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Effects of Breathing and Attention Training (BAT) on Pain Modulation

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University of Florida

Status

Enrolling

Conditions

Fibromyalgia

Treatments

Behavioral: Breathing Control
Behavioral: Breathing and Attention Training (BAT)

Study type

Interventional

Funder types

Other

Identifiers

NCT05773482
IRB202300172

Details and patient eligibility

About

The hypersensitivity of fibromyalgia is associated with abnormal pain modulation within the CNS, but not with peripheral or central sensitization. Many brain areas that contribute to modulation of pain are known, but their testing is complex and expensive. Quantitative sensory testing is easier to perform and repeatable. Therefore, it will be used to evaluate the effects of Breathing Attention Training (BAT) on the hypersensitivity of FM participants. BAT is a form of mindfulness meditation shown to decrease FM symptoms and possibly pain sensitivity. We hypothesize that pain modulation of chronic pain patients is improved by BAT.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Individuals diagnosed with fibromyalgia will have pain of duration > 6 months and meeting the 1990 Research Diagnostic Criteria for FM (ACR)
  • Healthy, pain-free age matched controls without chronic pain

Exclusion criteria

  • Personal or family history of photosensitive epilepsy
  • Prior history of cancer or diabetes
  • Patients must be willing to discontinue their analgesics, hypnotics, anxiolytics, or anti-depressants during the study period for at least 5 half-lives.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Breathing and Attention Training (BAT)
Experimental group
Description:
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).
Treatment:
Behavioral: Breathing and Attention Training (BAT)
Controlled Deep Breathing
Active Comparator group
Description:
Participants will be asked to do 20-minutes of deep breathing and letting the body relax.
Treatment:
Behavioral: Breathing Control

Trial contacts and locations

1

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Central trial contact

Melyssa Godfrey; Roland Staud, MD

Data sourced from clinicaltrials.gov

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