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Mandala-Based Intervention in Pregnancy: A Randomized Controlled Trial

ConditionsPerception of Traumatic ChildbirthPsychological ResilienceBehavioral Emotion Regulation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorSakarya University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Mandala-Based

    Behavioral

    Eight 45-minute mandala-based sessions over four weeks, delivered twice weekly.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention

Secondary outcomes

1

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.

Time frame
Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention
2

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.

Time frame
Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sakarya University

Lead sponsor

Bartın Unıversity

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: