the Effect of Mandala Studies on Fear of Birth Outcomes in Primiparous Pregnant
1 other identifier
interventional
150
1 country
1
Brief 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". 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
January 21, 2022
CompletedFirst Posted
Study publicly available on registry
February 1, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedFebruary 21, 2022
January 1, 2022
8 months
January 21, 2022
February 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
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.
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.
within 1-2 days after delivery
Study Arms (2)
experimental group/mandala painting
EXPERIMENTALMandala painting will be done in addition to routine antenatal education.
antenatal education class
NO INTERVENTIONOnly routine antenatal education will be done.
Interventions
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.
Routine antenatal education will be given.
Eligibility Criteria
You may qualify if:
- 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,
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marmara University
Istanbul, 34854, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 39663544DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2022
First Posted
February 1, 2022
Study Start
April 1, 2022
Primary Completion
December 1, 2022
Study Completion
January 31, 2023
Last Updated
February 21, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share