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NCT02729350 · ClinicalTrials.gov registry record · NA
The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT
A NA study of Pain and Sickle Cell Disease, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT02729350: Completed NA study of Pain and Sickle Cell Disease, sponsored by University of Florida.
NCT02729350 is a NA study of Pain and Sickle Cell Disease that has completed, run by University of Florida. The registered enrollment target is 46 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02729350, a NA study of Pain and Sickle Cell Disease, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this research study is to improve the self-management of pain, stress, and cognitive/affective symptoms that may result in adult inpatients with sickle cell disease (SCD) by determining the feasibility of a self-management 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, particularly, in inpatient settings. Little is known about the effects or mechanisms of GR on pain, stress, and cognitive/affective symptoms in adults with SCD hospitalized with pain. 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 dearth 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 inpatients with SCD. GR is an intervention where inpatients with SCD are directed to listen to and view audio-visual recordings while they visualize themselves being immersed in that scenario.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Guided Relaxation video clip
- BEHAVIORAL Sickle Cell Disease Experience Discussion
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2016-04 |
| Est. Completion | 2019-03 |
| Phase | NA |
What the finished NCT02729350 record still lists
NCT02729350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (85% lower).
The record links to 3 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Guided Relaxation video clip is the first listed.
NCT02729350 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02729350 about?
NCT02729350 is a clinical study titled "The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT". The goal of this research study is to improve the self-management of pain, stress, and cognitive/affective symptoms that may result in adult inpatients with sickle cell disease (SCD) by determining the feasibility of a self-management guided relaxation (GR) stress reduction intervention using a tabl...
What is the current status of trial NCT02729350?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2016-04. Estimated completion is 2019-03.
What conditions does trial NCT02729350 study?
This clinical trial studies the following conditions: Pain, Sickle Cell Disease, Stress.
What interventions are being tested in trial NCT02729350?
The interventions under investigation include: Guided Relaxation video clip (BEHAVIORAL), Sickle Cell Disease Experience Discussion (BEHAVIORAL).
Who is sponsoring clinical trial NCT02729350?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02729350 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02729350's enrollment target sits among peer trials
46 268th of 374 higher than 104 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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