Clinical trial NCT06955962: Examining the Effect of Mandala Art Therapy on Symptoms and Quality of Life in Multiple Sclerosis Patients
Official title: Examining the Effect of Mandala Art Therapy on Symptoms and Quality of Life in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
mandala art therapy
quality of life
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Quality of life of patient with MS
timeFrame: 6 week
Secondary outcomes:
measure: Symptom evaluation of patient with MS
timeFrame: 6 week
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
affiliation: Karadeniz Technical University
name: Nesrin NURAL, Prof
role: STUDY_DIRECTOR
References: