Breathwork for Chronic Musculoskeletal Pain
NCT Number: NCT06455839
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Chronic Pain|Pain, Chronic|Musculoskeletal Pain
Interventions: BEHAVIORAL: Guided Resipiration Mindfulness Therapy (GRMT)
Sponsor: Florida State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-29
Completion Date: 2025-11-01
Locations: Brian Science and Symptom Management Center, Tallahassee, Florida, 32310, United States

Summary:
This project is a single-site, single-arm, clinical feasibility trial examining the impact of a single-session, 2-hour Guided Respiration Mindfulness Therapy training for chronic musculoskeletal pain.

Primary Outcome Measures: Number of Participants with Chronic Pain Recruited, Examine recruitment rates during the 1 week of recruitment., 1 week|Intervention Adherence, Examine the percentage of participants completing their 2-hour intervention session., 2 Hours|Treatment Acceptability, Treatment acceptability will be assessed with a 12-item adaptation of the Treatment Framework of Acceptability questionnaire. Scores range from 5 to 45. Higher scores reflect greater acceptability., Completed immediately after the 2-hour GRMT training
Secondary Outcome Measures: Global Impression of Change, Treatment related improvement will be assessed with the Patient Global Impression of Change scale. Scores range from 0 to 7, with higher scores reflecting greater treatment related improvement., Completed at 2- and 6-week follow-ups
Other Outcome Measures: Acute Pain Unpleasantness, Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness., Will be completed immediately before and after the 2-hour intervention session|Acute Pain Intensity, Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity., Will be completed immediately before and after the 2-hour intervention session|Daily Pain Intensity, Change in daily pain intensity from from the first post-intervention day through the 6-week follow-up will be assessed with the pain intensity item from the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain intensity., Daily for 6 weeks|Daily Pain Interference, Change in daily pain interference from from the first post-intervention day through the 6-week follow-up will be assessed with the two pain interference items from the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain interference., Daily for 6 weeks|Chronic Pain, Change in chronic pain from baseline through 6-week follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater chronic pain., Baseline, 2 weeks post-treatment, 6 week post-treatment|Sleep, Change in sleep from baseline through 6-week follow-up will be assessed with the PROMIS Sleep Disturbance Short Form. Scores range from 6 to 30, with higher scores reflecting worse sleep., Baseline, 2 weeks post-treatment, 6 week post-treatment|Pain Catastrophizing, Change in pain catastrophizing from baseline through 6-week follow-up will be assessed with the Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores reflecting greater pain catastrophizing., Baseline, 2 weeks post-treatment, 6 week post-treatment|Depression, Change in depression from baseline through 6-week follow-up will be assessed with the Patient Health Questionnaire-2. Scores range from 0 to 6, with higher scores reflecting greater depression., Baseline, 2 weeks post-treatment, 6 week post-treatment|Anxiety, Change in anxiety from baseline through 6-week follow-up will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety., Baseline, 2 weeks post-treatment, 6 week post-treatment|Prescription Pain Medication Use, Change in prescription pain medication misuse from baseline through 6-week follow-up will be assessed with the PROMIS Prescription Pain Medication Misuse Short Form. Scores range from 7 to 35, with higher scores reflecting greater medication misuse., Baseline, 2 weeks post-treatment, 6 week post-treatment|Mindful Pain Management, Change in the use of mindfulness for pain management from baseline through 6-week follow-up will be assessed with the Mindful Reappraisal of Pain Scale. Scores range from 0 to 54, with higher scores reflecting greater mindful pain management., Baseline, 2 weeks post-treatment, 6 week post-treatment|Self-Transcendent Experiences, Change in the the frequency of self-transcendent experiences from baseline through 6-week follow-up will be assessed with the Nondual Awareness Dimensional Assessment. Scores range from 0 to 5, with higher scores reflecting more frequent self-transcendent experiences., Baseline, 2 weeks post-treatment, 6 week post-treatment