Mandala Coloring for Pain, Fatigue, and Sleep in Patients With Fibromyalgia
The Effect of Mandala Coloring on Pain, Fatigue, and Sleep Quality in Patients With Fibromyalgia
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Artvin, Švýcarsko
- Artvin State Hospital
-
Kontakt:
- Emre ERKAL, PhD
- Telefonní číslo: 5433750709
- E-mail: emre.erkal@artvin.edu.tr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Mandala Coloring Group
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.
|
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.
|
|
Žádný zásah: Control Group
Participants will continue receiving their routine treatment for four weeks and will not participate in any structured mandala coloring activity during the study period.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in Pain Intensity Assessed by the Visual Analog Scale at Week 4
Časové okno: 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.
|
Baseline and end of week 4
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in Fatigue Severity Assessed by the Fatigue Severity Scale at Week 4
Časové okno: Baseline and end of 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
|
Baseline and end of week 4
|
|
Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index at Week 4
Časové okno: Baseline and end of 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.
|
Baseline and end of week 4
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ACU-FM-MANDALA-2026
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .