Art TherapyNCT06727045
The Effect of Mandala Art Therapy on Comfort Level in Patients Receiving HD Treatment
A study testing Mandala Coloring in people with Art Therapy and Mandala Painting, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effect of mandala painting on the comfort level of patients receiving HD treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Art Therapy, Mandala Painting, Hemodialysis Patients
- What is being tested?
- Mandala Coloring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2023to 15 Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18-65
- Those with no communication problems
- Those who can understand and speak Turkish
- Those who have been receiving HD treatment for at least three months
- Those who have been receiving HD three times a week
- Those who have no visual impairment
- Those who do not have any problems affecting fine motor function in the upper extremities (such as rheumatoid arthritis)
- Those who volunteered to participate in the study were included in the study
Who cannot join
- Patients with arteriovenous fistula in the dominant arm
- Patients who had previously undergone mandala application were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Damla dialysis center
Gaziantep, Şehitkamil, 27000
About this study
Official title: The Effect of Mandala Art Therapy on Comfort Level in Patients Receiving Hemodialysis Treatment
This study was conducted to evaluate the effect of mandala painting on the comfort level of patients receiving HD treatment.
Read the detailed description
The number of patients diagnosed with end-stage renal disease (ESRD) is constantly increasing and the most common method used in the treatment of these patients is hemodialysis (HD). HD is the process of passing the blood taken from the patient through the HD device, regulating fluid and electrolytes, and cleaning waste products such as urea. The aim of this process is to prevent complications, strengthen self-care, and thus increase the patient's quality of life and ensure their comfort. However, patients who receive HD treatment have to deal with various problems. This situation negatively affects the comfort of the HD patient. In addition, many factors such as constantly going to a dialysis center for the HD procedure, restriction of movements during the HD session, and disruption of work harmony and social relationships reduce the comfort of the patients. Therefore, ensuring the comfort of the HD patient is very important. A number of integrative methods are recommended to increase comfort. One of these methods, mandala, is effectively used in the field of art therapy. Mandala, which has a long history and represents integrity, is a Sanskrit word that means "circle" or completion and increases the individual's personal awareness. According to art psychotherapists, mandala painting is one of the main tools of other art psychotherapy techniques that focus on healing. Mindfulness-based activities such as drawing or painting mandalas allow the person to keep their attention in the "moment", make sense of what they have MINIMIDAted, increase their well-being and feel more comfortable. Mandala, which is a concentration method, helps the person stay in the moment. Energy and emotions can also change with the effects of the colors used. It is also emphasized that mandala painting contributes to symptom management, can be used in all age groups and has a positive effect on the treatment process of different diseases and disorders. The natural calming effect of mandala on the mind and body not only strengthens the desire to heal, but also helps the person get rid of psychological fragmentation. In line with these data, it is thought that activities such as mandala can be effective in HD patients who are faced with a large number of stress factors. Therefore, the effect of mandala painting on the comfort level of patients receiving HD treatment was evaluated in this study.
- Conditions
- Art Therapy, Mandala Painting, Hemodialysis Patients
- Being tested
- Mandala Coloring
- Keywords
- Hemodialysis, Nursing, Comfort, Mandala Painting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala ColoringOther
A literature review was conducted to determine the frequency and number of mandalas to be applied to the patients in the intervention group, and the average of the number of mandala sessions applied to different patient groups was obtained, and mandala application was performed during a total of eight hemodialysis sessions, every other day. Mandala painting was performed approximately 30 minutes after the start of HD treatment, considering the art therapist's recommendation and the symptoms that may develop during HD. Each mandala painting was performed with a structured and different mandala pattern. Since it was stated that the use of round patterns instead of square patterns was effective in increasing the comfort level, the booklet called "Mandala Booklet", consisting of 8 structured mandala patterns with round shapes and containing general information about mandala, was used in the study. The group was informed about the content of the booklet face to face. Dry pencils were prefer
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Questionnaire and Hemodialysis Comfort Scale Version-II (HDKS-II) were applied to the patients. Patients were randomised to groups. A literature review was conducted for the frequency and number of mandalas to be applied to the patients in the intervention group, and mandalas were applied during eight hemodialysis sessions every other day. Mandala painting was done approximately 30 minutes after the start of HD treatment, considering the art therapist's suggestion and the symptoms that may develop during HD. Each mandala painting was performed with a structured and different mandala pattern. In the study, a booklet called the "Mandala Booklet" consisting of eight structured mandala patterns with round shapes and containing general information about mandalas was used. The patients in the intervention group were informed face to face about the content of the booklet. At the end of the 17th day, the Hemodialysis Comfort Scale-Version II was applied to the group again. Receives: Other: Mandala Coloring |
