Ignite Creation Date:
2024-05-06 @ 2:33 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04356963
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2020-04-19
Brief Title:
Adjunct VR Pain Management in Acute Brain Injury
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Adjunct Virtual Reality Pain Management in Acute Brain Injury
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Severe and refractory pain after acute injury is a known-risk factor for chronic opioid use disorder In this study the investigators will use Virtual Reality VR immersion as a non-pharmacological adjunct to treat pain associated with acute traumatic injuries including traumatic brain injury The investigators hypothesize that VR therapy will decrease pain and reduce opioid use in patients with acute traumatic injuries including TBI
Detailed Description:
Each participant will undergo one VR session and two control sessions The VR session will take place in a commercially available VR environment the Blu and last 20-30 minutes VR Blu The control sessions will include a 2D-tablet based session that mimics the VR content Tablet Blu and a content-less placement of the VR headset VR Blank The order of these sessions will be randomized across participants are intended to complete all sessions
Each participant will complete a pre-study questionnaire to elicit their prior experience with the virtual reality as well as measures of gaming addictionengagement boredom and expectancy These scales will help us determine which patient-level factors predict response to VR Before and after each session participants will complete validated scales of pain nausea and anxiety Pre- and Post-VR opioid use will be recorded Basic vital signs including heart rate blood pressure and respiratory rate will be recorded before and after each session to monitor autonomic response Advanced measures of autonomic response will include heart rate variabilityand pupillometry metrics At the conclusion of all sessions participants will complete another questionnaire to document their subjective experience of using VR perceived effectiveness
Each participant will complete a pre-study questionnaire to elicit their prior experience with the virtual reality as well as measures of gaming addictionengagement boredom and expectancy These scales will help us determine which patient-level factors predict response to VR Before and after each session participants will complete validated scales of pain nausea and anxiety Pre- and Post-VR opioid use will be recorded Basic vital signs including heart rate blood pressure and respiratory rate will be recorded before and after each session to monitor autonomic response Advanced measures of autonomic response will include heart rate variabilityand pupillometry metrics At the conclusion of all sessions participants will complete another questionnaire to document their subjective experience of using VR perceived effectiveness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1UL1TR003098 | NIH | None | httpsreporternihgovquickSearch1UL1TR003098 |