Perception of Traumatic ChildbirthNCT07855289
Mandala-Based Intervention in Pregnancy
A study testing Mandala-Based in people with Perception of Traumatic Childbirth and Psychological Resilience, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
This study will examine whether a mandala-based coloring program affects pregnant women's perceptions of traumatic childbirth, behavioral emotion regulation, and psychological resilience. Pregnant women aged 18 to 49 years will be randomly assigned to a mandala intervention group or a control group. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perception of Traumatic Childbirth, Psychological Resilience, Behavioral Emotion Regulation
- What is being tested?
- Mandala-Based
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18 and 49,
- Being in the 1st, 2nd, or 3rd trimester,
- Volunteering to participate in the study,
- Completing the forms in full,
Who cannot join
- Having a diagnosis of a high-risk pregnancy,
- Not wishing to continue with the study,
- Experiencing communication difficulties (not knowing Turkish, or having hearing, speech, or comprehension impairments),
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bartın University
Bartın, Bartın, 74100
Güleser ADA, PhD, gada@bartin.edu.tr
About this study
Official title: The Effect of a Mandala-Based Intervention on Traumatic Childbirth Perception, Behavioral Emotion Regulation, and Psychological Resilience in Pregnant Women: A Randomized Controlled Trial
This study will examine whether a mandala-based coloring program affects pregnant women's perceptions of traumatic childbirth, behavioral emotion regulation, and psychological resilience. Pregnant women aged 18 to 49 years will be randomly assigned to a mandala intervention group or a control group.
Participants in the intervention group will attend eight 45-minute sessions over four weeks (two sessions per week). Sessions will include brief preparation and breathing exercises, mandala coloring, and a short discussion. The control group will receive no study intervention. Participants in both groups will complete questionnaires before the intervention, immediately afterward, and at one-month and three-month follow-up assessments. Researchers will compare changes in the groups' questionnaire scores.
Read the detailed description
This is a two-arm, parallel-group randomized controlled study with assessments before the intervention, immediately after the intervention, and at one-month and three-month follow-up. The study will be conducted with pregnant women attending antenatal education services in Bartın, Türkiye.
Eligible participants will be randomly allocated to the intervention or control group using a randomization sequence prepared by a person who is not involved in the study. Because of the nature of the intervention, participants and intervention providers cannot be blinded.
The mandala-based program consists of eight sessions delivered twice weekly over four weeks. Each session lasts approximately 45 minutes: a five-minute introduction and breathing exercise, 35 minutes of themed mandala coloring, and five minutes for participants to reflect on their experience. Session themes address present-moment awareness, adjustment to bodily changes, personal strengths, hope, motherhood, preparation for childbirth, and integration of the program experience. The control group will not receive the study intervention.
The study will assess perceived traumatic childbirth using the Perception of Traumatic Childbirth Scale, behavioral emotion regulation using the Behavioral Emotion Regulation Questionnaire, and psychological resilience using the Brief Resilience Scale. These measures will be administered to both groups at baseline, immediately after the four-week intervention period, and at one and three months after the intervention.
- Conditions
- Perception of Traumatic Childbirth, Psychological Resilience, Behavioral Emotion Regulation
- Being tested
- Mandala-Based
- Keywords
- Pregnancy, Mandala Coloring, Antenatal Care, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala-BasedBehavioural
Eight 45-minute mandala-based sessions over four weeks, delivered twice weekly.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Eight 45-minute mandala-based sessions over four weeks, delivered twice weekly. Receives: Behavioral: Mandala-Based |
| control | No intervention | Participants will receive no study intervention. Outcome assessments will be performed at the same time points as in the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perception of Traumatic Childbirth Scale score
The 13-item Perception of Traumatic Childbirth Scale measures anticipated traumatic childbirth perception. Total scores range from 0 to 130; higher scores indicate a stronger perception of traumatic childbirth. Change from baseline will be compared between groups.
Measured: Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention
Secondary outcomes (2)
Change in Behavioral Emotion Regulation Questionnaire subscale scores
The 20-item Behavioral Emotion Regulation Questionnaire assesses five behavioral strategies: seeking distraction, withdrawal, actively approaching, seeking social support, and ignoring. Items are rated from 1 to 5. Higher subscale scores indicate more frequent use of the corresponding strategy. Changes in subscale scores will be compared between groups.
