Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease

University of Illinois

Status: Completed

Conditions: Sickle Cell Disease; Stress

Treatments: Behavioral: Guided audio-visual relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT02501447

Protocol # 2012-1084

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Guided audio-visual relaxation group

Experimental group

Description:

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.

Treatment:

Behavioral: Guided audio-visual relaxation

Attention Control group

No Intervention group

Description:

For the attention control group, subjects engaged in a 12-min computer-based discussion about their sickle cell disease (SCD) experience. The audio-taped questions and onscreen directions were programmed for self-administration. Subjects' responses were captured via the microphone so that Data Collectors were not involved in this discussion process, and it was equivalent to the guided relation activity.