- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07420413
Effects of Mandala Coloring in Missed Abortion
The Effect of Mandala Coloring Activity on Stress, Anxiety, Pain and Physiological Parameters in Women Diagnosed With Missed Abortion: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Missed abortion is a distressing pregnancy loss experience that may lead to increased anxiety, stress, and emotional burden in affected women. In addition to psychological distress, acute stress responses may also influence physiological parameters such as heart rate, blood pressure, oxygen saturation, and body temperature. Supportive, non-pharmacological interventions may help reduce emotional and physical discomfort during hospitalization.
Mandala coloring is a structured, repetitive art-based activity that may promote relaxation and emotional regulation. It is considered a simple, low-cost, and non-invasive supportive intervention that can be easily implemented in clinical settings.
This randomized controlled trial is designed to evaluate the effectiveness of mandala coloring activity in women diagnosed with missed abortion. Participants are randomly assigned to either a mandala coloring group receiving the intervention in addition to standard care, or a control group receiving standard care alone. The mandala session lasts a minimum of 30 minutes and is conducted during hospitalization.
Stress, state anxiety, and pain levels, along with physiological parameters (heart rate, blood pressure, oxygen saturation, and body temperature), are assessed at baseline (hospital admission) and immediately after completion of the intervention. The study aims to determine whether mandala coloring contributes to improved psychological well-being and physiological stability in women experiencing pregnancy loss.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rukiye Arslantaş
- Phone Number: MSc +905379671005
- Email: rukiyearslantas96@gmail.com
Study Contact Backup
- Name: Bihter Akın, PhD
- Phone Number: +05056703228
- Email: bihterakin@yahoo.com
Study Locations
-
-
Selçuklu
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Konya, Selçuklu, Turkey (Türkiye), 42250
- Recruiting
- Konya City Hospital
-
Contact:
- Bihter Akın, PhD
- Phone Number: +05056703228
- Email: bihterakin@yahoo.com
-
Contact:
- Rukiye Arslantaş, Msc
- Phone Number: 05379671005
- Email: rukiyearslantas96@gmail.com
-
Principal Investigator:
- Rukiye Arslantaş, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 18 years and older
- Hospitalized with a diagnosis of missed abortion
Gestational age of 10 weeks or less
Mentally healthy and able to communicate
Able to read, understand, and speak Turkish
Literate
Willing to participate and provide written informed consent
ExcluPhysical limitations preventing participation in the coloring activity
History of previous pregnancy loss
Presence of chronic medical disease
Diagnosis of a psychiatric disordersion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mandala Coloring Group
Participants receive mandala coloring activity in addition to standard care during hospitalization.
|
Participants engage in a structured mandala coloring activity session during hospitalization in addition to standard care.
The activity is conducted individually in a quiet environment.
|
|
No Intervention: Control Group
Participants receive standard care only during hospitalization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in State Anxiety Score
Time Frame: At hospital admission (baseline) and immediately after completion of the mandala coloring session (minimum 30 minutes) during hospitalization
|
State anxiety will be measured using the State Anxiety Inventory (STAI-State).
The primary outcome is the change in anxiety score from baseline at hospital admission to immediately after completion of the mandala coloring session during hospitalization.
Higher scores indicate greater anxiety.
|
At hospital admission (baseline) and immediately after completion of the mandala coloring session (minimum 30 minutes) during hospitalization
|
|
Change in Perceived Stress Score
Time Frame: At hospital admission (baseline) and immediately after completion of the mandala coloring session (minimum 30 minutes) during hospitalization
|
Perceived stress will be measured using the Perceived Stress Scale (PSS).
The secondary outcome is the change in stress score from baseline at hospital admission to immediately after completion of the mandala coloring session during hospitalization.
Higher scores indicate greater perceived stress.
|
At hospital admission (baseline) and immediately after completion of the mandala coloring session (minimum 30 minutes) during hospitalization
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rukiye Arslantaş, MSc, Selcuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-EC-2025/1049
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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