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RECRUITING

NCT06546956

PHASE1/PHASE2

Integrative Breathwork Intervention for Chronic Pain

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

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.

Official title: Developing and Testing a Multicomponent Breathwork Intervention for Adults With Chronic Pain

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-10-24

Completion Date

2027-05-22

Last Updated

2025-11-06

Healthy Volunteers

Conditions

Chronic Low-back Pain

Interventions

BEHAVIORAL

Integrative Breathwork Intervention

GRMT has three core components: respiratory regulation (i.e., sustained conscious connected breathing pattern into the upper chest where there is no pause between inhale and exhale), mindfulness of somatic sensations while breathing (i.e., interoceptive awareness with acceptance), and relaxation of physical tension. These components are the primary focus in every breathwork session. The intervention is delivered 1-on-1 in-person with a trained facilitator. Participants lay supine throughout the 60 minute session. The facilitator observes the participant's breathing pattern and guides the participant to apply the three core components. Each session ends with spontaneous, relaxed breathing and an opportunity to briefly share what happened during the session.

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.

Locations (1)

University of Florida

Gainesville, Florida, United States