Measured: Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention
Change in Brief Resilience Scale score
The 6-item Brief Resilience Scale assesses psychological resilience. Items are rated from 1 to 5, with items 2, 4, and 6 reverse-coded. Higher scores indicate greater psychological resilience. Change from baseline will be compared between groups.
Measured: Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perception of Traumatic ChildbirthStudies of the same condition, open and under way.
- 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
- Model description
- experimental and control group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÜLESER ADA, Bartın Unıversity
- Investigators
- Güleser ADA, PhD, Principal investigator, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855289
- Sponsor's protocol ID
- BARU-SBF-MANDALA-2026
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Mandala-Based Intervention on Traumatic Childbirth Perception, Behavioral Emotion Regulation, and Psychological Resilience in Pregnant Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07855289
- Acronym / sponsor ID
- BARU-SBF-MANDALA-2026
- Conditions
- Perception of Traumatic Childbirth, Psychological Resilience, Behavioral Emotion Regulation
- Keywords
- Pregnancy, Mandala Coloring, Antenatal Care, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 Oct 2026 (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 will examine whether a mandala-based coloring program affects pregnant women's perceptions of traumatic childbirth, behavioral emotion regulation, and psychological resilience. Pregnant women aged 18 to 49 years will be randomly assigned to a mandala intervention group or a control group.
Participants in the intervention group will attend eight 45-minute sessions over four weeks (two sessions per week). Sessions will include brief preparation and breathing exercises, mandala coloring, and a short discussion. The control group will receive no study intervention. Participants in both groups will complete questionnaires before the intervention, immediately afterward, and at one-month and three-month follow-up assessments. Researchers will compare changes in the groups' questionnaire scores.
Detailed description
This is a two-arm, parallel-group randomized controlled study with assessments before the intervention, immediately after the intervention, and at one-month and three-month follow-up. The study will be conducted with pregnant women attending antenatal education services in Bartın, Türkiye.
Eligible participants will be randomly allocated to the intervention or control group using a randomization sequence prepared by a person who is not involved in the study. Because of the nature of the intervention, participants and intervention providers cannot be blinded.
The mandala-based program consists of eight sessions delivered twice weekly over four weeks. Each session lasts approximately 45 minutes: a five-minute introduction and breathing exercise, 35 minutes of themed mandala coloring, and five minutes for participants to reflect on their experience. Session themes address present-moment awareness, adjustment to bodily changes, personal strengths, hope, motherhood, preparation for childbirth, and integration of the program experience. The control group will not receive the study intervention.
The study will assess perceived traumatic childbirth using the Perception of Traumatic Childbirth Scale, behavioral emotion regulation using the Behavioral Emotion Regulation Questionnaire, and psychological resilience using the Brief Resilience Scale. These measures will be administered to both groups at baseline, immediately after the four-week intervention period, and at one and three months after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- experimental and control group
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Mandala-BasedEight 45-minute mandala-based sessions over four weeks, delivered twice weekly. |
| control | No intervention | –Participants will receive no study intervention. Outcome assessments will be performed at the same time points as in the intervention group. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being between the ages of 18 and 49,
- Being in the 1st, 2nd, or 3rd trimester,
- Volunteering to participate in the study,
- Completing the forms in full,
Key exclusion criteria (3 listed)
- Having a diagnosis of a high-risk pregnancy,
- Not wishing to continue with the study,
- Experiencing communication difficulties (not knowing Turkish, or having hearing, speech, or comprehension impairments),
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-BasedEight 45-minute mandala-based sessions over four weeks, delivered twice weekly. | Behavioural | Experimental group |
Primary outcome
Change in Perception of Traumatic Childbirth Scale score
Time frame: Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention
The 13-item Perception of Traumatic Childbirth Scale measures anticipated traumatic childbirth perception. Total scores range from 0 to 130; higher scores indicate a stronger perception of traumatic childbirth. Change from baseline will be compared between groups.
2 secondary outcomes
Change in Behavioral Emotion Regulation Questionnaire subscale scores
Time frame: Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention
Change in Brief Resilience Scale score
Time frame: Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Laughter Yoga's Impact on Traumatic Childbirth Preparation
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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.
Güleser ADA, PhD principal investigator
Bartın Unıversity
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-Based in people with Perception of Traumatic Childbirth and Psychological Resilience, run by Sakarya 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Güleser ADA, PhD (538-450-85-47, gada@bartin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perception of Traumatic Childbirth Scale score (time frame: Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention). 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 14 Oct 2026.