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Mindfulness Meditation for Fibromyalgia
N/A
Recruiting
Led By Roland Staud, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hr
Awards & highlights
No Placebo-Only Group
Summary
This trial will evaluate how Breathing Attention Training (a form of mindfulness meditation) affects pain sensitivity in those with fibromyalgia. Results from testing brain areas & complex methods are too expensive, so quantitative sensory testing will be used.
Who is the study for?
This trial is for adults with fibromyalgia, a condition causing widespread pain, who've had symptoms for over 6 months and meet specific diagnostic criteria. Healthy individuals without chronic pain can also join as controls. Participants must stop taking certain medications like painkillers and antidepressants before the study.
What is being tested?
The study tests Breathing and Attention Training (BAT), a type of mindfulness meditation that may reduce fibromyalgia symptoms and sensitivity to pain. It's compared against standard breathing control techniques using quantitative sensory testing to measure effects on pain modulation.
What are the potential side effects?
Since BAT involves non-invasive mindfulness practices, significant side effects are not expected. However, participants might experience temporary discomfort or emotional distress during meditation sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hr
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hr
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ratings of Painful and Painless Sensory Stimuli
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Breathing and Attention Training (BAT)Experimental Treatment1 Intervention
Participants will be asked to do 20-minutes of focused breathing and attention training, involving focusing on taking deep breaths and becoming aware of the changing body sensations associated with breathing (mindfulness).
Group II: Controlled Deep BreathingActive Control1 Intervention
Participants will be asked to do 20-minutes of deep breathing and letting the body relax.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,397 Previous Clinical Trials
767,020 Total Patients Enrolled
Roland Staud, MDPrincipal InvestigatorUniversity of Florida
4 Previous Clinical Trials
403 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to stop taking my pain, sleep, anxiety, or depression meds for the study.I am healthy, of similar age, and do not suffer from chronic pain.I or someone in my family has epilepsy triggered by lights.I have been diagnosed with fibromyalgia and have had pain for more than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Breathing and Attention Training (BAT)
- Group 2: Controlled Deep Breathing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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