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

NCT07741864

Not Yet RecruitingNA

Sponsor: Hospital Universitario Virgen Macarena

Conditions: Multiple Sclerosis, Pain, Pain Management

Interventions: Mindfulness-based intervention, Educational intervention

Countries: Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
Locations (1)
  • Seville, Sevilla, Spain