Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention

Study Overview
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Brief Summary
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This is a single-site, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a nurse-led, very brief, preoperative mindfulness-based intervention for hip and knee replacement patients will be investigated relative to an audio-recorded very brief, preoperative mindfulness-based intervention delivered during the standard nurse consult and a nurse-led preoperative pain psychoeducation intervention during the standard nurse consult.

Official Title
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Comparing the Effects of an Audio-Recorded Brief Mindfulness-Based Intervention With a Nurse-Led Brief Mindfulness-Based Intervention for Preoperative Knee and Hip Replacement Patients

Conditions
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Pain, Osteoarthritis, Knee, Osteoarthritis, Hip

Intervention / Treatment
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* Behavioral: Standard Pain Management
* Behavioral: Audio-Recorded Mindfulness-Based Intervention
* Behavioral: Nurse-Led Mindfulness-Based Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Age ≥18, 2) Scheduled to undergo unilateral total knee or hip arthroplasty Exclusion Criteria: 1) Cognitive impairment preventing completion of study procedures. 2) Current cancer diagnosis, 3) Contralateral knee or hip replaced in the previous 3 months, 4) Intent to have contralateral knee or hip replaced or other, additional surgical procedure during the study period, 5) Intent to add new pain treatments during the study period (except for what is part of the study), 6) Other unstable illness judged by medical staff to interfere with study treatment.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Standard Pain Psychoeducation<br> | Behavioral: Standard Pain Management<br>* Nurses will provide psychoeducation about pain along with common pain coping strategies, such as rest, ice, and elevation, for use any time they experience intense pain or take pain medication before and after surgery.<br>|
| Active Comparator: Audio-Recorded Mindfulness-Based Intervention<br> | Behavioral: Audio-Recorded Mindfulness-Based Intervention<br>* Nurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then have them listen to a very brief (1 minute 30 second) guided mindfulness practice validated in our prior research to encourage focused attention on breath and body sensations and open monitoring and acceptance of discursive thoughts, negative emotions, and pain. Finally, patients will be given an audio recording of the mindful pain management technique for use any time.<br>|
| Experimental: Nurse-Led Mindfulness-Based Intervention<br> | Behavioral: Nurse-Led Mindfulness-Based Intervention<br>* Nurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then guide them through a very brief (1 minute 30 second) mindfulness practice validated in our prior research to encourage focused attention on breath and body sensations and open monitoring and acceptance of discursive thoughts, negative emotions, and pain. Finally, patients will be given an audio recording of the mindful pain management technique for use any time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | Baseline and after the 10 minute preoperative nurse visit | 

Secondary Outcome Measures

| Outcome Measure | 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. | Baseline and after the 10 minute preoperative nurse visit | 
| Change in Pain Medication Desire Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication. | Baseline and after the 10 minute preoperative nurse visit |