Dialysismandala and HDNCT07004088
The Effect of Mandala Coloring on Symptom Burden and Self-Care in Female Dialysis Patients
A study testing Mandala coloring in people with Dialysis and Symptoms, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
In kidney patients, especially the continuous dialysis treatment can cause symptoms which adversely affect patients' self-care abilities and quality of life. T Nonpharmacological methods can be used to reduce low and moderate symptoms. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- What is being tested?
- Mandala coloring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2024to 30 Jan 2025
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years or older
- Able to communicate adequately
- No psychiatric problems
- No vision problems
- Receiving hemodialysis treatment for at least 6 months
- Willing and able to provide informed consent to participate in the study
Who cannot join
- Hemodialysis patients younger than 18 years of age
- Patients with physical or psychological limitations that interfere with -participation
Trial locations and contacts
1 site in 1 country.
About this study
In kidney patients, especially the continuous dialysis treatment can cause symptoms which adversely affect patients' self-care abilities and quality of life. T Nonpharmacological methods can be used to reduce low and moderate symptoms. Mandala is one of the non-pharmacological approaches and is used in many areas with its therapeutic properties.
In the literature review on the effect of mandala application on dialysis patients symptoms and self care, no research was found. The aim of this study was to determine the effect of mandala coloring on dialysis symptoms and self-care of female patients receiving hemodialysis treatment.
Read more
Data were collected by using personal information form, Dialysis Symptom Index Scale, Self-Care Power Scale for Chronic Dialysis Patients.
As an intervention tool, a circular mandala and 12 felt paint were used in the study.
Study was designed as a randomized control study Intervention Group; voluntary consent form, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled. One hour after the start of each dialysis session, the patients were given mandalas for 20-30 minutes and asked to paint. After the sixth dialysis session , the patients were asked to refill the scales with one-on-one interviews, and the verbal opinions and feedback of the patients about the application were taken.
Control Group; Female patients undergoing dialysis treatment in the dialysis unit were informed about the study. Volunteer consent form, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled. After the sixth dialysis session, the women were asked to refill the scales.
- Being tested
- Mandala coloring
- Keywords
- dialysis, symptom index, self care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala coloringBehavioural
Female patients undergoing dialysis treatment in the dialysis unit were informed about the study. After women are informed about the effects of mandala application on health and how to paint mandala; voluntary consent form, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled. One hour after the start of each dialysis session, the patients were given mandalas for 20-30 minutes and asked to paint. The women's own paints and mandalas were preserved for the next session. After the sixth dialysis session , the patients were asked to refill the scales with one-on-one interviews, and the verbal opinions and feedback of the patients about the application were taken.
| Study group | Role | What they receive |
|---|---|---|
| Mandala group | Experimental | Female patients undergoing dialysis treatment in the dialysis unit were given mandalas for 20-30 minutes and asked to paint during 6 dialysis session, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled before and after the sixth dialysis session, t Receives: Behavioral: Mandala coloring |
| Control Group | No intervention | Female patients undergoing dialysis treatment in the dialysis unit were informed about the study. Volunteer consent form, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled at the beginning and after the sixth dialysis session |
What is being measured
The primary outcome is the main question the study is designed to answer.
dialysis related symptom
Dialysis Symptom Index (DSI); The Dialysis Symptom Index (DSI) was developed by Weisbord et al. (2005) to determine the symptoms experienced by HD patients and the level of impact on patients. The Turkish reliability and validity of the scale was made by Önsöz and Yeşilbalkan (2013) and Cronbach's alpha value was reported as 0.84. DSI identifies 30 symptoms, either physical or emotional. In DSI, the symptoms experienced in the last week are answered as yes-no, and if the answer is yes, the extent to which the symptoms affected the patients who answered "yes" was evaluated as 0 = no, 1 = none, 2 = some, 3 = sometimes, 4 = very little, 5 = too much. The total scale score is obtained by adding the obtained scores. The score of the scale ranges from 0-150. The fact that the answers given to the scale increased towards 150 points indicates that the effect of the symptom in question increased. The internal consistency coefficient of the scale was determined as 0.84 (Usta, 2013).
Measured: After voluntary consent is obtained, the scale filled in by interviewing the patients one-on-one before the mandala painting attempt begins. 4 weeks after the completion of the mandala colouring the scale replenished
Self-Care Agency Scale for Patients on Long-Term Dialysis
The scale was developed by Besey Ören in 2010 for HD and peritoneal dialysis patients. The Self-Care Agency Scale is an easily understandable, 22-item, 3-point Likert-type scale. The items are scored as follows: 0=I always apply, 1=I sometimes apply, and 2=I do not apply at all. It was created for people to express their status of applying selfcare habits in their daily lives. The patient is asked to choose the most appropriate option for him. The total score obtainable from the tool ranges between 0 and 44. Subscale scores are obtained by summing the item scores under each subscale. Accordingly, scores obtainable from the subscales are 0-12 for the use of medicine, 0-10 for diet, 0-8 for self-monitoring, 0-4 for hygienic care, and 0-6 for mental state. It shows that as the score obtained from the scale decreases, self-care ability decreases.16 The α coefficient of the scale was 0.67.
Measured: After voluntary consent is obtained, the scale filled in by interviewing the patients one-on-one before the mandala painting attempt begins. 4 weeks after the completion of the mandala colouring the scale replenished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start10 Sep 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies of the same condition, open and under way.
