Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06039462
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2023-08-21
Brief Title:
Virtual Reality Distraction Therapy in Paediatrics
Sponsor:
The Leeds Teaching Hospitals NHS Trust
Organization:
The Leeds Teaching Hospitals NHS Trust
Study Overview
Official Title:
Improve Patient Safety and Wellbeing in Leeds Children Hospital for Patients Undergoing Procedures Through Use of Virtual Reality Distraction Therapy VRDT and Improve Their Overall Experience
Status:
COMPLETED
Status Verified Date:
2023-09
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:
For many children in hospital having blood tests or cannulation is a significantly distressing event physically psychologically and emotionally Use of distraction during invasive procedures is already common practice in paediatrics to improve the experience both for the child and parents Use of Virtual Reality VR and VR Distraction Therapy VRDT is a relatively new concept but has already shown promising results in studies
VR offers an interactive distraction technique a contrast to the passive distraction of reading a book or playing games on a tablet and VR is thought to alter pain perception and the childs interpretation of pain signals Cochrane Library - Virtual reality simulation for reducing pain in children
The project aims to collect data about venepuncture cannulation long lines - qualitative and quantitative data - from children and parents This studyl compares current standard practice with VR distraction therapy
VR offers an interactive distraction technique a contrast to the passive distraction of reading a book or playing games on a tablet and VR is thought to alter pain perception and the childs interpretation of pain signals Cochrane Library - Virtual reality simulation for reducing pain in children
The project aims to collect data about venepuncture cannulation long lines - qualitative and quantitative data - from children and parents This studyl compares current standard practice with VR distraction therapy
Detailed Description:
Not all studies raise significant issues Some studies may have straightforward ethical or other issues that can be identified and managed routinely Others may present significant issues requiring further consideration by a REC HRA or other review body as appropriate to the issue Studies that present a minimal risk to participants may raise complex organisational or legal issues You should try to consider all the types of issues that the different reviewers may need to consider
VR companies do not recommend use of their headsets in children under 13 years of age I do not anticipate including 8-12 year olds in the study causing any issues based on experience and advice from relevant experts see below In summary the age cut off is borne of lack of evidence for long-term effects of VR on visual or brain development rather than specific concerns or evidence existing to inform the age cut off
Childrens Hospital Colorado US use VR in children of 6 years and above Speaking with their Associate Professor of Paediatrics the age limitation is not derived from medical standards or concerns They discussed with their Neurology department who agreed there is no age-specific concern that warrants the 12 year cut-off and they also rely upon the professional expertise of Child Life Specialists who routinely screen toys and devices for age-appropriate application They have used VR in healthcare for children several hundred times and have no concerns about the age cut off the VR companies suggest
Stanford University School of Medicine US run the highest volume clinical VR therapy program in the US with thousands of children each year receiving VR Their department similarly does not exclude under 13 year olds from their program
Clinicians experienced with VR in the UK have spoken to VR companies involved in their studies and the information gives was that there no long-term data on VR and its effects on brain and visual development These clinicians also use VR on children aged 5-6 years and above
I have met with the VR company Dubit Limited which shows in its global trends data that children much younger than 13 are already using VR The publication Children and Virtual Reality Emerging Possibilities and Challenges contains data from studies looking at the 8-12 year old age group there is not any current evidence of adverse events in this age group though transient change to visual function has been seen only in a minority of VR users in this age group
VR companies do not recommend use of their headsets in children under 13 years of age I do not anticipate including 8-12 year olds in the study causing any issues based on experience and advice from relevant experts see below In summary the age cut off is borne of lack of evidence for long-term effects of VR on visual or brain development rather than specific concerns or evidence existing to inform the age cut off
Childrens Hospital Colorado US use VR in children of 6 years and above Speaking with their Associate Professor of Paediatrics the age limitation is not derived from medical standards or concerns They discussed with their Neurology department who agreed there is no age-specific concern that warrants the 12 year cut-off and they also rely upon the professional expertise of Child Life Specialists who routinely screen toys and devices for age-appropriate application They have used VR in healthcare for children several hundred times and have no concerns about the age cut off the VR companies suggest
Stanford University School of Medicine US run the highest volume clinical VR therapy program in the US with thousands of children each year receiving VR Their department similarly does not exclude under 13 year olds from their program
Clinicians experienced with VR in the UK have spoken to VR companies involved in their studies and the information gives was that there no long-term data on VR and its effects on brain and visual development These clinicians also use VR on children aged 5-6 years and above
I have met with the VR company Dubit Limited which shows in its global trends data that children much younger than 13 are already using VR The publication Children and Virtual Reality Emerging Possibilities and Challenges contains data from studies looking at the 8-12 year old age group there is not any current evidence of adverse events in this age group though transient change to visual function has been seen only in a minority of VR users in this age group
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