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Completed

NCT Number: NCT06977984

Group Integrative Breathwork for Chronic Pain

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Clinical Research Center

Gainesville, Florida, 32603, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Any significant comorbidities or other reasons that, in the opinion of the investigators, could interfere with the study or lead to deleterious effects for the participant.

Treatment and study plan

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.

Primary outcomes

  1. Treatment Acceptability

    Time frame: Day 1

    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.

  2. Change in Pain Intensity and Interference

    Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up

    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.

Secondary outcomes

  1. Patient's Global Impressions of Change

    Time frame: 1-week follow-up, 1-month follow-up

    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.)

  2. Change in Pain Catastrophizing

    Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up

    Assessed using the 13-item Pain Catastrophizing Scale. (Scores range from 0-52; higher scores represent higher levels of pain catastrophizing).

  3. Acute Treatment Effects

    Time frame: Day 1

    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.

  4. Change in Pain Self-Efficacy

    Time frame: Change from Baseline to 1-month follow-up

    Assessed using the 10-item Pain Self-Efficacy Scale. (0-6; higher scores represent higher levels of pain self-efficacy).

  5. Change in Sleep Disturbances

    Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up

    Assessed using the PROMIS-Sleep Disturbance 8b scale. (1-5; higher scores represent higher levels of sleep disturbance).

  6. Change in Sleep Related Impairment

    Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up

    Assessed using the PROMIS-Sleep Related Impairment 8a scale. (1-5; higher scores represent higher levels of sleep related impairment).

  7. Change in Fatigue

    Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up

    Assessed using the PROMIS Fatigue-8a scale. (1-5; higher scores represent higher levels of fatigue over the past week).

  8. Change in Whole Person Health

    Time frame: Change from Baseline to 1-month follow-up

    Assessed using the Whole Person Health Index. (1-5; lower scores represent better levels of self-assessed health ).

  9. Change in Stress

    Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up

    Assessed using the 4-item Perceived Stress Scale. (0-4; higher scores represent higher levels of subjective stress over the past month).

  10. Change in Anxiety

    Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up

    Assessed using the Generalized Anxiety Disorder-2 Questionnaire. (0-3; higher scores represent higher levels of anxiety over the past 2 weeks).

  11. Change in Depression

    Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up

    Assessed using the Patient Health Questionnaire-2.(0-3; higher scores represent higher levels of depression over the past 2 weeks).

  12. Change in Fear Avoidance Beliefs

    Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up

    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).

  13. Change in Interoception

    Time frame: Change from Baseline to 1-month follow-up

    Assessed using the Multidimensional Assessment of Interoceptive Awareness-2. (0-5; higher scores represent higher levels of interoception).

  14. Change in Multisensory Sensitivity

    Time frame: Change from Baseline to 1-month follow-up

    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).

  15. Psychological Insight

    Time frame: 1-month follow-up

    Assessed using the Psychological Insight Questionnaire where higher scores represent greater levels of psychological insight arising from the breathwork intervention.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Group Breathwork Intervention for Chronic Pain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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