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This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded cyclical sighing intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Coping Information | Active Comparator |
| |
| Cyclical Sighing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Coping Information | Behavioral | A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Unpleasantness Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable. | immediately after the 4-minute audio recording |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable. | Immediately after the 4-minute audio recording |
| Change in Anxiety Numeric Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tallahassee Orthopedic Clinic (TOC) | Tallahassee | Florida | 32308 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39904867 | Derived | Hanley AW, Davis A, Worts P, Pratscher S. Cyclic sighing in the clinic waiting room may decrease pain: results from a pilot randomized controlled trial. J Behav Med. 2025 Apr;48(2):385-393. doi: 10.1007/s10865-024-00548-5. Epub 2025 Feb 4. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Cyclical Sighing | Behavioral | A 4-minute audio recording consisting of a 1-minute introduction to cyclical sighing followed by a 3-minute cyclical sighing practice. |
|
Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing intense anxiety. |
| Immediately after the 4-minute audio recording |
| Change in Depression Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no depression and 10 representing intense depression. | Immediately after the 4-minute audio recording |