The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT



Status:Recruiting
Conditions:Chronic Pain, Anemia
Therapuetic Areas:Hematology, Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:April 2016
End Date:December 2020
Contact:Miriam O Ezenwa, PhD, RN
Email:moezenwa@ufl.edu
Phone:352-273-6344

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

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.

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.

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
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Miriam Ezenwa, PhD
Phone: 352-273-6344
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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