to the pregnant women who applied to the birth and baby preparation training program to determine the level of fear of birth. Pregnant women with a score of 38 or more will be informed about the subject and invited to the study. During the interview, address and contact information will be obtained from the participants in order to be able to communicate. The forms required for the follow-up of the pregnant women included in the experimental and control groups will be sent to the addresses of the participants by courier in printed form and they will be asked to send them back. In addition to the routine pregnant training, the pregnant women included in the experimental group, at least 5 times a week during the 6 weeks of pregnancy training under the supervision of researcher Tuğba Topcu. They will be asked to do at least 1 mandala work per day. The same mandala study box will be given to each pregnant woman in order to ensure standardization in the pregnant women included in the experimental group. At the end of the training, the researcher Tuğba Topcu will apply the Wijma Birth Expectation/Experience scale to the experimental and control groups in order to determine the level of fear of birth. Postpartum Follow-up Form will be used at the end of delivery, Wijma Birth Expectation/Experience Scale (W DEQ) and Birth Experience Scale will be used to determine the level of birth fear experienced by pregnant women.
Statistical analysis Statistical analysis of the data will be done by using the Statistical Package for the Social Sciences (SPSS) package program and consulting a statistics expert. Apart from the individual characteristics of the individuals included in the study, whether the Wijma Birth Expectation/Experience Scale-Version A, Postpartum Follow-up Chart, Wijma Birth Expectation/Experience Scale-B Version and Birth Experience Scale total scores show a normal distribution; Shapiro Wilks test will be used, if it is found to be normally distributed, mean ± standard deviation will be given as descriptive statistics, and if it is not normally distributed, median (median) and width between quarters values will be given. In the comparison of individual characteristics and scale scores, Independent Sample T test will be applied in independent groups in those with normal distribution, Mann-Whitney U test in independent groups that do not show normal distribution, Paired-Sample T test in dependent groups with normal distribution, and Wilcoxon test in dependent groups that do not show normal distribution.
- Conditions
- Fear of Childbirth
- Being tested
- mandala painting, antenatal education
- Keywords
- Mandala, Pregnancy, Primiparous, Antenatal Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandala paintingOther
In addition to routine antenatal education, pregnant women included in the experimental group will be asked to practice at least 1 mandala per day at least 5 times a week during the 6-week pregnancy education under the supervision of a researcher.
antenatal educationOther
Routine antenatal education will be given.
| Study group | Role | What they receive |
|---|---|---|
| experimental group/mandala painting | Experimental | Mandala painting will be done in addition to routine antenatal education. Receives: Other: mandala painting; Other: antenatal education |
| antenatal education class | No intervention | Only routine antenatal education will be done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wijma Delivery Expectancy/ Experience Questionnaire Version A (W-DEQ-A)
It was developed to measure the fear of childbirth. Turkish validity and reliability were done. The scale consists of 33 items. In this scale, there are questions about labor pains and how the birth will be, how they will feel, the feelings when the baby is born, and thoughts about the birth within a month. The answers in the scale are in six-point Likert type numbered from 0 to 5. 0 is evaluated as "totally" and 5 as "not at all". The lowest score obtained from the scale is 0 and the highest score is 165. Wijma Delivery Expectancy/ Experience Questionnaire Version A scores are evaluated over four subgroups. These; Those with low level of fear of childbirth (Wijma-A score ≤ 37), those with moderate fear of childbirth (Wijma-A score between 38-65), those with severe fear of childbirth (Wijma- A scale score 66-84), and those with a clinical degree of fear of childbirth living (Wijma-A scale score ≥ 85).
Measured: 6 monts
Wijma Birth Expectation/Experience Scale (W-DEQ) version B:
It was developed to measure the fear of childbirth. The scale consists of 32 items. The answers in the scale are numbered from 0 to 5 and are in a six-point Likert type. 0 means "totally" and 5 as "not at all". While the minimum score on the scale is 0, the maximum score is 160. As the score increases, the fear of childbirth experienced by women increases. Questions 2, 3, 6, 7, 10, 11, 14, 18, 19, 23, 24, 26, 30 are calculated by turning them in the opposite direction. The scale, which was adapted into Turkish and validated and reliable, has six sub-dimensions.
