Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease

NCT ID: NCT02501447

Last Updated: 2015-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-11-30

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.

Conditions

Sickle Cell Disease; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Guided audio-visual relaxation group

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.

Group Type: EXPERIMENTAL

Guided audio-visual relaxation

Intervention Type: BEHAVIORAL

Attention Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Guided audio-visual relaxation

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Miriam O. Ezenwa

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miriam O Ezenwa, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

References

Ezenwa MO, Yao Y, Engeland CG, Molokie RE, Wang ZJ, Suarez ML, Wilkie DJ. A randomized controlled pilot study feasibility of a tablet-based guided audio-visual relaxation intervention for reducing stress and pain in adults with sickle cell disease. J Adv Nurs. 2016 Jun;72(6):1452-63. doi: 10.1111/jan.12895. Epub 2016 Jan 15.

Reference Type: DERIVED

PMID: 26768753 (View on PubMed)

Other Identifiers

Protocol # 2012-1084

Identifier Type: -

Identifier Source: org_study_id