Chronic Pain, Musculoskeletal Pain, Pain, Pain, Chronic
Conditions
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALGuided Resipiration Mindfulness Therapy (GRMT)
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).
Sponsors
Florida State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* having received a professional diagnosis of clinical levels of chronic pain * being able to not commit to another (new) treatment during the course of the study * understanding English instructions fluently * Being 18 and above
Exclusion criteria
* having learned to practice breathwork any time in the past * being unable to perform most basic tasks due to pain or pain treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Chronic Pain Recruited | 1 week | Examine recruitment rates during the 1 week of recruitment. |
| Intervention Adherence | 2 Hours | Examine the percentage of participants completing their 2-hour intervention session. |
| Treatment Acceptability | Completed immediately after the 2-hour GRMT training | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Impression of Change | Completed at 2- and 6-week follow-ups | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chronic Pain | Baseline, 2 weeks post-treatment, 6 week post-treatment | 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. |
| Sleep | Baseline, 2 weeks post-treatment, 6 week post-treatment | 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. |
| Pain Catastrophizing | Baseline, 2 weeks post-treatment, 6 week post-treatment | 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. |
| Depression | Baseline, 2 weeks post-treatment, 6 week post-treatment | 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. |
| Acute Pain Unpleasantness | Will be completed immediately before and after the 2-hour intervention session | 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. |
| Prescription Pain Medication Use | Baseline, 2 weeks post-treatment, 6 week post-treatment | 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. |
| Mindful Pain Management | Baseline, 2 weeks post-treatment, 6 week post-treatment | 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. |
| Self-Transcendent Experiences | Baseline, 2 weeks post-treatment, 6 week post-treatment | 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. |
| Anxiety | Baseline, 2 weeks post-treatment, 6 week post-treatment | 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. |
| Acute Pain Intensity | Will be completed immediately before and after the 2-hour intervention session | 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. |
| Daily Pain Intensity | Daily for 6 weeks | 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 Pain Interference | Daily for 6 weeks | 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. |
Countries
United States
Outcome results
None listed