Integrative Breathwork Intervention for Chronic Pain
CompletedPhase 1, Phase 2NCT06546956
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The proposed research is to develop and refine a multicomponent breathwork intervention, Guided Respiration Mindfulness Therapy, and to iteratively evaluate its feasibility, acceptability, and plausibility for clinically significant effects in people with chronic low back pain. This integrative breathwork intervention involves a 60-minute breathing session where the focus is to maintain a conscious connected breathing pattern (no pause between inhale and exhale), apply mindful acceptance to somatic sensations, and relax any physical tension. Each breathwork session will be delivered 1-on-1 in person by a trained facilitator. The treatment consists of 8 breathwork sessions, once per week for 8 weeks.
Study details
- Official title
- Developing and Testing a Multicomponent Breathwork Intervention for Adults With Chronic Pain
- Conditions
- Interventions
- Behavioral: Integrative Breathwork Intervention
- Sponsor
- University of Florida
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2024-10-24
- Primary completion
- 2025-12-10
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Men and women 18-70 years of age. * Chronic primary low back pain that has persisted for at least 3 months and on most days for the past 6 months. * Average pain intensity of ≥ 4/10 for the past month. * Fluent in English. * Access to internet with a valid email address. * Able to lay down and stay relatively still for one hour. Exclusion Criteria: * Leg pain, or any other chronic pain, that is greater than low back pain. * Back pain possibly due to specific conditions (e.g., cancer, infection). * Ongoing legal action or disability claim related to low back pain. * Neurological symptoms associated with low back pain, including loss of control or incontinence of bowel or bladder. * Systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia). * 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). * Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy, history of seizures) or evidence of previous brain injury, including stroke and traumatic brain injury. * Serious acute physical injuries or any surgery within the past 6 months. * Serious psychiatric disorder (e.g., schizophrenia) or mental health issues requiring hospitalization within the past 12 months or currently on anti-psychotic medications. * History of hospitalization or treatment of substance use disorder within the past 12 months. * Currently undergoing curative or palliative chemotherapy or radiation. Pregnant or plan to become pregnant during the study period. * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06546956