The Feasibility of the PAINReportIt Guided Relaxation Intervention-Outpatient
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Anemia |
| Therapuetic Areas: | Hematology, Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2018 |
| Start Date: | April 2016 |
| End Date: | March 1, 2017 |
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.
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.
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.
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.
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
We found this trial at
1
site
Gainesville, Florida 32610
Phone: 352-273-7832
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