The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT

Study Overview
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Brief Summary
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The goal of this research study is to improve the self-management of pain, stress, and cognitive/affective symptoms that may result in adult inpatients with sickle cell disease (SCD) by determining the feasibility of a self-management guided relaxation (GR) stress reduction intervention using a tablet-based mobile device. Currently, opioid analgesics are primarily used to treat SCD pain while self-managed behavioral modalities such as GR, are rarely used, particularly, in inpatient settings. Little is known about the effects or mechanisms of GR on pain, stress, and cognitive/affective symptoms in adults with SCD hospitalized with pain. Emerging evidence from the hypothalamic pituitary adrenal (HPA) axis theory offer insights for understanding the mechanisms. Adding GR as a supplement to analgesic therapies will address the dearth of self-management strategies for controlling pain in SCD. GR is a simple and cost-effective non-drug intervention that could reduce pain and stress in inpatients with SCD. GR is an intervention where inpatients with SCD are directed to listen to and view audio-visual recordings while they visualize themselves being immersed in that scenario.

Detailed Description
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The purpose of this research study is to see if a new computerized stress reduction program, called PAINReportIt Guided Relaxation Intervention, can be used to teach people who have sickle cell disease (SCD) how to track their stress and pain daily and use guided audio-visual relaxation exercises to help them reduce their stress and pain. To obtain preliminary data for a larger trial, 30 adult inpatients with SCD admitted with SCD pain will be recruited. The investigators will stratify patients on worst pain intensity (<=5 and >5) and randomly assign 15 adults to Attention Control (12-min SCD experience discussion on Day 1 and daily stress/pain tracking on Days 2-4) and 15 adults to Experimental (12-min GR video clip on Day 1 and daily stress/pain tracking and GR on Days 2-4) groups. Immediate effects on pain, stress, and relaxation responses after the 12-min session will be examined. Patients will continue the trial for additional 4 days, with self-management on Days 2-4 and posttest on Day 5 while hospitalized to test short-term effects. During Days 2-4, the experimental group will choose and watch any of six video clips (2 min, 5 min, 8 min, 10 min, 15 min, and 20 min lengths) at least once a day; and at stress onset and as often as they need. We will investigate mechanisms by which GR produces its effects in adult inpatients with SCD.

Official Title
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The Feasibility of the PAINReportIt Guided Relaxation Intervention for Pain and Stress in Adult Inpatients With Sickle Cell Disease

Conditions
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Stress, Sickle Cell Disease, Pain

Intervention / Treatment
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* Behavioral: Guided Relaxation video clip
* Behavioral: Sickle Cell Disease Experience Discussion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has SCD diagnosis; Reports pain 3 or greater in the previous 24 hours (0-10 scale) admitted to University of Florida (UF) Health for pain crisis Speaks and reads English 18 years of age or older self-identifies as being of African descent or Hispanic Exclusion Criteria: Legally blind Physically or cognitively unable to complete study measures

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: Guided Relaxation video clip<br>This intervention is a 12-minute guided audio-visual relaxation intervention delivered at the baseline (Day 1) visit to determine the immediate effects of guided relaxation intervention on stress and pain in inpatients with sickle cell disease. The GR intervention also includes six video clips, ranging from 2 to 20 minutes in length to determine the short-term (Day 5) effects of guided relaxation intervention on stress and pain. | Behavioral: Guided Relaxation video clip<br>* This intervention is a 12-minute guided relaxation intervention for reducing pain and stress in adult inpatients with sickle cell disease.<br>|
| Other: Sickle cell experience discussion<br>Attention Control Group: This intervention is a 12-minute sickle cell disease experience discussion. In this computer-based discussion, patients will discuss their experience of having sickle cell disease. The audio-taped questions and onscreen directions were programmed to be self-administered. Subjects' responses will be captured via the microphone so that Data Collectors are not involved in this discussion process, and it is equivalent to the guided relaxation activity. | Behavioral: Sickle Cell Disease Experience Discussion<br>* This intervention is a 12-minute sickle cell disease experience discussion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current Pain | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity scale: A 3-item scale that asks patients to report their pain now, worst, and average on a scale of 1 to 5 where 1 is had no pain and 5 is very severe. We will estimate intervention effects using regression analysis. | Immediate (Day 1 baseline) and Day 2-5 | 
| Average pain intensity | PAINReportIt® Pain intensity scale: A 3-item scale that asks patients to report their current, least, and worst pain intensity today, on a scale of 0 to 10, where 0 is no pain and 10 is pain as bad as it could be. We will average the three scores to create an average pain intensity score. We will estimate intervention effects using linear regression. | Short-term (Day 5) | 
| Composite pain index | PAINReportIt® Composite pain index (CPI): A a multidimensional representation of pain calculated by averaging the individual proportional scores for each of the four pain dimensions: (1) number of pain sites; (2) pain intensity; (3) total pain rating index (from the McGill Pain Questionnaire [MPQ], pain quality); and (4) pain pattern score. The scores for the CPI range from 0 to 100. We will estimate intervention effects using linear regression. | Short-term (Day 5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current stress | Stress intensity scale: A 3-item scale that asks patients to report their current, least, and worst stress intensity today, on a scale of 0 to 10, where 0 is no stress and 10 is stress as bad as it could be. We will estimate intervention effects using linear regression. | Immediate (Day 1 baseline) and Days 2-5 | 
| Average stress intensity | Stress intensity scale: A 3-item scale that asks patients to report their current, least, and worst stress intensity today, on a scale of 0 to 10, where 0 is no stress and 10 is stress as bad as it could be. We will average the three scores to create an average stress intensity score. We will estimate intervention effects using linear regression. | Short-term (Day 5) |