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

Not Applicable

Recruiting

• Conditions: Fibromyalgia
• Interventions: Behavioral: Breathing and Attention Training (BAT); Behavioral: Breathing Control

• Registration Number: NCT05773482
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-17
• Study Start: 2023-04-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28
• Primary Completion: 2027-03-09
• Study Completion: 2028-03-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breathing and Attention Training (BAT)	Breathing and Attention Training (BAT)	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).
Controlled Deep Breathing	Breathing Control	Participants will be asked to do 20-minutes of deep breathing and letting the body relax.

Primary Outcome Measures

Name	Time	Method
Ratings of Painful and Painless Sensory Stimuli	2 hr	Ratings of painful and non-painful stimuli in FM subjects and HC will be obtained before and after BAT or Deep Breathing. Painful stimuli will include pressure stimuli. Painless stimuli will consist of flashing light stimuli.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States