Psychosocial Support for Pre-operative Pain and Distress

Study Overview
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Brief Summary
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The purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professionals to pre-operative joint replacement patients. This study will examine the differential effects of brief mindfulness training, hypnostic suggestion, and cognitive behavioral pain psychoeducation for pre-operative patients, with a supplemental nonrandomized usual care comparison group.

Official Title
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Psychosocial Support for Pre-operative Pain and Distress

Conditions
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Acute Pain

Intervention / Treatment
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* Behavioral: Mindfulness
* Behavioral: Suggestion
* Behavioral: 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 the Joint Replacement 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness<br>15 minute mindfulness session | Behavioral: Mindfulness<br>* The 15 minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experience in a non-judgmental fashion.<br>|
| Experimental: Suggestion<br>15 minute therapeutic suggestion session | Behavioral: Suggestion<br>* The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.<br>|
| Active Comparator: Psychoeducation<br>15 minute psychoeducation session | Behavioral: Psychoeducation<br>* The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.<br>|
| No Intervention: Usual Care<br>The usual care comparison group was comprised of patients who underwent total joint arthroplasty of the hip or knee at the same academic medical center during the study period but who did not attend Joint Academy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediately prior to and following intervention | 
| 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. | Immediately prior to and following intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediately prior to and following intervention | 
| Anxiety Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing very anxious. | Immediately prior to and following intervention | 
| 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. A high score better physical functioning. | During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment. | 
| Nondual Awareness Dimensional Assessment - State | Three Likert scale item ranging from 0-30, with 0 indicating no nondual awareness and 10 representing complete nondual awareness. Items can also be used individually. Item one is a single Likert scale item ranging from 0-10, with 0 indicating no relational unity and 10 representing complete relational unity. Item two is a single Likert scale item ranging from 0-10, with 0 indicating no annihilational unity and 10 representing complete annihilational unity. Item three is a single Likert scale item ranging from 0-10, with 0 indicating no bliss and 10 representing complete bliss. | Immediately prior to and following intervention | 
| Sensation Manikin Body Sensation Report | The ratio of pleasant to unpleasant bodily sensations reported on a sensation manikin. Ratio scores below 1 indicate unpleasant sensations predominate in the body and ratio scores above 1 indicate pleasant scores predominate. | Immediately prior to and following intervention |