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

NCT06955962 | Enrolling By Invitation

• 1 other identifier: MTEZEL
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; mandala art therapy; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Symptom evaluation of patient with MS

  6 week

Study Arms (2)

Control Group

NO INTERVENTION

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)."

Intervention Group

EXPERIMENTAL

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

Interventions

Mandala Art Therapy OTHER

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

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, 61040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nesrin NURAL, Prof

  Karadeniz Technical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: May 2, 2025
• Study Start: May 10, 2025
• Primary Completion: July 10, 2025
• Study Completion: August 30, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)