The Effect of Mandala Coloring on Pain, Fatigue, and Sleep Quality in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change From Baseline in Pain Intensity Assessed by the Visual Analog Scale at Week 4
研究概览
简要总结
Fibromyalgia is a chronic condition commonly associated with widespread pain, fatigue, and poor sleep quality. This randomized controlled study aims to determine whether mandala coloring, when added to routine treatment, improves pain, fatigue, and sleep quality in adults with fibromyalgia.
A total of 60 eligible participants will be randomly assigned in a 1:1 ratio to either a mandala coloring group or a control group. Participants in the mandala coloring group will complete eight 60-minute coloring sessions over four weeks, with two sessions per week, while continuing their routine treatment. Participants in the control group will continue their routine treatment without taking part in a structured coloring activity.
Pain, fatigue, and sleep quality will be assessed at the beginning of the study and at the end of the fourth week. Changes in these outcomes will be compared between the two groups.
详细描述
This is a single-center, two-arm, parallel-group randomized controlled trial designed to evaluate the effects of mandala coloring on pain, fatigue, and sleep quality in adults with fibromyalgia. The study will be conducted in the Physical Medicine and Rehabilitation Outpatient Clinic of Artvin State Hospital.
Sixty participants who meet the eligibility criteria will be enrolled. Following the baseline assessment, participants will be randomly assigned in a 1:1 ratio to the mandala coloring group or the control group using a simple randomization method.
Participants assigned to the intervention group will receive colored pencils and a coloring booklet containing mandala patterns. They will complete eight supervised mandala coloring sessions over four weeks. The sessions will be conducted twice weekly, and each session will last approximately 60 minutes. Participants will continue receiving their routine treatment throughout the study.
Participants assigned to the control group will continue their routine treatment and will not participate in any structured mandala coloring activity during the four-week study period.
Outcome assessments will be performed at baseline and at the end of week 4. Pain intensity will be assessed using the Visual Analog Scale for Pain, fatigue will be assessed using the Fatigue Severity Scale, and sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Changes in outcome scores will be compared within and between the study groups.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Diagnosed with fibromyalgia
- •Pain intensity score of 5 or higher on the Visual Analog Scale
- •Fatigue Severity Scale score of 4 or higher
- •Pittsburgh Sleep Quality Index global score of 5 or higher
- •Able to communicate and complete the study assessments
- •No physical limitation preventing mandala coloring
- •Willing to participate and provide written informed consent
排除标准
- •Presence of a communication problem that prevents participation or completion of the assessments
- •Presence of a physical limitation that prevents mandala coloring
- •Refusal to participate or provide written informed consent
结局指标
主要结局
Change From Baseline in Pain Intensity Assessed by the Visual Analog Scale at Week 4
时间窗: Baseline and end of week 4
Pain intensity will be assessed using a 10-cm Visual Analog Scale, ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. The outcome will be evaluated as the change in the Visual Analog Scale score from baseline to the end of week 4.
次要结局
- Change From Baseline in Fatigue Severity Assessed by the Fatigue Severity Scale at Week 4(Baseline and end of week 4)
- Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index at Week 4(Baseline and end of week 4)
研究者
EMRE ERKAL
Dr
Artvin Coruh University