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

Effects of Breathing and Attention Training (BAT) on Pain Modulation in Healthy Individuals and Patients With Chronic Musculoskeletal Pain

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05773482
Enrollment
40
Registered
2023-03-17
Start date
2023-04-03
Completion date
2028-03-09
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

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.

Interventions

BEHAVIORALBreathing 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.

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.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Participants who do not receive BAT will be asked to perform deep breathing without mindfulness.

Intervention model description

This parallel study will be age & sex matched, and randomized.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Ratings of Painful and Painless Sensory Stimuli2 hrRatings 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.

Countries

United States

Contacts

CONTACTMelyssa Godfrey
painresearch@medicine.ufl.edu352-265-8901
CONTACTRoland Staud, MD
PRINCIPAL_INVESTIGATORRoland Staud, MD

University of Florida

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026