Mandala PaintingNCT06077461
The Effect of Mandala Coloring in Type-2 Diabetes Patients
A study testing mandala painting in people with Mandala Painting and Type-2 Diabetic Patients, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
THIS RESEARCH was planned to examine the effect of mandala painting on the perceived stress and anxiety levels of type-2 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandala Painting, Type-2 Diabetic Patients
- What is being tested?
- mandala painting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- Not being able to use his hands actively
- Having a communication problem
- Having a learning problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mandala Coloring on Perceived Stress and Anxiety Levels in Type-2 Diabetes Patients: Randomized Controlled Study
THIS RESEARCH was planned to examine the effect of mandala painting on the perceived stress and anxiety levels of type-2 diabetic patients.
Read the 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.
- Conditions
- Mandala Painting, Type-2 Diabetic Patients
- Being tested
- mandala painting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandala paintingBehavioural
Patients in this group will be subjected to mandala painting.
| Study group | Role | What they receive |
|---|---|---|
| Experimental:mandala painting | Experimental | Patients in this group will be subjected to mandala painting. Receives: Behavioral: mandala painting |
| Control | No intervention | Patients in this group will not be subjected to mandala painting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: after 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Dec 2023
- Primary completion25 May 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandala PaintingStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an experimental study with pre-test and post-test control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077461
- Sponsor's protocol ID
- 2023/ 12 - 41
- Status last verified
- Feb 2025
- First submitted
- 5 Oct 2023
- Last updated
- 14 Feb 2025
- 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 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring on Perceived Stress and Anxiety Levels in Type-2 Diabetes Patients: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06077461
- Acronym / sponsor ID
- 2023/ 12 - 41
- Conditions
- Mandala Painting, Type-2 Diabetic Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 11 Oct 2023 (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 RESEARCH was planned to examine the effect of mandala painting on the perceived stress and anxiety levels of type-2 diabetic patients.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is an experimental study with pre-test and post-test control groups
| Arm | Type | Receives |
|---|---|---|
| Experimental:mandala painting | Experimental | Behavioral: mandala paintingPatients in this group will be subjected to mandala painting. |
| Control | No intervention | –Patients in this group will not be subjected to mandala painting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 18 and 65
Key exclusion criteria (3 listed)
- Not being able to use his hands actively
- Having a communication problem
- Having a learning problem
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 paintingPatients in this group will be subjected to mandala painting. | Behavioural | Experimental:mandala painting |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 painting in people with Mandala Painting and Type-2 Diabetic Patients, run by Ataturk 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: finished, as of the sponsor's last update on 14 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: after 7 days). The study lists 2 primary outcomes in all. 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 Feb 2025.