Ignite Creation Date:
2024-05-06 @ 10:37 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03304769
Status:
UNKNOWN
Last Update Posted:
2017-10-09
First Post:
2017-09-28
Brief Title:
Virtual Reality Distraction During Pediatric Intravenous Line Placement
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
Virtual Reality Distraction During Pediatric Intravenous Line Placement A Prospective Randomized Comparison Study
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
RECRUITING
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:
This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department by comparing the first stick success rate total number of attempts and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life individuals with special training in aiding and augmenting pediatric coping skills is not available The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups Finally by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration
Detailed Description:
Children often describe procedures involving needles as the most stressful portion of the hospital experience 12 Many studies involving the perception of pain have highlighted the importance of attention for the perception of pain and conversely the benefit of distraction for decreasing pain perception 34 Virtual reality technologies VR have been shown to mitigate the experience of pain and anxiety in patients undergoing procedures in a number of different ways 56 While small studies have demonstrated the use of VR to be effective in diminishing pain during intravenous IV placement for outpatient imaging in pediatric patients aged 8-12 there have not been large-scale studies assessing the use of VR during IV placement in the Pediatric Emergency Department 7 Studies examining the use of VR during venipuncture and IV placement also frequently focus on self-reported or parent-reported pain rather than objectively quantifying number of IV sticks and time to successful IV placement8 Additionally the pediatric age ranges which benefit from VR have not been well-established with some studies citing benefits only in patients over 10 years of age and others showing improvements in all age groups7910
This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department by comparing the first stick success rate total number of attempts and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life individuals with special training in aiding and augmenting pediatric coping skills is not available The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups Finally by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration
This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department by comparing the first stick success rate total number of attempts and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life individuals with special training in aiding and augmenting pediatric coping skills is not available The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups Finally by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration
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