Effectiveness of a Mindfulness-Based Intervention for Pain Management in Patients With Multiple Sclerosis (MPIMS).

Официальное название

Effectiveness of a Mindfulness-Based Intervention for Pain Management in Patients With Multiple Sclerosis

Обзор

The goal of this clinical trial is to evaluate whether a mindfulness-based intervention is effective for reducing pain in adults with multiple sclerosis. It will also assess whether this intervention improves other symptoms commonly associated with pain, such as fatigue, sleep disturbances, anxiety, depression, and quality of life. The main questions it aims to answer are: * Does a mindfulness-based intervention reduce pain intensity in people with multiple sclerosis? * Does the intervention improve fatigue, sleep quality, emotional well-being, quality of life? * Does the effectiveness of the intervention differ according to the type of pain experienced by participants? Researchers will compare a mindfulness-based intervention with an educational program to determine whether mindfulness provides additional benefits for pain management in people with multiple sclerosis. Participants will: * Be randomly assigned to either the mindfulness intervention group or the educational control group. * Complete assessments before the intervention, immediately after the intervention, and at 1-month and 3-month follow-up visits. * If assigned to the mindfulness group, attend eight weekly 2.5-hour group sessions plus one 6-hour retreat, either in person or online. * If assigned to the control group, attend two 2-hour educational sessions during the study period. * Complete questionnaires evaluating pain, fatigue, physical function, anxiety, depression, sleep quality, quality of life, and mindfulness throughout the study.

Вмешательства

• Другое Mindfulness-based intervention
  Group-based mindfulness intervention specifically designed for pain management in people with multiple sclerosis. The program includes pain neuroscience education, cognitive pain management strategies, guided meditation, active visualization techniques, mindfulness-based stretching exercises, and mindful yoga.The intervention consists of eight weekly group sessions lasting 2.5 hours each, followed by a 6-hour mindfulness retreat. Participants may attend the sessions either in person or online.
• Другое Educational intervention
  Educational intervention consists of two 2-hour group sessions on multiple sclerosis and pain management, delivered once every 4 weeks during the 8-week intervention period.

Первичные конечные точки

• Intensity of pain [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
• Dimensions of pain [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
• Impact of pain on daily functioning [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
• Presence of neuropathic pain [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
• Emotional and cognitive impact of pain [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
• Severity of pain [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]

Вторичные конечные точки (9)

• Physical function [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
• Fatigue [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
• Depressive symptoms [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
• Anxiety [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
• Sleep disturbance [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
• Health-Related Quality of Life [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
• Mindfulness [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
• Sleep quality [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]
• Dispositional mindfulness [Срок оценки: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.]

Критерии участия

Критерии включения

• Adults aged 18 to 80 years.
• Diagnosis of multiple sclerosis with an Expanded Disability Status Scale (EDSS) score between 1.0 and 7.0.
• Presence of pain.
• Ability to provide written informed consent.

Критерии исключения

• Severe cognitive impairment.
• Diagnosed psychiatric disorders (e.g., schizophrenia or personality disorders).
• Participation in another non-pharmacological intervention specifically aimed at pain management.
• If receiving stable pain medication, treatment must have been maintained for at least 4 months before enrollment.
• Unwillingness to provide 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

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hopsital Universitario Virgen Macarena — Seville

Публикации

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Идентификаторы

NCT: NCT07741864 · SICEIA-2025-002466

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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