Recruiting

Breathing and Attention Training

Sponsor:

University of Florida

Code:

NCT05773482

Conditions

Fibromyalgia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Breathing and Attention Training (BAT)

Breathing Control

Study Details

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.

Conditions

Fibromyalgia

Study ID

NCT05773482

Start date

Apr 3, 2023

Status verified date

Jun, 2026

Completion date

Mar 9, 2028

Anticipated

Primary completion date

Mar 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Breathing and Attention Training (BAT)

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Melyssa Godfrey

352-265-8901painresearch@medicine.ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Melyssa Godfrey

352-265-8901Melyssa.Godfrey@medicine.ufl.edu

Principal Investigator:

Roland Staud, MD

More Information

Sponsor

University of Florida

Last update posted

Jul 6, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-06.