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NCT02729363 · ClinicalTrials.gov registry record · NA
The Feasibility of the PAINReportIt Guided Relaxation Intervention-Outpatient
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT02729363: Completed NA study, sponsored by University of Florida.
NCT02729363 is a NA study that has completed, run by University of Florida. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02729363, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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.
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.
Interventions
- BEHAVIORAL Guided Relaxation video clip
- BEHAVIORAL Sickle Cell Disease Experience Discussion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-04 |
| Est. Completion | 2017-03-01 |
| Phase | NA |
What the finished NCT02729363 record still lists
NCT02729363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Guided Relaxation video clip is the first listed.
NCT02729363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02729363 about?
NCT02729363 is a clinical study titled "The Feasibility of the PAINReportIt Guided Relaxation Intervention-Outpatient". 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 ...
What is the current status of trial NCT02729363?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2016-04. Estimated completion is 2017-03-01.
What interventions are being tested in trial NCT02729363?
The interventions under investigation include: Guided Relaxation video clip (BEHAVIORAL), Sickle Cell Disease Experience Discussion (BEHAVIORAL).
Who is sponsoring clinical trial NCT02729363?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02729363's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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