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Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wearable brain sensing wellness device headband system
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Wearable brain sensing wellness device headband system

Arm Description

Subject diagnosed with fibromyalgia at Mayo Clinic GIM Fibromyalgia Clinic will receive a wearable brain sensing wellness device headband system, and will be given a demonstration of the mindfulness sessions, with detailed instructions on how to begin each session.

Outcomes

Primary Outcome Measures

Change in wide pain index (WPI)
Wide pain index (WPI) defined as a 4-quadrant plus axial pain, measuring widespread pain in 19 specific places on both sides of the body, above and below the waist
Change in symptom severity score
Measured on a 0-10 pain assessment scale. Participants rate their pain on a scale of 0 to 10. Zero means "no pain," and 10 means "the worst possible pain".

Secondary Outcome Measures

Full Information

First Posted
January 19, 2021
Last Updated
October 13, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04720053
Brief Title
Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients
Official Title
A Feasibility Study Evaluating Mindfulness-Based Intervention Assessing- A Wearable Wellness Brain Sensing Device (Muse-S) in Newly Diagnosed Fibromyalgia Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
July 28, 2023 (Actual)
Study Completion Date
July 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wearable brain sensing wellness device headband system
Arm Type
Experimental
Arm Description
Subject diagnosed with fibromyalgia at Mayo Clinic GIM Fibromyalgia Clinic will receive a wearable brain sensing wellness device headband system, and will be given a demonstration of the mindfulness sessions, with detailed instructions on how to begin each session.
Intervention Type
Device
Intervention Name(s)
Wearable brain sensing wellness device headband system
Intervention Description
Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.
Primary Outcome Measure Information:
Title
Change in wide pain index (WPI)
Description
Wide pain index (WPI) defined as a 4-quadrant plus axial pain, measuring widespread pain in 19 specific places on both sides of the body, above and below the waist
Time Frame
Baseline, end of treatment day 90, and at the end of study day 180
Title
Change in symptom severity score
Description
Measured on a 0-10 pain assessment scale. Participants rate their pain on a scale of 0 to 10. Zero means "no pain," and 10 means "the worst possible pain".
Time Frame
Baseline, end of treatment day 90, and at the end of study day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjeev Nanda, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients

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