Clinical trial NCT02729350: The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT
Official title: The Feasibility of the PAINReportIt Guided Relaxation Intervention for Pain and Stress in Adult Inpatients With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Stress
Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Current Pain
timeFrame: Immediate (Day 1 baseline) and Day 2-5
measure: Average pain intensity
timeFrame: Short-term (Day 5)
measure: Composite pain index
timeFrame: Short-term (Day 5)
Secondary outcomes:
measure: Current stress
timeFrame: Immediate (Day 1 baseline) and Days 2-5
measure: Average stress intensity
timeFrame: Short-term (Day 5)
Other outcomes:
measure: Physiologic markers of relaxation (pulse, respiration, finger temperature)
timeFrame: Immediate (baseline)
measure: Level of relaxation
timeFrame: Immediate (Day 1 baseline) and Day 2-5
measure: Perceived stress
timeFrame: Baseline
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Miriam O Ezenwa, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: