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Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02501447
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : July 17, 2015
Sponsor:
Information provided by (Responsible Party):
Miriam O. Ezenwa, 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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Stress Behavioral: Guided audio-visual relaxation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease
Study Start Date : November 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Guided audio-visual relaxation
No Intervention: 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.



Primary Outcome Measures :
  1. Current stress [ Time Frame: 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.

  2. Current pain [ Time Frame: 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.

  3. Average stress intensity [ Time Frame: 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.

  4. Composite pain index [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501447


Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Miriam O Ezenwa, PhD, RN University of Illinois at Chicago

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Miriam O. Ezenwa, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02501447     History of Changes
Other Study ID Numbers: Protocol # 2012-1084
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn