The Effect of Mandala Coloring in Type-2 Diabetes Patients
1 other identifier
interventional
92
1 country
1
Brief Summary
THIS RESEARCH was planned to examine the effect of mandala painting on the perceived stress and anxiety levels of type-2 diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
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
October 5, 2023
CompletedFirst Posted
Study publicly available on registry
October 11, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 14, 2025
February 1, 2025
6 months
October 5, 2023
February 12, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Perceived Stress Scale
The Perceived Stress Scale was developed by Cohen, Kamarck and Mermelstein in 1983 to determine the level of stress that threatens human health. Turkish validity and reliability were determined by Eskin et al. (2013). The scale is a 5-point Likert type scale and consists of 14 items. As the scores obtained from the scale increase, the level of stress perceived by the person also increases. PSS scores vary between 0 and 56, with 0-35 points indicating normal stress level and 35-56 points indicating that the individual is under stress.
after 7 days
State-Trait Anxiety Scale
The State-Trait Anxiety Scale was developed by Spielberger et al. (1970). The validity and reliability of the scale in Turkey was determined by Öner and Le Compte (1983). The scale consists of two parts: State Anxiety Scale and Trait Anxiety Scale. The first 20 items evaluate situational anxiety, and the last 20 items evaluate trait anxiety. In this study, the scores obtained from the Scale, which is the first 20 items to evaluate situation-related anxiety, range between 20 and 80. Higher scores indicate higher levels of anxiety.
after 7 days
Study Arms (2)
Experimental:mandala painting
EXPERIMENTALPatients in this group will be subjected to mandala painting.
Control
NO INTERVENTIONPatients in this group will not be subjected to mandala painting.
Interventions
Patients in this group will be subjected to mandala painting.
Eligibility Criteria
You may qualify if:
- Being between the ages of 18 and 65
- Having been diagnosed with Type-2 diabetes for at least 6 months
- Being an inpatient in the endocrine clinic for at least 7 days
- Not having a physical problem that would prevent painting mandalas (vision, hearing, etc.)
You may not qualify if:
- Not being able to use his hands actively
- Having a communication problem
- Having a learning problem
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Firat University
Elâzığ, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 5, 2023
First Posted
October 11, 2023
Study Start
December 1, 2023
Primary Completion
May 25, 2024
Study Completion
December 1, 2024
Last Updated
February 14, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share