- 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
- randomized controlled study
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Aydin, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004088
- Sponsor's protocol ID
- 29.05.2024/03.06.2024
- Acronym
- mandala and HD
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring on Symptom Burden and Self-Care in Female Dialysis Patients
- ClinicalTrials.gov ID
- NCT07004088
- Acronym / sponsor ID
- mandala and HD / 29.05.2024/03.06.2024
- Keywords
- dialysis, symptom index, self care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 4 Jun 2025 (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.
In kidney patients, especially the continuous dialysis treatment can cause symptoms which adversely affect patients' self-care abilities and quality of life. T Nonpharmacological methods can be used to reduce low and moderate symptoms. Mandala is one of the non-pharmacological approaches and is used in many areas with its therapeutic properties.
In the literature review on the effect of mandala application on dialysis patients symptoms and self care, no research was found. The aim of this study was to determine the effect of mandala coloring on dialysis symptoms and self-care of female patients receiving hemodialysis treatment.
Data were collected by using personal information form, Dialysis Symptom Index Scale, Self-Care Power Scale for Chronic Dialysis Patients.
As an intervention tool, a circular mandala and 12 felt paint were used in the study.
Study was designed as a randomized control study Intervention Group; voluntary consent form, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled. One hour after the start of each dialysis session, the patients were given mandalas for 20-30 minutes and asked to paint. After the sixth dialysis session , the patients were asked to refill the scales with one-on-one interviews, and the verbal opinions and feedback of the patients about the application were taken.
Control Group; Female patients undergoing dialysis treatment in the dialysis unit were informed about the study. Volunteer consent form, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled. After the sixth dialysis session, the women were asked to refill the scales.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Mandala group | Experimental | Behavioral: Mandala coloringFemale patients undergoing dialysis treatment in the dialysis unit were given mandalas for 20-30 minutes and asked to paint during 6 dialysis session, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled before and after the sixth dialysis session, t |
| Control Group | No intervention | –Female patients undergoing dialysis treatment in the dialysis unit were informed about the study. Volunteer consent form, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled at the beginning and after the sixth dialysis session |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients aged 18 years or older
- Able to communicate adequately
- No psychiatric problems
- No vision problems
- Receiving hemodialysis treatment for at least 6 months
Key exclusion criteria (2 listed)
- Hemodialysis patients younger than 18 years of age
- Patients with physical or psychological limitations that interfere with -participation
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 coloringFemale patients undergoing dialysis treatment in the dialysis unit were informed about the study. After women are informed about the effects of mandala application on health and how to paint mandala; voluntary consent form, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled. One hour after the start of each dialysis session, the patients were given mandalas for 20-30 minutes and asked to paint. The women's own paints and mandalas were preserved for the next session. After the sixth dialysis session , the patients were asked to refill the scales with one-on-one interviews, and the verbal opinions and feedback of the patients about the application were taken. | Behavioural | Mandala group |
Primary outcome
dialysis related symptom
Time frame: After voluntary consent is obtained, the scale filled in by interviewing the patients one-on-one before the mandala painting attempt begins. 4 weeks after the completion of the mandala colouring the scale replenished
Dialysis Symptom Index (DSI); The Dialysis Symptom Index (DSI) was developed by Weisbord et al. (2005) to determine the symptoms experienced by HD patients and the level of impact on patients. The Turkish reliability and validity of the scale was made by Önsöz and Yeşilbalkan (2013) and Cronbach's alpha value was reported as 0.84. DSI identifies 30 symptoms, either physical or emotional. In DSI, the symptoms experienced in the last week are answered as yes-no, and if the answer is yes, the extent to which the symptoms affected the patients who answered "yes" was evaluated as 0 = no, 1 = none, 2 = some, 3 = sometimes, 4 = very little, 5 = too much. The total scale score is obtained by adding the obtained scores. The score of the scale ranges from 0-150. The fact that the answers given to the scale increased towards 150 points indicates that the effect of the symptom in question increased. The internal consistency coefficient of the scale was determined as 0.84 (Usta, 2013).
Self-Care Agency Scale for Patients on Long-Term Dialysis
Time frame: After voluntary consent is obtained, the scale filled in by interviewing the patients one-on-one before the mandala painting attempt begins. 4 weeks after the completion of the mandala colouring the scale replenished
The scale was developed by Besey Ören in 2010 for HD and peritoneal dialysis patients. The Self-Care Agency Scale is an easily understandable, 22-item, 3-point Likert-type scale. The items are scored as follows: 0=I always apply, 1=I sometimes apply, and 2=I do not apply at all. It was created for people to express their status of applying selfcare habits in their daily lives. The patient is asked to choose the most appropriate option for him. The total score obtainable from the tool ranges between 0 and 44. Subscale scores are obtained by summing the item scores under each subscale. Accordingly, scores obtainable from the subscales are 0-12 for the use of medicine, 0-10 for diet, 0-8 for self-monitoring, 0-4 for hygienic care, and 0-6 for mental state. It shows that as the score obtained from the scale decreases, self-care ability decreases.16 The α coefficient of the scale was 0.67.
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 4 Jun 2025.
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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 coloring in people with Dialysis and Symptoms, run by Atlas 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 6 inclusion and 2 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 4 Jun 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?
dialysis related symptom (time frame: After voluntary consent is obtained, the scale filled in by interviewing the patients one-on-one before the mandala painting attempt begins. 4 weeks after the completion of the mandala colouring the scale replenished). 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 4 Jun 2025.