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临床试验/NCT06955962
NCT06955962Enrolling By Invitation不适用

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

Karadeniz Technical University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
70
试验地点
2
主要终点
Quality of life of patient with MS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • Have no prior experience with mandala practice
  • Not currently participating in any form of art therapy
  • Have no communication or perception impairments

排除标准

  • 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

结局指标

主要结局

Quality of life of patient with MS

时间窗: 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.

次要结局

  • Symptom evaluation of patient with MS(6 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Müge TEZEL

Research assistant

Karadeniz Technical University

研究点 (2)

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