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NCT03155607 · ClinicalTrials.gov registry record · NA
Novel Virtual Reality for Burn Wound Care Pain in Adolescents
A NA study, sponsored by University of Arkansas.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
NCT03155607 is a NA study that has completed, run by University of Arkansas. The registered enrollment target is 43 participants.
The verdict
NCT03155607, a NA study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
Study Summary
Burn wounds cause intense, complex pain, and subsequent burn wound care causes further intense, episodic pain that is often unrelieved by opioid and non-opioid medications, resulting in under-treatment of pain. Further, opioid analgesics can have untoward side effects including respiratory depression, nausea, constipation, pruritus, drowsiness, lethargy, dependence, and induced hyperalgesia. As one of the most severe types of pain, burn wound care pain adds to the trauma pediatric patients already experience from the burn itself impacting quality of life with subsequent behavioral and maladaptive responses, such as agitation, anger, anxiety, hyperactivity, uncooperativeness, aggression, and dissociation. Lack of control over the procedure, pain memory, anxiety in anticipation of the repeated painful nature of the procedure, and transmission of clinician distress associated with inflicting procedural pain on the child contribute to the pain perceived. Virtual reality (VR) shows great promise as an engaging, interactive, effective non-pharmacologic intervention for various painful healthcare procedures, including burn wound care, therapies, and chronic pain conditions, despite equivocal findings, perhaps due to methodological issues. Designs of many studies of VR during burn wound care have been case studies or carefully controlled within-subject designs; sample sizes have been small. Recommendations for ongoing research include conducting more rigorous studies including randomized controlled trials (RCTs), repeat design studies, testing VR throughout the healthcare procedure, comparing VR to other distraction interventions; and using larger sample sizes. Primary Aim 1: Compare the effectiveness of age-appropriate, consumer available, high technology, interactive VR with standard care (SC) on adolescents' acute procedural pain intensity perception during burn wound care treatment in the ambulatory outpatient clinic setting.
Interventions
- BEHAVIORAL Virtual Reality Distraction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-01-04 |
| Est. Completion | 2021-12-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03155607
The ClinicalTrials.gov registry entry for NCT03155607 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Virtual Reality Distraction is the first listed.
NCT03155607 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03155607 about?
NCT03155607 is a clinical study titled "Novel Virtual Reality for Burn Wound Care Pain in Adolescents". Burn wounds cause intense, complex pain, and subsequent burn wound care causes further intense, episodic pain that is often unrelieved by opioid and non-opioid medications, resulting in under-treatment of pain. Further, opioid analgesics can have untoward side effects including respiratory depressio...
What is the current status of trial NCT03155607?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2018-01-04. Estimated completion is 2021-12-02.
What interventions are being tested in trial NCT03155607?
The interventions under investigation include: Virtual Reality Distraction (BEHAVIORAL).
Who is sponsoring clinical trial NCT03155607?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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