Mandala Coloring for Pain, Fatigue, and Sleep in Patients With Fibromyalgia
ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArtvin Coruh University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mandala Coloring
BehavioralParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Mandala Coloring GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline and end of week 4Secondary outcomes
1
Change From Baseline in Fatigue Severity Assessed by the Fatigue Severity Scale at Week 4
Fatigue will be assessed using the nine-item Fatigue Severity Scale. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), and the total score is calculated as the mean of the nine items. Scores range from 1 to 7, with higher scores indic
Time frame
Baseline and end of week 42
Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index at Week 4
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A global score of 5 or higher indicates poor sleep quality. The outcome will be evaluated as the change in the global score from baseline to the end of week 4.
Time frame
Baseline and end of week 4Sponsors and contacts
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Source ClinicalTrials.gov