The Feasibility of the PAINReportIt Guided Relaxation Intervention-Outpatient
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|ClinicalTrials.gov Identifier: NCT02729363|
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : January 22, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Stress Pain||Behavioral: Guided Relaxation video clip Behavioral: Sickle Cell Disease Experience Discussion||Not Applicable|
The investigator will recruit adult outpatients with sickle cell disease (SCD) from the University of Florida Health Hematology Clinics and conduct study visits in a research room located at the College of nursing.
The investigator will stratify participants on worst pain intensity (<=5 and >5) and randomly assign 15 adults to attention control (stress/pain tracking; 12-min SCD experience discussion) and 15 adults to experimental (stress/pain tracking; 12-min GR video clip) groups.
The immediate intervention effects will be examined for pain (primary) and stress (secondary) outcomes. Vital signs for determining relaxation responses (mediators) will be collected immediately before and after the 12-min interventions.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Feasibility of the PAINReportIt Guided Relaxation Intervention for Pain and Stress Symptoms in Adult Outpatients With Sickle Cell Disease|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||February 23, 2017|
|Actual Study Completion Date :||March 1, 2017|
Experimental: Guided Relaxation video clip
This intervention is a 12-minute guided audio-visual relaxation intervention delivered at the baseline visit to determine the immediate effects of guided relaxation intervention on stress and pain in outpatients with sickle cell disease.
Behavioral: Guided Relaxation video clip
This intervention is a 12-minute guided audio-visual relaxation intervention.
Sickle cell experience discussion
Attention Control Group: This intervention is a 12-minute sickle cell disease experience discussion. In this computer-based discussion, patients talk about their sickle cell disease experience. The audio-taped questions and onscreen directions were programmed for self-administration. 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
This intervention is a 12-minute computer-administered sickle cell disease experience discussion.
- Current pain [ Time Frame: Immediate (baseline) ]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.
- Current stress [ Time Frame: Immediate (baseline) ]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.
- Physiologic markers of relaxation (pulse, respiration, finger temperature) [ Time Frame: Immediate (baseline) ]Physiological markers of relaxation (pulse, respiration, finger temperature) will be measured using a standard vital sign measuring device. We will estimate intervention effects using regression analysis. 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Has SCD diagnosis;
- Reports pain 3 or greater in the previous 24 hours (0-10 scale)
- Receives care at the University of Florida (UF) Health/Shands
- Speaks and reads English
- 18 years of age or older
- Self-identifies as being of African or Hispanic descent
- Legally blind
- Physically or cognitively unable to complete study measures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729363
|United States, Florida|
|University of Florida Hematology Clinic-Medical Plaza|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Miriam O Ezenwa, PhD, RN||University of Florida|
|Responsible Party:||University of Florida|
|Other Study ID Numbers:||
|First Posted:||April 6, 2016 Key Record Dates|
|Last Update Posted:||January 22, 2020|
|Last Verified:||January 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn