Mandala Coloring for Pain, Fatigue, and Sleep in Patients With Fibromyalgia | NCT07733739

NCT07733739

Overview

NCT ID: NCT07733739
Lead Sponsor: Artvin Coruh UniversityOTHER
Official Title: The Effect of Mandala Coloring on Pain, Fatigue, and Sleep Quality in Patients With Fibromyalgia
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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Aug 17, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 60Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Artvin State Hospital

Similar Studies

Participant Group/Arms

Mandala Coloring GroupExperimental

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 GroupNo 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.