Ignite Creation Date:
2024-05-06 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03686176
Status:
TERMINATED
Last Update Posted:
2020-08-06
First Post:
2018-09-25
Brief Title:
Virtual Reality During Procedures in Pediatric Patients
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Virtual Reality During Procedures in Pediatric Patients
Status:
TERMINATED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Coronavirus COVID-19-related pause on all clinical research studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This stratified randomized controlled trial compared coping and distress between child life supported virtual reality engagement and child life support during painful procedures in the pediatric emergency department
Detailed Description:
Pediatric emergency rooms and hospitals are anxiety provoking and often painful places for pediatric patients and families Children of all ages present to the Johns Hopkins emergency room and are admitted to the hospital for a wide range of medical conditions many of which require medical interventions Many of these interventions are the source of anxiety and pain including burn debridement or dressing changes laceration repair or intravenous IV line placement The standard of care to reduce pain and improve coping during pediatric procedures ranges from no intervention to support from child life specialists
As an adjunct to the existing methods of promoting comfort during painful procedures non-invasive virtual reality VR therapy is showing promise as a means of distraction and coping with various medical procedures The user is transported into a relaxingdistracting VR environment that diverts users attention away from pain and anxiety VR has demonstrated efficacy in the reduction of pain and anxiety experienced by individuals undergoing anxiety and pain inducing proceduresWhile there is early data from small or narrow populations that show some improvement in pain and anxiety with VR use during pediatric procedures some studies show no improvement No studies to date have used objective outcome measures of coping which may be more clinically meaningful
The investigators propose to fill this gap in the literature with a randomized controlled un-blinded study of coping and distress between virtual reality engagement and child life support in pediatric patients undergoing painful medical procedures
As an adjunct to the existing methods of promoting comfort during painful procedures non-invasive virtual reality VR therapy is showing promise as a means of distraction and coping with various medical procedures The user is transported into a relaxingdistracting VR environment that diverts users attention away from pain and anxiety VR has demonstrated efficacy in the reduction of pain and anxiety experienced by individuals undergoing anxiety and pain inducing proceduresWhile there is early data from small or narrow populations that show some improvement in pain and anxiety with VR use during pediatric procedures some studies show no improvement No studies to date have used objective outcome measures of coping which may be more clinically meaningful
The investigators propose to fill this gap in the literature with a randomized controlled un-blinded study of coping and distress between virtual reality engagement and child life support in pediatric patients undergoing painful medical procedures
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