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

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathing and Attention Training (BAT)
Breathing Control
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fibromyalgia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Breathing and Attention Training (BAT)

Controlled Deep Breathing

Arm 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).

Participants will be asked to do 20-minutes of deep breathing and letting the body relax.

Outcomes

Primary Outcome Measures

Ratings of Painful and Painless Sensory Stimuli
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.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2023
Last Updated
May 9, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05773482
Brief Title
Effects of Breathing and Attention Training (BAT) on Pain Modulation
Official Title
Effects of Breathing and Attention Training (BAT) on Pain Modulation in Healthy Individuals and Patients With Chronic Musculoskeletal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
March 9, 2027 (Anticipated)
Study Completion Date
March 9, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This parallel study will be age & sex matched, and randomized.
Masking
Participant
Masking Description
Participants who do not receive BAT will be asked to perform deep breathing without mindfulness.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breathing and Attention Training (BAT)
Arm Type
Experimental
Arm 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).
Arm Title
Controlled Deep Breathing
Arm Type
Active Comparator
Arm Description
Participants will be asked to do 20-minutes of deep breathing and letting the body relax.
Intervention Type
Behavioral
Intervention Name(s)
Breathing and Attention Training (BAT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Breathing Control
Intervention Description
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 Information:
Title
Ratings of Painful and Painless Sensory Stimuli
Description
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.
Time Frame
2 hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melyssa Godfrey
Phone
352-265-8901
Email
painresearch@medicine.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Roland Staud, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Staud, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melyssa Godfrey
Phone
352-265-8901
Email
Melyssa.Godfrey@medicine.ufl.edu
First Name & Middle Initial & Last Name & Degree
Roland Staud, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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