Measured: It is recommended to be administered at least 2 hours after birth and within 15 days at the latest.
Birth Experience Scale
It is a scale specific to the birth experience, developed for screening purposes and improving the psychological dimension of birth. Birth Experience Scale assesses parents' perceptions of stress, pain, control, fear, and support during childbirth. It is recommended that this evaluation be done in the hospital within 1-2 days immediately after birth. Higher scores indicate a more negative birth experience.
Measured: within 1-2 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217368
- Sponsor's protocol ID
- 886
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Topcu T, Bingol FB. Mandala as a New Intervention for Reducing Fear of Childbirth: A Randomized Controlled Trial. J Midwifery Womens Health. 2025 May-Jun;70(3):414-421. doi: 10.1111/jmwh.13722. Epub 2024 Dec 11.
PubMed 39663544
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Mandala Studies on Fear of Birth Outcomes in Primiparous Pregnant
- ClinicalTrials.gov ID
- NCT05217368
- Acronym / sponsor ID
- 886
- Conditions
- Fear of Childbirth
- Keywords
- Mandala, Pregnancy, Primiparous, Antenatal Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 1 Feb 2022 (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.
Fear experienced at the time of birth and after birth is considered as fear of childbirth. If the fear occurred before pregnancy or if the pregnancy increases the severity of the fear, this can lead to "Tocophobia". When the literature is examined; In addition to birth preparation education, different methods such as cognitive behavioral theory, analytical theory, psychodrama, haptotherapy and art therapy groups have been found to be effective in reducing fear of birth. No study has been found in the literature on the effect of mandala on fear of birth and birth outcomes. By reducing the women's fear of childbirth of this study; It is predicted that it will reduce the need for medical intervention at birth, increase the normal birth rate, have a more positive birth experience and contribute to the well-being of postpartum women.
Detailed description
This research was planned as a randomized controlled study to determine the effect of mandala studies on fear of labor and delivery results in primiparous pregnant women. We will work with pregnant women who accept to participate in the study among the pregnant women who applied to the online birth and baby preparation training program at the Istanbul Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital Pregnancy Training Center. Since this research was planned experimentally, a power analysis was applied considering the number of pregnant women who applied to the pregnant school of the hospital where the research was conducted in 2020 in order to determine the number of people to be included in each group.( Akın et al. 2018) Sample size, 80% power, 0.05 margin of error, When calculated using the G*Power (3.0.10) Program with an effect level of 0.5, it was determined that at least 48 pregnant women should be recruited for each of the experimental and control groups. Considering that there may be a loss of participants during the study process, it is planned to include 75 pregnant women in both groups, and a total of 150 pregnant women are planned to be included in the study. Randomization of the experimental (n=75) and control (n=75) groups will be provided by the research randomizer.org program.In the study, an introductory information form and Wijma Birth Expectation/Experience (W-DEQ A) scale will be given to the pregnant women who applied to the birth and baby preparation training program to determine the level of fear of birth. Pregnant women with a score of 38 or more will be informed about the subject and invited to the study. During the interview, address and contact information will be obtained from the participants in order to be able to communicate. The forms required for the follow-up of the pregnant women included in the experimental and control groups will be sent to the addresses of the participants by courier in printed form and they will be asked to send them back. In addition to the routine pregnant training, the pregnant women included in the experimental group, at least 5 times a week during the 6 weeks of pregnancy training under the supervision of researcher Tuğba Topcu. They will be asked to do at least 1 mandala work per day. The same mandala study box will be given to each pregnant woman in order to ensure standardization in the pregnant women included in the experimental group. At the end of the training, the researcher Tuğba Topcu will apply the Wijma Birth Expectation/Experience scale to the experimental and control groups in order to determine the level of fear of birth. Postpartum Follow-up Form will be used at the end of delivery, Wijma Birth Expectation/Experience Scale (W DEQ) and Birth Experience Scale will be used to determine the level of birth fear experienced by pregnant women.
