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

Not Applicable

• Conditions: Multiple Sclerosis

• Registration Number: NCT06955962
• Lead Sponsor: Karadeniz Technical University

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.

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-30
• Study First Posted: 2025-05-02
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Study Start: 2025-05-10
• Primary Completion: 2025-07-10
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of life of patient with MS	6 week	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.

Secondary Outcome Measures

Name	Time	Method
Symptom evaluation of patient with MS	6 week	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.

Trial Locations

Locations (1)

Karadeniz Technical University; 🇹🇷 Trabzon, Turkey