Mindfulness Intervention in Orthopedic Trauma Patients

Study Overview
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Brief Summary
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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.

Official Title
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Pilot RCT of Mindfulness Intervention in Orthopedic Trauma Patients

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Behavioral: Preoperative mindfulness
* Behavioral: Postoperative mindfulness
* Behavioral: Mind wandering


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Mind wandering<br> | Behavioral: Mind wandering<br>* A timed, seven-minute mind wandering period during which participants are instructed: For the next 7 minutes, allow your mind to wander.<br>|
| Active Comparator: Preoperative Mindfulness<br>Participants will only listen to the guided meditation practice before surgery. | Behavioral: Preoperative mindfulness<br>* A seven-minute, audio-guided, mindfulness meditation practice.<br>Behavioral: Mind wandering<br>* A timed, seven-minute mind wandering period during which participants are instructed: For the next 7 minutes, allow your mind to wander.<br>|
| Active Comparator: Preoperative and Postoperative Mindfulness<br>Participant will listen to the guided meditation practice before surgery and during their hospital stay after surgery. | Behavioral: Preoperative mindfulness<br>* A seven-minute, audio-guided, mindfulness meditation practice.<br>Behavioral: Postoperative mindfulness<br>* A seven-minute, audio-guided, mindfulness meditation practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |