- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02729350
The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT
The Feasibility of the PAINReportIt Guided Relaxation Intervention for Pain and Stress in Adult Inpatients With Sickle Cell Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Guided Relaxation video clip
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.
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This intervention is a 12-minute guided relaxation intervention for reducing pain and stress in adult inpatients with sickle cell disease.
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Other: Sickle cell experience discussion
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.
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This intervention is a 12-minute sickle cell disease experience discussion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Current Pain
Time Frame: Immediate (Day 1 baseline) and Day 2-5
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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.
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Immediate (Day 1 baseline) and Day 2-5
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Average pain intensity
Time Frame: Short-term (Day 5)
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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.
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Short-term (Day 5)
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Composite pain index
Time Frame: Short-term (Day 5)
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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.
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Short-term (Day 5)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Current stress
Time Frame: Immediate (Day 1 baseline) and Days 2-5
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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.
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Immediate (Day 1 baseline) and Days 2-5
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Average stress intensity
Time Frame: Short-term (Day 5)
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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.
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Short-term (Day 5)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiologic markers of relaxation (pulse, respiration, finger temperature)
Time Frame: Immediate (baseline)
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Physiological markers of relaxation (pulse, respiration, finger temperature) will be measured using a standard vital sign measuring device.
We expect to observe trends for the immediate GR effect in terms of decreases in relaxation indicators (respiration rate, heart rate) and increases in skin temperature.
We will estimate intervention effects using regression analysis.
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Immediate (baseline)
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Level of relaxation
Time Frame: Immediate (Day 1 baseline) and Day 2-5
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Relaxation rating scale.
A 1-item scale that asks patients to report their level of relaxation on a scale of 0 to 10, where 0 is "not at all relaxed" and 10 is "completely relaxed."
We will estimate intervention effects using linear regression.
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Immediate (Day 1 baseline) and Day 2-5
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Perceived stress
Time Frame: Baseline
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Perceived Stress Questionnaire: A 30-item questionnaire that measures perceived stress in the last two weeks.
An overall perceived stress index (PSI) score for each scale is computed by subtracting 30 from the raw score and dividing it by 90, yielding scores that range from 0 to 1. Higher scores indicate greater perceived stress recent.
We will analyze data using linear regression.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Miriam O Ezenwa, PhD, RN, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201500671
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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