- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06727045
The Effect of Mandala Art Therapy on Comfort Level in Patients Receiving HD Treatment
March 8, 2025 updated by: Gül Kırıcı, Sanko University
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.
Study Overview
Status
Completed
Conditions
Intervention / 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 Type
Interventional
Enrollment (Actual)
98
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Şehitkamil
-
Gaziantep, Şehitkamil, Turkey, 27000
- Private Damla dialysis center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with arteriovenous fistula in the dominant arm
- Patients who had previously undergone mandala application were excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
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.
|
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
|
|
No Intervention: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At the beginning and at the end of the 17th day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Question Form
Time Frame: At the beginning
|
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.
|
At the beginning
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nimet Ovayolu, Prof. Dr., Sanko University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 29, 2023
Primary Completion (Actual)
March 18, 2024
Study Completion (Actual)
April 15, 2024
Study Registration Dates
First Submitted
December 5, 2024
First Submitted That Met QC Criteria
December 5, 2024
First Posted (Actual)
December 10, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 8, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SU-DON-GK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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