Status:
COMPLETED
Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients
Lead Sponsor:
Mayo Clinic
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2023
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04720053
Start Date
November 1 2021
End Date
July 28 2023
Last Update
September 3 2024
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905