Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease

Not Applicable

Completed

• Conditions: Sickle Cell Disease; Stress
• Interventions: Behavioral: Guided audio-visual relaxation

• Registration Number: NCT02501447
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

Stress is known to trigger acute pain crisis of sickle cell disease (SCD). SCD is an inherited blood disorder that afflicts about 100,000 people in the United States, and is among the most common lethal genetic diseases in the United States. Though worldwide in distribution, in the US it is most commonly found in African Americans. Its best known complication is severe, recurrent relentless pain, often known as pain crisis. Non-drug treatment for SCD pain such as cognitive coping interventions have been shown to be effective for reducing SCD pain intensity, but they are complicated, multifaceted, and time-consuming. A simple and cost-effective alternative such as guided imagery (GI) could reduce the effect of stress on SCD pain. GI is an intervention where patients listen to and view audio-visual recordings while being directed to visualize themselves being immersed in that scene or scenario. There are no published studies on the use of GI as a simple stress coping intervention or tracking stress in a systematic manner as a trigger for SCD pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-07
• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-15
• Last Update Submitted: 2015-07-15
• Study First Posted: 2015-07-17
• Last Update Posted: 2015-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Adults 18 years of age or older,
• Diagnosis of SCD,
• Self-reported pain of at least 3 on a 0-10 scale related to SCD,
• Spoke and read English, and
• Self-identified as being of African or Hispanic descent.

Exclusion Criteria

• Legally blind or physically unable to complete procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided audio-visual relaxation group	Guided audio-visual relaxation	The guided relaxation (GR) intervention included a single 12-min GR video clip we administered to subjects at the baseline visit to determine the immediate effects of GR on stress and pain. The GR intervention also included six video clips, which ranged from 2 to 20 minutes in length to determine the short-term (2-week) effects of GR on stress and pain.

Primary Outcome Measures

Name	Time	Method
Current pain	Immediate (baseline)	PAINReportIt® Pain intensity scale: A 3-item scale that asks patients to report their current, least, and worst pain intensity today, on a scale of 0 to 10, where 0 is "no pain" and 10 is "pain as bad as it could be." We estimated intervention effects using linear regression with bootstrapping.
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 estimated intervention effects using linear regression with bootstrapping.
Composite pain index	Short-term (2 weeks)	PAINReportIt® Composite pain index (CPI): A a multidimensional representation of pain calculated by averaging the individual proportional scores for each of the four pain dimensions: (1) number of pain sites; (2) pain intensity; (3) total pain rating index (from the McGill Pain Questionnaire \[MPQ\], pain quality); and (4) pain pattern score. the scores for the CPI range from 0 to 100. We estimated intervention effects using linear regression with bootstrapping.
Average stress intensity	Short-term (2 weeks)	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 averaged the three scores to create an average stress intensity score. We estimated intervention effects using linear regression with bootstrapping.