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Completed

NCT Number: NCT04720053

Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients

The purpose of this study is to study the feasibility of a wearable brain sensing wellness device to provide mindfulness training to fibromyalgia patients who have failed medical therapy.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

All study participants will receive a wearable brain sensing wellness device, and demonstration of the mindfulness sessions. Participants will be asked to complete study surveys/questionnaires. During the first part of study, participants will be asked to complete the intervention. After completion of the intervention they will enter a follow-Up Phase, where they will be contacted and asked to complete surveys and gauge satisfaction with the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older at time of consent.
  • Diagnosed with Fibromyalgia.
  • Not pregnant by subject self-report at time of consent.
  • Have the ability to provide informed consent.
  • Have the ability to complete all aspects of this trial.
  • Have access to a iPhone, iPad, Android device.
  • Has no contraindicating comorbid health condition as determined by the clinical investigators.

Exclusion criteria

  • Used or been enrolled in any treatments for fibromyalgia, or pain within the past 30 days.
  • Used an investigational drug within the past 30 days.
  • Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
  • Currently (within the past 3 weeks) been undergoing an additional program (e.g. CAM) to improve quality of life.
  • Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, or stress.
  • An unstable medical or mental health condition as determined by the physician investigator.

Treatment and study plan

Wearable brain sensing wellness device headband system

Device

Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.

Primary outcomes

  1. Change in Widespread Pain Index (WPI)

    Time frame: Baseline to end of treatment (day 90)

    Wide pain index (WPI) defined as a 4-quadrant plus axial pain, measuring widespread pain in 19 body areas where the patient feels pain over the prior week. Each area identified on the list counts as 1. The range on the WPI score can range from 0 to 19. With lower number indicating fewer areas of pain (hence lower pain). The difference is calculated by taking the baseline score minus the end of treatment score.

  2. Change in Perceived Stress Scale

    Time frame: Baseline to end of treatment (day 90)

    Measured on a 0-10 pain assessment scale. Participants rate their stress on a scale of 0 to 10. Zero means "no stress," and 10 means "the worst possible stress". The difference is calculated by taking the baseline score minus the end of treatment score.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Feasibility Study Evaluating Mindfulness-Based Intervention Assessing- A Wearable Wellness Brain Sensing Device (Muse-S) in Newly Diagnosed Fibromyalgia Patients.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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