Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04666506
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2020-12-01
Brief Title:
Relaxation-VR Implementation of Virtual Reality for Children in Hospital
Sponsor:
Thomas More University of Applied Sciences
Organization:
Thomas More University of Applied Sciences
Study Overview
Official Title:
Relaxation-VR Implementation of Virtual Reality for Children in Hospital
Status:
COMPLETED
Status Verified Date:
2021-05
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:
Relaxation-VR
Brief Summary:
Although on an international level accumulating evidence supports the feasibility and effectiveness of VR for pain and anxiety management in Belgium adoption of VR in clinical practice is limited and local trials are scarce In order to improve translation from research to practice the current study will focus on the feasibility acceptability tolerability and preliminary effectiveness of Relaxation-VR a VR application aiming to reduce anxiety and pain for children admitted to hospital as experienced by both patients and clinical staff This study will take place at the paediatric wards of two hospitals interested in adopting this innovative technology for improving both patient care eg anxiety and pain reduction and staff workload eg shorter procedure times UZ Brussel and AZ Sint-Maarten
Detailed Description:
Current pain and anxiety management for children in hospital includes pharmacological analgesia eg opioid therapy with potential negative side effects In addition a non-pharmacological approach involves various distraction techniques either passive eg music movies or active eg interactive toys electronic games storytelling by the nursing staff However these distraction techniques can often be time consuming for the already busy and even over-demanded nursing staff
A combination of distraction extinction learning cognitive-behavioral principles mindful meditation stress reduction gate-control theory and the spotlight theory of attention is believed to be the mechanism behind VRs effectiveness in pain management Accumulating evidence supports VR as a feasible and effective method to alleviate anxiety and pain for paediatric patients during lumbar punctures intravenous injections burn wound care and rehabilitation In particular a recent meta-analysis reported that the use of VR was significantly more effective in reducing pain 14 studies and anxiety 7 studies than care as usual CAU with large effect size Moreover for chest radiography the use of VR has also significantly reduced procedure time while increasing patient satisfaction As such adding the use of VR to standard pain and anxiety management methods might improve both effectiveness and efficiency of current practice
Although on an international level accumulating evidence supports the feasibility and effectiveness of VR for pain and anxiety management in Belgium adoption of VR in clinical practice is limited and local trials are scarce In order to improve translation from research to practice the current study will focus on the feasibility acceptability tolerability and preliminary effectiveness of Relaxation-VR a VR application aiming to reduce anxiety and pain for children admitted to hospital as experienced by both patients and clinical staff This study will take place at the paediatric wards of two hospitals interested in adopting this innovative technology for improving both patient care eg anxiety and pain reduction and staff workload eg shorter procedure times UZ Brussel and AZ Sint-Maarten
A combination of distraction extinction learning cognitive-behavioral principles mindful meditation stress reduction gate-control theory and the spotlight theory of attention is believed to be the mechanism behind VRs effectiveness in pain management Accumulating evidence supports VR as a feasible and effective method to alleviate anxiety and pain for paediatric patients during lumbar punctures intravenous injections burn wound care and rehabilitation In particular a recent meta-analysis reported that the use of VR was significantly more effective in reducing pain 14 studies and anxiety 7 studies than care as usual CAU with large effect size Moreover for chest radiography the use of VR has also significantly reduced procedure time while increasing patient satisfaction As such adding the use of VR to standard pain and anxiety management methods might improve both effectiveness and efficiency of current practice
Although on an international level accumulating evidence supports the feasibility and effectiveness of VR for pain and anxiety management in Belgium adoption of VR in clinical practice is limited and local trials are scarce In order to improve translation from research to practice the current study will focus on the feasibility acceptability tolerability and preliminary effectiveness of Relaxation-VR a VR application aiming to reduce anxiety and pain for children admitted to hospital as experienced by both patients and clinical staff This study will take place at the paediatric wards of two hospitals interested in adopting this innovative technology for improving both patient care eg anxiety and pain reduction and staff workload eg shorter procedure times UZ Brussel and AZ Sint-Maarten
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