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Набор скоро начнётся NCT07733739

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

Без фазы С лечением Fibromyalgia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mandala Coloring.
Кому может быть актуально
Состояния в реестре: Fibromyalgia. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
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Официальное название

The Effect of Mandala Coloring on Pain, Fatigue, and Sleep Quality in Patients With Fibromyalgia

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Mandala Coloring
    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.

Первичные конечные точки

  • Change From Baseline in Pain Intensity Assessed by the Visual Analog Scale at Week 4 [Срок оценки: Baseline and end of week 4]
Вторичные конечные точки (2)
  • Change From Baseline in Fatigue Severity Assessed by the Fatigue Severity Scale at Week 4 [Срок оценки: Baseline and end of week 4]
  • Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index at Week 4 [Срок оценки: Baseline and end of week 4]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Швейцария · 1 центр
  • Artvin State Hospital — Artvin

Идентификаторы

NCT: NCT07733739 · ACU-FM-MANDALA-2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