An interventional study of Integrative Breathwork Intervention in Chronic Pain, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
Multiple single-arm iterations of a group breathwork intervention will be conducted to refine and optimize the intervention and protocol. Upon completion of each iteration, quantitative and qualitative data will be gathered to identify possible modifications before proceeding with the next iteration. After achieving a satisfactory intervention, we will conduct a pilot randomized controlled trial compared to a waitlist control group. This work will provide initial evidence on the feasibility, acceptability, and plausibility of clinically significant effects of this type of multicomponent breathwork intervention for adults with chronic low back pain.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion Criteria:
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
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.
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.
Time frame: 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.
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Patient's Global Impressions of Change
The Patient's Global Impression of Change single-item measure asks participants to describe any changes in activity limitations, symptoms, emotions, and overall quality of life, related to their pain since the beginning of the treatment. (Higher scores represent greater impressions of benefit from the intervention.)
Time frame: 1-week follow-up, 1-month follow-up
Change in Pain Catastrophizing
Assessed using the 13-item Pain Catastrophizing Scale. (Scores range from 0-52; higher scores represent higher levels of pain catastrophizing).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Acute Treatment Effects
Assessed using face-valid items related to feelings and emotions immediately before and after the intervention session. Scores will be calculated by subtracting post-intervention to pre-intervention where higher scores represent greater acute subjective effects.
Time frame: Day 1
Change in Pain Self-Efficacy
Assessed using the 10-item Pain Self-Efficacy Scale. (0-6; higher scores represent higher levels of pain self-efficacy).
Time frame: Change from Baseline to 1-month follow-up
Change in Sleep Disturbances
Assessed using the PROMIS-Sleep Disturbance 8b scale. (1-5; higher scores represent higher levels of sleep disturbance).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Sleep Related Impairment
Assessed using the PROMIS-Sleep Related Impairment 8a scale. (1-5; higher scores represent higher levels of sleep related impairment).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Fatigue
Assessed using the PROMIS Fatigue-8a scale. (1-5; higher scores represent higher levels of fatigue over the past week).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Whole Person Health
Assessed using the Whole Person Health Index. (1-5; lower scores represent better levels of self-assessed health ).
Time frame: Change from Baseline to 1-month follow-up
Change in Stress
Assessed using the 4-item Perceived Stress Scale. (0-4; higher scores represent higher levels of subjective stress over the past month).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Anxiety
Assessed using the Generalized Anxiety Disorder-2 Questionnaire. (0-3; higher scores represent higher levels of anxiety over the past 2 weeks).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Depression
Assessed using the Patient Health Questionnaire-2.(0-3; higher scores represent higher levels of depression over the past 2 weeks).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Fear Avoidance Beliefs
Assessed using the 5-item Fear-Avoidance Beliefs Questionnaire-physical activity subscale. (0-6; higher scores represent higher levels of physical activity-related fear-avoidance beliefs).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Interoception
Assessed using the Multidimensional Assessment of Interoceptive Awareness-2. (0-5; higher scores represent higher levels of interoception).
Time frame: Change from Baseline to 1-month follow-up
Change in Multisensory Sensitivity
Assessed using the Multisensory Amplification Scale will be used to assess symptoms of central nervous system hypersensitivity, or central sensitization. (1-5; higher scores represent higher levels of sensory sensitivity).
Time frame: Change from Baseline to 1-month follow-up
Psychological Insight
Assessed using the Psychological Insight Questionnaire where higher scores represent greater levels of psychological insight arising from the breathwork intervention.
Time frame: 1-month follow-up
Plan to share: Undecided
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University of Florida