Examining the Effect of Mandala Art Therapy on Symptoms and Quality of Life in Multiple Sclerosis Patients

This study is a randomized controlled, pre-test-post-test experimental research aimed at examining the effects of mandala art therapy on symptom severity and quality of life in individuals diagnosed with Multiple Sclerosis (MS). The main goal is to determine whether mandala art therapy helps reduce the frequency and severity of MS symptoms while improving participants' overall quality of life.

It is expected that mandala art therapy will support MS patients in managing current and potential symptoms, coping more effectively with the disease, and improving adherence to treatment. As a result, a reduction in healthcare utilization, related costs, MS-related complications, and mortality is anticipated.

The study will be conducted between May and August 2025 at the Neurology Outpatient Clinic of Karadeniz Technical University Practice and Research Center, involving 70 patients-35 in the intervention group receiving mandala art therapy and 35 in the control group receiving standard care.

Study Overview

• Status: Enrolling by invitation
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Mandala Art Therapy

Detailed Description

This study was designed as a randomized controlled, pre-test-post-test experimental research to examine the effects of mandala art therapy on symptom severity and quality of life in individuals diagnosed with Multiple Sclerosis (MS). The primary objective of the study is to evaluate whether the implementation of mandala art therapy contributes to a reduction in the frequency and severity of MS-related symptoms, while simultaneously enhancing the overall quality of life of the participants.

In this context, it is anticipated that mandala art therapy may support individuals with MS in managing existing and potential symptoms, coping more effectively with the disease, and achieving better adherence to treatment and disease management. Consequently, it is expected that the frequency of healthcare utilization and overall healthcare-related costs will decrease. Most importantly, a reduction in MS-related complications and mortality is also anticipated.

The planned study will be conducted between May 2025 and August 2025 at the Neurology Outpatient Clinic of the Karadeniz Technical University Practice and Research Center, involving a total of 70 patients-35 in the intervention group and 35 in the control group-who meet the inclusion criteria. While patients in the intervention group will receive mandala art therapy, those in the control group will continue their routine follow-up and treatment without any additional intervention.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Trabzon, Turkey, 61040
    • Karadeniz Technical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Residing in the city center of Trabzon
• Diagnosed with Multiple Sclerosis at least six months prior
• Have not experienced an MS relapse within the past three months
• Receiving outpatient treatment for MS
• Literate
• Have no prior experience with mandala practice
• Not currently participating in any form of art therapy
• Have no communication or perception impairments

Exclusion Criteria:

• Those who have experienced an MS relapse within the past three months
• Those receiving inpatient treatment for MS
• Individuals aged 18 years or younger
• Those with a physical disability that prevents them from participating in the mandala activity
• Individuals currently engaged in any form of active art therapy
• Those with communication or perception impairments
• Individuals with a diagnosed psychiatric disorder
• Those who cannot be reached via phone and/or text message
• Individuals with allergies to materials used in the mandala therapy sessions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; In the study, no intervention will be applied to individuals in the control group during their visits to the neurology outpatient clinic; they will continue with their routine follow-up, examinations, and treatment as usual. Pre-tests will be administered to participants in the control group who agree to take part in the study, have been informed about its purpose, scope, duration, and methodology, and have provided both written and verbal consent. These pre-tests will include the "Descriptive Information Form," the "Multiple Sclerosis Symptom Scale (MS-RS)," and the "Multiple Sclerosis Quality of Life Scale (MSQL-54)." At the end of six weeks, participants will be contacted via telephone to schedule an appointment for the administration of post-tests. The post-tests to be applied to the control group will again include the "Descriptive Information Form," the "Multiple Sclerosis Symptom Scale (MS-RS)," and the "Multiple Sclerosis Quality of Life Scale (MSQL-54)."
Experimental: Intervention Group; The mandala art therapy for individuals in the intervention group is planned to be conducted in their home environments under suitable conditions. The therapy sessions will be accompanied by music of the participants' choosing and are scheduled to take place over a six-week period, at least three to four times per week, for a minimum of 30 minutes per session.	Other: Mandala Art Therapy; Arm Description: The mandala art therapy for individuals in the intervention group is planned to be conducted in their home environments under suitable conditions. The therapy sessions will be accompanied by music of the participants' choosing and are scheduled to take place over a six-week period, at least three to four times per week, for a minimum of 30 minutes per session. Before the first mandala art therapy session, participants in the intervention group will receive a brief orientation by the researcher on the appropriate environment for the practice and an introduction to mandala art therapy. This orientation will include information on the definition and characteristics of mandala art therapy, the application setting and duration, and general guidelines to be followed during the sessions. At the end of the six-week mandala art therapy program, Post-tests ill be administered face-to-face, and the archived mandala folders will be collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of patient with MS	The quality of life of patient with MS will be defined by using Multiple Sclerosis Quality of Life Scale (MSQL-54). The scale scores range from 0 to 100, and as the score increases, the quality of life of individuals increases.	6 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom evaluation of patient with MS	Symptom evaluation of patient with MS will be defined by using Multiple Sclerosis Symptom Scale (MS-RS) The minimum score that can be obtained from the scale is 0, the maximum score is 130, with higher scores indicating increased symptom burden.	6 week

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Investigators: Study Director: Nesrin NURAL, Prof, Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2025
• Primary Completion (Estimated): July 10, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 30, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; multiple sclerosis; mandala art therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: MTEZEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This thesis study is currently ongoing and has not yet been completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No