The Feasibility of the PAINReportIt Guided Relaxation Intervention-Outpatient

Not Applicable

Completed

• Conditions: Stress; Pain; Sickle Cell Disease
• Interventions: Behavioral: Guided Relaxation video clip; Behavioral: Sickle Cell Disease Experience Discussion

• Registration Number: NCT02729363
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-03-31
• Study Start: 2016-04
• Study First Posted: 2016-04-06
• Primary Completion: 2017-02-23
• Study Completion: 2017-03-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided Relaxation video clip	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.
Sickle cell experience discussion	Sickle Cell Disease 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.

Primary Outcome Measures

Name	Time	Method
Current pain	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.

Secondary Outcome Measures

Name	Time	Method
Current stress	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.

Trial Locations

Locations (1)

University of Florida Hematology Clinic-Medical Plaza; 🇺🇸 Gainesville, Florida, United States