| Control Group | No intervention | Questionnaire and Hemodialysis Comfort Scale Version-II (HDKS-II) were applied to the patients. Randomization of the patients to the groups was done by a statistician other than the researcher with a computer program (www.randomizer.org) and was done by taking into account age, gender and comfort scale scores. No application was made to the patients in the control group. The booklet was given to the patients in the control group after the mandala coloring was completed. At the end of the 17th day, Hemodialysis Comfort Scale-Version II was applied to the group again. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodialysis Comfort Scale Version-II
Due to the insufficient number of items in the previously developed Hemodialysis Comfort Scale, Koşar and colleagues developed the Hemodialysis Comfort Scale-Version II (HDKÖ-II) scale and its validity and reliability study was conducted by the same authors. The scale consists of 26 items and the responses to the items were prepared in a five-point Likert type as never, very rarely, sometimes, very often, always. The scale has six sub-dimensions as physical relief, physical relaxation, psychospiritual relaxation, psychospiritual empowerment, environmental empowerment, and sociocultural relaxation. Although there are reverse and direct scored items in the scale, the number of reverse scored items is high. As the score obtained from the scale increases, the patient's comfort also increases.
Measured: At the beginning and at the end of the 17th day
Secondary outcomes (1)
Question Form
The questionnaire form was created by the researchers in line with the literature. Questions 1-11 of this form include a total of 21 questions, questioning the descriptive characteristics of the patients, questions 12-21 questioning the HD treatment and the emotions felt by the patients during the treatment.
Measured: At the beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start29 Dec 2023
- Primary completion18 Mar 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Art TherapyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Groups (intervention-control) were determined by the minimization method by recording the scores obtained from age, gender and comfort performance.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gül Kırıcı, Sanko University
- Investigators
- Nimet Ovayolu, Prof. Dr., Study director, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727045
- Sponsor's protocol ID
- SU-DON-GK-01
- Status last verified
- Mar 2025
- First submitted
- 5 Dec 2024
- Last updated
- 12 Mar 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Art Therapy on Comfort Level in Patients Receiving Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT06727045
- Acronym / sponsor ID
- SU-DON-GK-01
- Conditions
- Art Therapy, Mandala Painting, Hemodialysis Patients
- Keywords
- Hemodialysis, Nursing, Comfort, Mandala Painting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 29 Dec 2023 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 10 Dec 2024 (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 study was conducted to evaluate the effect of mandala painting on the comfort level of patients receiving HD treatment.
Detailed description
The number of patients diagnosed with end-stage renal disease (ESRD) is constantly increasing and the most common method used in the treatment of these patients is hemodialysis (HD). HD is the process of passing the blood taken from the patient through the HD device, regulating fluid and electrolytes, and cleaning waste products such as urea. The aim of this process is to prevent complications, strengthen self-care, and thus increase the patient's quality of life and ensure their comfort. However, patients who receive HD treatment have to deal with various problems. This situation negatively affects the comfort of the HD patient. In addition, many factors such as constantly going to a dialysis center for the HD procedure, restriction of movements during the HD session, and disruption of work harmony and social relationships reduce the comfort of the patients. Therefore, ensuring the comfort of the HD patient is very important. A number of integrative methods are recommended to increase comfort. One of these methods, mandala, is effectively used in the field of art therapy. Mandala, which has a long history and represents integrity, is a Sanskrit word that means "circle" or completion and increases the individual's personal awareness. According to art psychotherapists, mandala painting is one of the main tools of other art psychotherapy techniques that focus on healing. Mindfulness-based activities such as drawing or painting mandalas allow the person to keep their attention in the "moment", make sense of what they have MINIMIDAted, increase their well-being and feel more comfortable. Mandala, which is a concentration method, helps the person stay in the moment. Energy and emotions can also change with the effects of the colors used. It is also emphasized that mandala painting contributes to symptom management, can be used in all age groups and has a positive effect on the treatment process of different diseases and disorders. The natural calming effect of mandala on the mind and body not only strengthens the desire to heal, but also helps the person get rid of psychological fragmentation. In line with these data, it is thought that activities such as mandala can be effective in HD patients who are faced with a large number of stress factors. Therefore, the effect of mandala painting on the comfort level of patients receiving HD treatment was evaluated in this study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Groups (intervention-control) were determined by the minimization method by recording the scores obtained from age, gender and comfort performance.