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Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease

Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02501447
Enrollment
28
Registered
2015-07-17
Start date
2013-11-30
Completion date
2014-11-30
Last updated
2015-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease, Stress

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.

Interventions

BEHAVIORALGuided audio-visual relaxation

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Current stressImmediate (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.
Current painImmediate (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.
Average stress intensityShort-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.
Composite pain indexShort-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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026