The Effect of Mandala Art Therapy on Comfort Level in Patients Receiving HD Treatment

NCT06727045 | Completed

• 1 other identifier: SU-DON-GK-01
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to evaluate the effect of mandala painting on the comfort level of patients receiving HD treatment.

Conditions

Art Therapy; Mandala Painting; Hemodialysis Patients

Keywords

Hemodialysis; Nursing; Comfort; Mandala Painting

Outcome Measures

Primary Outcomes (1)

• 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.

  At the beginning and at the end of the 17th day

Secondary Outcomes (1)

• Question Form

  At the beginning

Study Arms (2)

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.

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.

Interventions

Mandala Coloring OTHER

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with arteriovenous fistula in the dominant arm
• Patients who had previously undergone mandala application were excluded from the study.

Sponsors & Collaborators

• Sanko University: lead

Study Sites (1)

Private Damla dialysis center

Gaziantep, Şehitkamil, 27000, Turkey (Türkiye)

Location

Study Officials

• Nimet Ovayolu, Prof. Dr.

  Sanko University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The minimization method was used to determine the patients in the intervention and control groups included in the research sample, and the random distribution of patients to the groups was made by a statistician other than the researcher using a computer program (www.randomizer.org) and taking into account age, gender, and scores from the comfort scale.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Groups (intervention-control) were determined by the minimization method by recording the scores obtained from age, gender and comfort performance.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: December 29, 2023
• Primary Completion: March 18, 2024
• Study Completion: April 15, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)