Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease

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

Tracking Information

• First Submitted Date: July 13, 2015
• First Posted Date: July 17, 2015
• Last Update Posted Date: July 17, 2015
• Study Start Date: November 2013
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 15, 2015)

• 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.
• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease
• Official Title: Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Sickle Cell Disease
• Stress

• Intervention: Behavioral: Guided audio-visual relaxation

Study Arms

• 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.
  Intervention: 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.

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 15, 2015): 28
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02501447
• Other Study ID Numbers: Protocol # 2012-1084
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Miriam O. Ezenwa, University of Illinois at Chicago
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Illinois at Chicago
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Miriam O Ezenwa, PhD, RN; University of Illinois at Chicago

• PRS Account: University of Illinois at Chicago
• Verification Date: July 2015