Group Integrative Breathwork for Chronic Pain

NCT06977984 | Completed

• 1 other identifier: IRB202500383
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the proposed research is to iteratively develop, pilot test, and refine an integrative breathwork intervention that is suitable for group delivery to individuals with chronic pain. The intervention will be evaluated for feasibility, acceptability, and plausibility for clinically significant effects in people with chronic musculoskeletal pain.

Conditions

Chronic Pain

Keywords

Breathwork; Chronic Pain; Integrative Breathwork Intervention; Chronic Musculoskeletal Pain; Breathing Therapy; Intervention Development

Outcome Measures

Primary Outcomes (2)

• Treatment Acceptability

  Treatment acceptability and satisfaction of the breathwork intervention will be measured using several face-valid items rated on a 10-point scale (1-10) where higher scores represent greater treatment acceptability and satisfaction.

  Day 1

• Change in Pain Intensity and Interference

  The Pain, Enjoyment, and General Activities (PEG-3) scale will be used to assess pain intensity and pain interference over the past week on average.

  Change from Baseline to 1-week follow-up, 1-month follow-up

Secondary Outcomes (15)

• Patient's Global Impressions of Change

  1-week follow-up, 1-month follow-up

• Change in Pain Catastrophizing

  Change from Baseline to 1-week follow-up, 1-month follow-up

• Acute Treatment Effects

  Day 1

• Change in Pain Self-Efficacy

  Change from Baseline to 1-month follow-up

• Change in Sleep Disturbances

  Change from Baseline to 1-week follow-up, 1-month follow-up

Study Arms (1)

Integrative Breathwork Intervention

EXPERIMENTAL

The breathwork intervention will be delivered in groups of 2-5 participants with chronic musculoskeletal pain. A conscious connected breathing technique will be engaged in for 45-60 minutes.

Behavioral: Integrative Breathwork Intervention

Interventions

Integrative Breathwork Intervention BEHAVIORAL

The breathwork intervention involves a sustained conscious connected breathing pattern where there is no pause between inhale and exhale. During the breathing, a participant is guided to pay attention to the strongest sensation from moment-to-moment (e.g., mindfulness of somatic sensations) and relax unnecessary effort or tension. Participants lay supine throughout the 60 minute session. The session ends with spontaneous, relaxed breathing and an opportunity to briefly share one's experience.

Integrative Breathwork Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18-70 years of age.
• Chronic musculoskeletal pain lasting for at least 3 months as a symptom of axial pain (e.g., back, neck) or limb pain (e.g., shoulder, knee, hip, wrist).
• Average pain intensity of ≥ 4/10 for the past month.
• Access to internet with a valid email address
• Able to lay down and stay relatively still for one hour.

You may not qualify if:

• Any suspicion of a medical (orthopedic, rheumatic or neurological) disease, that can fully explain the current level of severity of pain.
• Chronic pain possibly due to specific conditions (e.g., cancer, infection).
• Ongoing legal action or disability claim related to chronic pain.
• Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy, history of seizures) or moderate or severe symptoms from a previous brain injury, including stroke and traumatic brain injury.
• Respiratory disorder (e.g., chronic obstructive pulmonary disease) or moderate to severe asthma within the past 12 months.
• Activity limiting heart disease including cardiovascular or peripheral arterial disease.
• Uncontrolled hypertension (i.e. SBP/DBP of \> 160/95) or orthostatic hypotension (e.g., issues with fainting).
• Serious acute physical injuries or major surgery within the past 6 months.
• Serious psychiatric disorder (e.g., schizophrenia, panic disorder) or mental health issues requiring hospitalization within the past 12 months or currently on antipsychotic medications.
• History of hospitalization or treatment of substance use disorder within the past 12 months.
• Currently undergoing curative or palliative chemotherapy or radiation.
• Pregnant.
• Glaucoma or detached retina.
• Current participation or participation in the past 2 months of an interventional research study.
• Cognitive impairment or factors that would preclude comprehension of material and/or full participation in the study.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Clinical Research Center

Gainesville, Florida, 32603, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will conduct multiple single-arm iterations testing and refining the group breathwork intervention prior to conducting a pilot randomized controlled trial comparing the refined version of the intervention to a waitlist control group.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 18, 2025
• Study Start: June 18, 2025
• Primary Completion: March 18, 2026
• Study Completion: March 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)