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Enrolling by invitation NCT06955962

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

No phase Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mandala Art Therapy.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Quality of life of patient with MS [Time frame: 6 week]
Secondary outcome measures (1)
  • Symptom evaluation of patient with MS [Time frame: 6 week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Karadeniz Technical University — Trabzon

Identifiers

NCT: NCT06955962 · MTEZEL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