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

Sponsor
Hospital Universitario Virgen Macarena
Study ID
NCT07741864
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Mindfulness-based intervention — OTHER
    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.
  • Educational intervention — OTHER
    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.

Study Details

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.

Key Dates

First listed
Aug 3, 2026
Start date
Sep 2, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mindfulness Group
    Participants will receive a Mindfulness intervention specifically designed for pain management in people with multiple sclerosis.
  • Active Comparator: Educational Group
    Participants will receive an active educational intervention for pain management consisting of two group sessions

Primary Outcome Measure

Intensity of pain [ Time Frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention. ]

Central Contacts

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