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| ID | Type | Description | Link |
|---|---|---|---|
| OCR39823 | Other Identifier | UF OnCore | |
| IRB202002612 | Other Identifier | UF IRB-01 |
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The purpose of this research study is to see if breathing and attention training (BAT) treatments improve pain symptoms and well-being in people who have chronic low back pain (cLBP). For this breathing intervention, you will be randomly assigned to either standard or focused BAT. The standard BAT includes instructions on deep breathing and relaxation. The focused BAT is similar to the standard BAT in most ways but includes extra instructions to help you focus and alter your breathing patterns.
The primary objective of the proposed pilot randomized controlled trial (RCT) is to examine the safety, feasibility, and acceptability of a 5-day breathing and attention training (BAT) in a sample of 30 adults with cLBP. The secondary objective is to explore preliminary clinical efficacy and potential mechanisms of the breathing interventions (focused-BAT and standard-BAT), by examining changes in clinical pain outcomes and potential pain-related psychological, physiological, and behavioral mediating variables. Both interventions will be delivered via an audio recording in order to standardize the interventions across participants and to enhance treatment fidelity. Results from this study will inform the successful design and implementation of a larger RCT and provide preliminary evidence regarding the potential efficacy of this breathing intervention for people with cLBP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Breathing and Attention Training | Active Comparator | The standard breathing and attention training (BAT) includes guided instructions on deep breathing and relaxation. Participants will practice standard BAT once a day for 15 minutes for 5 days in a row. |
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| Focused Breathing and Attention Training | Experimental | The focused BAT is similar to the standard BAT in most ways but includes extra instructions to help focus and alter breathing patterns. Participants will practice focused BAT once a day for 15 minutes for 5 days in a row. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathing and Attention Training | Behavioral | A guided audio recording will instruct participants to alter their breathing and pay attention in specific ways. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Satisfaction Questionnaire | Treatment acceptability and participant satisfaction will be measured with several items rated on a 10-point scale where higher scores represent greater treatment acceptability and satisfaction. | 3-months |
| Incidence of Adverse Events | Number of serious adverse events | Through study completion, up to 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity | Numerical rating scale (1- "No pain", 10- "Worst pain imaginable") of current pain intensity measured before and after each intervention session. | Baseline, Day 1, Day 2, Day 3, Day 4, Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36694217 | Derived | Pratscher SD, Sibille KT, Fillingim RB. Conscious connected breathing with breath retention intervention in adults with chronic low back pain: protocol for a randomized controlled pilot study. Pilot Feasibility Stud. 2023 Jan 24;9(1):15. doi: 10.1186/s40814-023-01247-9. |
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IPD may be shared upon request by other researchers.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D017116 | Low Back Pain |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012119 | Respiration |
| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| D001416 | Back Pain |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |