Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

Study Overview
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Brief Summary
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This was a single site, three-arm, parallel group randomized clinical trial that compared the effect of three preoperative psychosocial interventions on knee and hip replacement patients' preoperative pain intensity and postoperative pain intensity, pain unpleasantness, and opioid use.

Official Title
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Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

Conditions
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Pain, Pain, Acute, Pain, Joint

Intervention / Treatment
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* Behavioral: Mindfulness of Breath
* Behavioral: Mindfulness of Pain
* Behavioral: Cognitive-Behaviorally Based Pain Psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking males or females. 18 years old or older Patients within the University of Utah Hospital system Patients attending Joint Academy to prepare for either hip or knee replacement surgery Exclusion Criteria: Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness of Breath<br> | Behavioral: Mindfulness of Breath<br>* Mindfulness of Breath consisted of instruction in focused attention on the breath and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.<br>|
| Experimental: Mindfulness of Pain<br> | Behavioral: Mindfulness of Pain<br>* Mindfulness of Pain consisted of instruction in how to (1) zoom in to deconstruct pain into its constituent physical sensations and precisely map each sensation's spatial location, (2) use mindful breathing to zoom out and broaden the field of attention to include previously neglected sensory elements (i.e., spaces within the body that were absent of sensation and pleasant sensations), and (3) shift attention from unpleasant sensations to neutral/pleasant sensations or experiences.<br>|
| Active Comparator: Cognitive-Behaviorally Based Pain Psychoeducation<br> | Behavioral: Cognitive-Behaviorally Based Pain Psychoeducation<br>* Cognitive-Behaviorally Based Pain Psychoeducation consisted of psychoeducation about the link between thoughts, emotions, and behavior and provided instruction in the use logic to dispute maladaptive thoughts about pain that might otherwise exacerbate pain and distress.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Preoperative Pain Intensity | Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable. | Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes) | 
| Change in Postoperative Pain Intensity | Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable. | Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Postoperative Pain Unpleasantness | Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most unpleasant pain imaginable. | Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days. | 
| Change in Postoperative Opioid Use | Single-item, dichotomously scored (no vs. yes): Did you take opioid medications in the last 24 hours? | Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days. |