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Mandala ColoringQuestionnaire and Hemodialysis Comfort Scale Version-II (HDKS-II) were applied to the patients. Patients were randomised to groups. A literature review was conducted for the frequency and number of mandalas to be applied to the patients in the intervention group, and mandalas were applied during eight hemodialysis sessions every other day. Mandala painting was done approximately 30 minutes after the start of HD treatment, considering the art therapist's suggestion and the symptoms that may develop during HD. Each mandala painting was performed with a structured and different mandala pattern. In the study, a booklet called the "Mandala Booklet" consisting of eight structured mandala patterns with round shapes and containing general information about mandalas was used. The patients in the intervention group were informed face to face about the content of the booklet. At the end of the 17th day, the Hemodialysis Comfort Scale-Version II was applied to the group again. |
| Control Group | No intervention | –Questionnaire and Hemodialysis Comfort Scale Version-II (HDKS-II) were applied to the patients. Randomization of the patients to the groups was done by a statistician other than the researcher with a computer program (www.randomizer.org) and was done by taking into account age, gender and comfort scale scores. No application was made to the patients in the control group. The booklet was given to the patients in the control group after the mandala coloring was completed. At the end of the 17th day, Hemodialysis Comfort Scale-Version II was applied to the group again. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged between 18-65
- Those with no communication problems
- Those who can understand and speak Turkish
- Those who have been receiving HD treatment for at least three months
- Those who have been receiving HD three times a week
Key exclusion criteria (2 listed)
- Patients with arteriovenous fistula in the dominant arm
- Patients who had previously undergone mandala application were excluded from the study.
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 ColoringA literature review was conducted to determine the frequency and number of mandalas to be applied to the patients in the intervention group, and the average of the number of mandala sessions applied to different patient groups was obtained, and mandala application was performed during a total of eight hemodialysis sessions, every other day. Mandala painting was performed approximately 30 minutes after the start of HD treatment, considering the art therapist's recommendation and the symptoms that may develop during HD. Each mandala painting was performed with a structured and different mandala pattern. Since it was stated that the use of round patterns instead of square patterns was effective in increasing the comfort level, the booklet called "Mandala Booklet", consisting of 8 structured mandala patterns with round shapes and containing general information about mandala, was used in the study. The group was informed about the content of the booklet face to face. Dry pencils were prefer | Other | Intervention Group |
Primary outcome
Hemodialysis Comfort Scale Version-II
Time frame: At the beginning and at the end of the 17th day
Due to the insufficient number of items in the previously developed Hemodialysis Comfort Scale, Koşar and colleagues developed the Hemodialysis Comfort Scale-Version II (HDKÖ-II) scale and its validity and reliability study was conducted by the same authors. The scale consists of 26 items and the responses to the items were prepared in a five-point Likert type as never, very rarely, sometimes, very often, always. The scale has six sub-dimensions as physical relief, physical relaxation, psychospiritual relaxation, psychospiritual empowerment, environmental empowerment, and sociocultural relaxation. Although there are reverse and direct scored items in the scale, the number of reverse scored items is high. As the score obtained from the scale increases, the patient's comfort also increases.
1 secondary outcome
Question Form
Time frame: At the beginning
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 12 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Art Therapy
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 2
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
HIV, Heavy Drinking
Not yet recruiting
Expressive Arts Therapy in Major Depression: An RCT
Depression - Major Depressive Disorder
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.
Nimet Ovayolu, Prof. Dr. study director
Sanko University
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 Art Therapy and Mandala Painting, run by Sanko 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 8 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 12 Mar 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?
Hemodialysis Comfort Scale Version-II (time frame: At the beginning and at the end of the 17th day). 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 12 Mar 2025.