Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515873
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Seniors Intraoperative Management Under Locoregional Anesthesia Integrating Virtual Reality
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Acceptability of Virtual Reality Headsets During Surgery Under Spinal Anesthesia in Elderly Patients Seniors Intraoperative Management Under Locoregional Anesthesia Integrating Virtual Reality SILVR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SILVR
Brief Summary:
This study aims to evaluate the acceptability of intraoperative virtual reality in elderly patients under spinal anesthesia
Detailed Description:
For the past decade virtual reality VR has been expanding across various medical applications fields Regarding surgery and anesthesia VR was used during different procedures such as orthopedics surgery of the upper extremities under regional anesthesia blocks hip and knee arthroplasties dental care and induction of anesthesia especially in pediatrics Using VR during surgery can reduce pain anxiety quantity of sedation used and time in the PACU
Unfortunately the adherence to VR specifically among adults aged 65 and over is not thoroughly defined in the scientific literature and should be investigated in order to determine the spectrum of use of this tool However VR has been used as an anxiolytic and analgesic in elderly patients during rehabilitation exercises such as physiotherapy treatment after surgery or vestibular rehabilitation after experiencing dizziness
The main objective of this study is to determine if a virtual reality headset can be tolerated during surgery under spinal anesthesia in patients aged 65 years and older 55 patients over 65 years old having an elective surgery will be recruited
The total time for which the patient will wear the virtual reality headset during the surgery will be measured and a semi-structured post-operative questionnaire will assess the overall patient satisfaction
Simultaneously the influence of the type of scenario chosen on the patients tolerance to the VR headset will be established secondary objective details listed below
Study Center Maisonneuve-Rosemont Hospital Integrated University Health and Social Services Centre CIUSSS de lEst de lIle de Montreal CEMTL University of Montreal Montreal Quebec Canada
Unfortunately the adherence to VR specifically among adults aged 65 and over is not thoroughly defined in the scientific literature and should be investigated in order to determine the spectrum of use of this tool However VR has been used as an anxiolytic and analgesic in elderly patients during rehabilitation exercises such as physiotherapy treatment after surgery or vestibular rehabilitation after experiencing dizziness
The main objective of this study is to determine if a virtual reality headset can be tolerated during surgery under spinal anesthesia in patients aged 65 years and older 55 patients over 65 years old having an elective surgery will be recruited
The total time for which the patient will wear the virtual reality headset during the surgery will be measured and a semi-structured post-operative questionnaire will assess the overall patient satisfaction
Simultaneously the influence of the type of scenario chosen on the patients tolerance to the VR headset will be established secondary objective details listed below
Study Center Maisonneuve-Rosemont Hospital Integrated University Health and Social Services Centre CIUSSS de lEst de lIle de Montreal CEMTL University of Montreal Montreal Quebec Canada
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None