Statistical analysis Statistical analysis of the data will be done by using the Statistical Package for the Social Sciences (SPSS) package program and consulting a statistics expert. Apart from the individual characteristics of the individuals included in the study, whether the Wijma Birth Expectation/Experience Scale-Version A, Postpartum Follow-up Chart, Wijma Birth Expectation/Experience Scale-B Version and Birth Experience Scale total scores show a normal distribution; Shapiro Wilks test will be used, if it is found to be normally distributed, mean ± standard deviation will be given as descriptive statistics, and if it is not normally distributed, median (median) and width between quarters values will be given. In the comparison of individual characteristics and scale scores, Independent Sample T test will be applied in independent groups in those with normal distribution, Mann-Whitney U test in independent groups that do not show normal distribution, Paired-Sample T test in dependent groups with normal distribution, and Wilcoxon test in dependent groups that do not show normal distribution.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group/mandala painting | Experimental | Other: mandala painting, Other: antenatal educationMandala painting will be done in addition to routine antenatal education. |
| antenatal education class | No intervention | –Only routine antenatal education will be done. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Those who want to participate in the study voluntarily,
- Able to speak and understand Turkish,
- Living with his wife,
- Over 18 years old,
- Primiparous pregnant women
Key exclusion criteria (4 listed)
- Absence from the 6-week pregnant school for more than one week,
- Less than 30 mandala exercises over 6 weeks those who do,
- Filling in the survey forms incompletely,
- Those who develop any health problems during pregnancy will be excluded from the study.
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 |
|---|---|---|
| mandala paintingIn addition to routine antenatal education, pregnant women included in the experimental group will be asked to practice at least 1 mandala per day at least 5 times a week during the 6-week pregnancy education under the supervision of a researcher. | Other | experimental group/mandala painting |
| antenatal educationRoutine antenatal education will be given. | Other | experimental group/mandala painting |
Primary outcome
Wijma Delivery Expectancy/ Experience Questionnaire Version A (W-DEQ-A)
Time frame: 6 monts
It was developed to measure the fear of childbirth. Turkish validity and reliability were done. The scale consists of 33 items. In this scale, there are questions about labor pains and how the birth will be, how they will feel, the feelings when the baby is born, and thoughts about the birth within a month. The answers in the scale are in six-point Likert type numbered from 0 to 5. 0 is evaluated as "totally" and 5 as "not at all". The lowest score obtained from the scale is 0 and the highest score is 165. Wijma Delivery Expectancy/ Experience Questionnaire Version A scores are evaluated over four subgroups. These; Those with low level of fear of childbirth (Wijma-A score ≤ 37), those with moderate fear of childbirth (Wijma-A score between 38-65), those with severe fear of childbirth (Wijma- A scale score 66-84), and those with a clinical degree of fear of childbirth living (Wijma-A scale score ≥ 85).
Wijma Birth Expectation/Experience Scale (W-DEQ) version B:
Time frame: It is recommended to be administered at least 2 hours after birth and within 15 days at the latest.
It was developed to measure the fear of childbirth. The scale consists of 32 items. The answers in the scale are numbered from 0 to 5 and are in a six-point Likert type. 0 means "totally" and 5 as "not at all". While the minimum score on the scale is 0, the maximum score is 160. As the score increases, the fear of childbirth experienced by women increases. Questions 2, 3, 6, 7, 10, 11, 14, 18, 19, 23, 24, 26, 30 are calculated by turning them in the opposite direction. The scale, which was adapted into Turkish and validated and reliable, has six sub-dimensions.
Birth Experience Scale
Time frame: within 1-2 days after delivery
It is a scale specific to the birth experience, developed for screening purposes and improving the psychological dimension of birth. Birth Experience Scale assesses parents' perceptions of stress, pain, control, fear, and support during childbirth. It is recommended that this evaluation be done in the hospital within 1-2 days immediately after birth. Higher scores indicate a more negative birth experience.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Derived from this study: PubMed 39663544Topcu T, Bingol FB. Mandala as a New Intervention for Reducing Fear of Childbirth: A Randomized Controlled Trial. J Midwifery Womens Health. 2025 May-Jun;70(3):414-421. doi: 10.1111/jmwh.13722. Epub 2024 Dec 11.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mandala painting and antenatal education 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 10 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fadime Bayrı Bingöl (05066828524, fadimebayri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wijma Delivery Expectancy/ Experience Questionnaire Version A (W-DEQ-A) (time frame: 6 monts). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05217368, which also lists 1 linked publication.
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 21 Feb 2022.