Clinical trial NCT02729363: The Feasibility of the PAINReportIt Guided Relaxation Intervention-Outpatient
Official title: The Feasibility of the PAINReportIt Guided Relaxation Intervention for Pain and Stress Symptoms in Adult Outpatients With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Stress
Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 30
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: Our goal is to improve the self-management of pain and stress in adult outpatients with sickle cell disease (SCD) by determining the feasibility of a self-managed 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. Little is known about the effects or mechanisms of GR on pain and stress, in adults with SCD. 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 paucity 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 outpatients with SCD. GR is an intervention where outpatients with SCD are directed to listen to and view audio-visual recordings while they visualize themselves being immersed in that scene.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Legally blind
* Physically or cognitively unable to complete study measures

Primary outcomes:
measure: Current pain
timeFrame: Immediate (baseline)
Secondary outcomes:
measure: Current stress
timeFrame: Immediate (baseline)
Other outcomes:
measure: Physiologic markers of relaxation (pulse, respiration, finger temperature)
timeFrame: Immediate (baseline)
Locations:
city: Gainesville
country: United States
facility: University of Florida Hematology Clinic-Medical Plaza
state: Florida
Study officials:
affiliation: University of Florida
name: Miriam O Ezenwa, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ezenwa MO, Yao Y, Nguyen MT, Mandernach MW, Hunter CT, Yoon SL, Fedele D, Lucero RJ, Lyon D, Wilkie DJ. Randomized Pilot Study: A Mobile Technology-based Self-management Intervention for Sickle Cell Pain. West J Nurs Res. 2020 Aug;42(8):629-639. doi: 10.1177/0193945919878821. Epub 2019 Oct 4.