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This project is a single-site, single-arm, clinical feasibility trial examining the impact of a single-session, 2-hour connected consciousness breathing with breath retention (CCBR) training for chronic musculoskeletal pain.
CCBR is a breathwork style that involves breathing with no pause between inhalation and exhalation (also known as circular breathing). This breathing pattern is maintained for a given period of time, ranging from 5 minutes to over 2 hours. In the proposed project, the CCBR training will begin with a 15-minute introduction to CCBR, followed by an hour and 15 minutes of therapist-guided CCBR practice. The final 30 minutes will be used to discuss participant experiences during the CCBR practice. CCBR training sessions will occur in-person and in a small group format (5 participants each).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided Respiration Mindfulness Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Resipiration Mindfulness Therapy (GRMT) | Behavioral | GRMT provides training in respiratory regulation, mindfulness and relaxation. The GRMT training will begin with a 15-minute introduction to the treatment model, followed by an hour of therapist-guided respiration (i.e., continuous rhythmic expansion of the chest, and relaxed exhalation involving release of all respiratory and peripheral musculature). The final 45 minutes will be used to discuss participant experiences during the GRMT training. GRMT training sessions will occur in-person and in a small group format (<5 participants each). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brian Science and Symptom Management Center | Tallahassee | Florida | 32310 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
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| 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 |
| D009140 | Musculoskeletal Diseases |