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This project a single-site 3-arm parallel group randomized clinical trial conducted at a tertiary level 1 trauma center among patients undergoing operative fixation of a lower extremity fracture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mind wandering | Placebo Comparator |
| |
| Preoperative Mindfulness | Active Comparator | Participants will only listen to the guided meditation practice before surgery. |
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| Preoperative and Postoperative Mindfulness | Active Comparator | Participant will listen to the guided meditation practice before surgery and during their hospital stay after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative mindfulness | Behavioral | A seven-minute, audio-guided, mindfulness meditation practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Preoperative Anxiety | Single item assessing pain unpleasantness ("How nervous, anxious, or on edge do you feel?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater anxiety. | Immediately before to after the 7-minute preoperative intervention |
| Change in Postoperative, In-patient Pain Unpleasantness | Single item assessing pain unpleasantness ("How unpleasant is your pain?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain unpleasantness. | Immediately before to after the 7-minute postoperative intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Preoperative Pain Intensity | Single item assessing pain intensity ("How much pain do you have?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain intensity. | Immediately before to after the 7-minute preoperative intervention |
| Change in Postoperative, In-patient Pain Intensity |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0 | The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores reflect better physical functioning. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| Postoperative mindfulness | Behavioral | A seven-minute, audio-guided, mindfulness meditation practice. |
|
| Mind wandering | Behavioral | A timed, seven-minute mind wandering period during which participants are instructed: "For the next 7 minutes, allow your mind to wander." |
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Single item assessing pain intensity ("How much pain do you have?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain intensity. |
| Immediately before to after the 7-minute postoperative intervention |
| Change in Preoperative Pain Unpleasantness | Single item assessing pain unpleasantness ("How unpleasant is your pain?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain unpleasantness. | Immediately before to after the 7-minute preoperative intervention |
| Change in Postoperative, In-patient Anxiety | Single item assessing pain unpleasantness ("How nervous, anxious, or on edge do you feel?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater anxiety. | Immediately before to after the 7-minute postoperative intervention |
| Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively |
| Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Bank v1.1 | The PROMIS pain interference computer assisted test draws from a bank of 40 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores reflect greater pain interference. | Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively |
| Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Bank v1.0 | The PROMIS anxiety computer assisted test draws from a bank of 29 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores reflect greater anxiety. | Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively |
| Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Depression Bank v1.0 | The PROMIS depression computer assisted test draws from a bank of 28 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores reflect greater depression. | Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively |