Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease

Stress Clinical Trial

Official title:

Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501447
• Other study ID #: Protocol # 2012-1084
• Status: Completed
• Phase: N/A
• First received: July 13, 2015
• Last updated: July 15, 2015
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: July 2015
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease
• Stress

Intervention

Behavioral:
• Guided audio-visual relaxation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current stress	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.	Immediate (baseline)
Primary	Current pain	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.	Immediate (baseline)
Primary	Average stress intensity	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.	Short-term (2 weeks)
Primary	Composite pain index	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.	Short-term (2 weeks)