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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Mandala Coloring
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanko University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 29, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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