The Feasibility of the PAINReportIt Guided Relaxation Intervention-Outpatient

January 21, 2020 updated by: University of Florida

The Feasibility of the PAINReportIt Guided Relaxation Intervention for Pain and Stress Symptoms in Adult Outpatients With Sickle Cell Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Hematology Clinic-Medical Plaza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediate (baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediate (baseline)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediate (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

February 23, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201600042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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