Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients
NCT ID: NCT04720053
Last Updated: 2024-09-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2021-11-01
2023-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Wearable brain sensing wellness device headband system
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.
Wearable brain sensing wellness device headband system
Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.
Interventions
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Wearable brain sensing wellness device headband system
Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Sanjeev Nanda
Principal Investigator
Principal Investigators
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Sanjeev Nanda, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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20-003020
Identifier Type: -
Identifier Source: org_study_id
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