Anxiety, Pain
Conditions
Brief summary
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.
Interventions
BEHAVIORALPreoperative mindfulness
A seven-minute, audio-guided, mindfulness meditation practice.
BEHAVIORALPostoperative mindfulness
A seven-minute, audio-guided, mindfulness meditation practice.
BEHAVIORALMind wandering
A timed, seven-minute mind wandering period during which participants are instructed: For the next 7 minutes, allow your mind to wander.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age at presentation between 18 and 65 years * Acute lower extremity fracture to be operatively managed * Glasgow Coma Scale of 15 * English speaking * Willingness to participate in study
Exclusion criteria
* Cognitive impairment * Pregnant or lactating woman * Current incarceration * Planned secondary procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Preoperative Anxiety | Immediately before to after the 7-minute preoperative intervention | 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. |
| Change in Postoperative, In-patient Pain Unpleasantness | Immediately before to after the 7-minute postoperative intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Postoperative, In-patient Pain Intensity | Immediately before to after the 7-minute postoperative intervention | 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. |
| Change in Preoperative Pain Intensity | Immediately before to after the 7-minute preoperative intervention | 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. |
| Change in Preoperative Pain Unpleasantness | Immediately before to after the 7-minute preoperative intervention | 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. |
| Change in Postoperative, In-patient Anxiety | Immediately before to after the 7-minute postoperative intervention | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Bank v1.0 | Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively | 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. |
| Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Depression Bank v1.0 | Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively | 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. |
| Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Bank v1.1 | Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively | 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. |
| Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0 | Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively | 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. |
Countries
United States
Outcome results
None listed