Mandala Coloring for Pain, Fatigue, and Sleep in Patients With Fibromyalgia

NCT07733739 | Not Yet Recruiting

• 1 other identifier: ACU-FM-MANDALA-2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pain Intensity Assessed by the Visual Analog Scale at 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.

  Baseline and end of week 4

Secondary Outcomes (2)

• 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

Study Arms (2)

Mandala Coloring Group

EXPERIMENTAL

Participants will complete eight supervised mandala coloring sessions over four weeks, with two 60-minute sessions per week. Colored pencils and a coloring booklet containing mandala patterns will be provided. Participants will continue receiving their routine treatment throughout the study.

Other: Mandala Coloring

Control Group

NO INTERVENTION

Participants will continue receiving their routine treatment for four weeks and will not participate in any structured mandala coloring activity during the study period.

Interventions

Mandala Coloring OTHER

Participants will complete eight supervised mandala coloring sessions over four weeks. Sessions will be conducted twice weekly, and each session will last 60 minutes. Participants will use colored pencils and a coloring booklet containing mandala patterns while continuing their routine treatment.

Mandala Coloring Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Artvin Coruh University: lead

Study Sites (1)

Artvin State Hospital

Artvin, Switzerland

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 17, 2027
• Study Completion (Estimated): August 17, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-06

Locations

CH (1)