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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05773482
Status
Recruiting
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Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Breathing and Attention Training (BAT) — BEHAVIORAL
    BAT is an instructor guided breathing technique over 20 min that will be applied once in a training session and approximately one week later in a testing session.
  • Breathing Control — BEHAVIORAL
    Controlled Breathing (without mindfulness) is an instructor guided breathing technique over 20 min that will be applied once in a training session and approximately one week later in a testing session.

Study Details

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.

Key Dates

Start date
Apr 3, 2023
Status verified
Jun 2025
Primary completion
Mar 9, 2027
Completion
Mar 9, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 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).
  • Active Comparator: Controlled Deep Breathing
    Participants will be asked to do 20-minutes of deep breathing and letting the body relax.

Primary Outcome Measure

Ratings of Painful and Painless Sensory Stimuli [ Time Frame: 2 hr ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Melyssa Godfrey
[email protected]
352-265-8901
Roland Staud, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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