Psychosocial Support for Acute Hospital 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 social workers to patients reporting uncontrolled pain during a hospital stay. This study will examine the differential effects of brief mindfulness training, therapeutic suggestion, and psychoeducation for patients reporting uncontrolled pain.

Official Title
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Psychosocial Support for Acute Hospital 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 or older within the University of Utah Hospital system reporting intolerable pain or inadequate pain control on the Clinically Aligned Pain Assessment Tool (CAPA; Donaldson & Chapman, 2013). 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: Single


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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity (numeric rating scale) | 0-10 scale | Immediately prior to and following intervention | 
| Pain unpleasantness (numeric rating scale) | 0-10 scale | Immediately prior to and following intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of opioid analgesics | The total amount of opioid analgesic use will be computed during the 24 hours prior to and following intervention. Opioid dose will be standardized and calculated using conventional morphine daily equivalent equianalgesic conversion tables. | 24 hours prior to and following intervention | 
| Anxiety (numeric rating scale) | 0-10 scale | Immediately prior to and following intervention | 
| Relaxation (numeric rating scale) | 0-10 scale | Immediately prior to and following intervention | 
| Desire for opioids (numeric rating scale) | 0-10 scale | Immediately prior to and following intervention | 
| Positive body sensations (numeric rating scale) | 0-10 scale | Immediately prior to and following intervention | 
| Use of non-opioid analgesics (NSAID) | The total amount of opioid analgesic use will be computed during the 24 hours prior to and following intervention. NSAID dose will be standardized and calculated using conventional NSAID equianalgesic conversion tables. | Within 24 hours prior to and following intervention |