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The Feasibility of the PAINReportIt Guided Relaxation Intervention-Outpatient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729363
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief Summary:
Our goal is to improve the self-management of pain and stress in adult outpatients with sickle cell disease (SCD) by determining the feasibility of a self-managed guided relaxation (GR) stress reduction intervention using a tablet-based mobile device. Currently, opioid analgesics are primarily used to treat SCD pain while self-managed behavioral modalities such as GR, are rarely used. Little is known about the effects or mechanisms of GR on pain and stress, in adults with SCD. Emerging evidence from the hypothalamic pituitary adrenal (HPA) axis theory offer insights for understanding the mechanisms. Adding GR as a supplement to analgesic therapies will address the paucity of self-management strategies for controlling pain in SCD. GR is a simple and cost-effective non-drug intervention that could reduce pain and stress in outpatients with SCD. GR is an intervention where outpatients with SCD are directed to listen to and view audio-visual recordings while they visualize themselves being immersed in that scene.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Stress Pain Behavioral: Guided Relaxation video clip Behavioral: Sickle Cell Disease Experience Discussion Not Applicable

Detailed Description:

The investigator will recruit adult outpatients with sickle cell disease (SCD) from the University of Florida Health Hematology Clinics and conduct study visits in a research room located at the College of nursing.

The investigator will stratify participants on worst pain intensity (<=5 and >5) and randomly assign 15 adults to attention control (stress/pain tracking; 12-min SCD experience discussion) and 15 adults to experimental (stress/pain tracking; 12-min GR video clip) groups.

The immediate intervention effects will be examined for pain (primary) and stress (secondary) outcomes. Vital signs for determining relaxation responses (mediators) will be collected immediately before and after the 12-min interventions.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Feasibility of the PAINReportIt Guided Relaxation Intervention for Pain and Stress Symptoms in Adult Outpatients With Sickle Cell Disease
Study Start Date : April 2016
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Guided Relaxation video clip
This intervention is a 12-minute guided audio-visual relaxation intervention delivered at the baseline visit to determine the immediate effects of guided relaxation intervention on stress and pain in outpatients with sickle cell disease.
 Behavioral: Guided Relaxation video clip
This intervention is a 12-minute guided audio-visual relaxation intervention.
Sickle cell experience discussion
Attention Control Group: This intervention is a 12-minute sickle cell disease experience discussion. In this computer-based discussion, patients talk about their sickle cell disease experience. The audio-taped questions and onscreen directions were programmed for self-administration. Subjects' responses will be captured via the microphone so that Data Collectors are not involved in this discussion process, and it is equivalent to the guided relaxation activity.
 Behavioral: Sickle Cell Disease Experience Discussion
This intervention is a 12-minute computer-administered sickle cell disease experience discussion.


Outcome Measures
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Primary Outcome Measures :
  1. Current pain [ Time Frame: Immediate (baseline) ]
    Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity scale: A 3-item scale that asks patients to report their pain now, worst, and average on a scale of 1 to 5 where 1 is "had no pain" and 5 is "very severe." We will estimate intervention effects using regression analysis.


Secondary 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 will estimate intervention effects using linear regression.


Other Outcome Measures:
  1. Physiologic markers of relaxation (pulse, respiration, finger temperature) [ Time Frame: Immediate (baseline) ]
    Physiological markers of relaxation (pulse, respiration, finger temperature) will be measured using a standard vital sign measuring device. We will estimate intervention effects using regression analysis. We expect to observe trends for the immediate GR effect in terms of decreases in relaxation indicators (respiration rate, heart rate) and increases in skin temperature.


Eligibility Criteria
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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:

  • Has SCD diagnosis;
  • Reports pain 3 or greater in the previous 24 hours (0-10 scale)
  • Receives care at the University of Florida (UF) Health/Shands
  • Speaks and reads English
  • 18 years of age or older
  • Self-identifies as being of African or Hispanic descent

Exclusion Criteria:

  • Legally blind
  • Physically or cognitively unable to complete study measures
Contacts and Locations
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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): NCT02729363


Locations
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United States, Florida
University of Florida Hematology Clinic-Medical Plaza
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Miriam O Ezenwa, PhD, RN University of Florida
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02729363    
Other Study ID Numbers: IRB201600042
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn