- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06077461
The Effect of Mandala Coloring in Type-2 Diabetes Patients
The Effect of Mandala Coloring on Perceived Stress and Anxiety Levels in Type-2 Diabetes Patients: Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diabetes is a frequently encountered chronic metabolic disease characterized by increased plasma glucose levels as a result of inadequate insulin secretion and/or increased insulin resistance. The most common type of diabetes is type-2 diabetes, accounting for approximately 90% of all cases. Type 2 diabetes is more common in middle and older ages, but today it is also seen in children and young adults due to negative changes in lifestyle habits.
Diabetes is typically a manageable disease through lifestyle changes and treatment. However, diabetes care can create additional stress for people with diabetes due to the never-ending demands of maintaining nutritional and physical health, exercising, monitoring blood sugar, regular monitoring, and managing fears about the reality of symptoms and complications. As a result, they experience feelings of depression, anxiety, and stress, which affects their health and overall quality of life. Patients with diabetes have significantly higher levels of anxiety and depression than the general population. The coexistence of diabetes and anxiety and stress results in poor glycemic control and self-management, increases the risk of diabetes complications, and reduces overall quality of life and life expectancy. Therefore, prevention, early recognition and treatment of these conditions are necessary to achieve optimal goals in the management and overall quality of life of patients.
A holistic approach should be adopted when planning the care practices of patients during this difficult period, and non-pharmacological practices should be planned, especially those that will allow the patient to perform daily life activities with minimum energy and maximum function. Mandala painting, one of the non-pharmacological practices, is an art therapy technique that can provide psychological support and healing. This circular art has traditionally been used for meditation in various Eastern cultures and is a symbol of psychological wholeness. Mandala coloring is a safe and accessible activity that does not require any special skills and can be used as a complementary strategy to support mental health. It is stated in the literature that painting mandalas improves psychological symptoms and relaxes the person. The artistic perspective of nursing is to understand the individual's needs, sources of worry, anxiety and stress, and then to develop practices that will increase his self-confidence and resilience by increasing his level of capability and competence. For this reason, this study was planned to examine the effect of mandala painting on the perceived stress and anxiety levels of Type-2 diabetic patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Elazıg, Turkey
- Firat University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.)
Exclusion Criteria:
- Not being able to use his hands actively
- Having a communication problem
- Having a learning problem
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental:mandala painting
Patients in this group will be subjected to mandala painting.
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Patients in this group will be subjected to mandala painting.
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No Intervention: Control
Patients in this group will not be subjected to mandala painting.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale
Time Frame: after 7 days
|
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.
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after 7 days
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State-Trait Anxiety Scale
Time Frame: after 7 days
|
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.
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after 7 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 2023/ 12 - 41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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