Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522711
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Virtual Reality for Anxiolysis and Pharmacological Sparing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Virtual Reality as a Strategy for Intra-operatory Anxiolysis and Pharmacological Sparing in Patients Undergoing Breast Surgeries the V-RAPS Randomized Controlled Trial
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:
V-RAPS
Brief Summary:
The goal of this clinical trial is to learn if virtual reality can reduce propofol requirements in adult female patients undergoing elective breast surgery under regional anesthesia The main question it aims to answer is
Can virtual reality immersion reduce intra-operative propofol requirements in adult female patients undergoing elective breast surgery under regional anesthesia
Researchers will compare time and weight-adjusted average propofol requirements in both the intervention group and the control group to see if there is a reduction in sedative usage in the group using the virtual reality device
Participants will be randomly assigned to either a virtual reality intervention group or a control group
The patients in the virtual reality group will have a virtual reality headset on during the surgery with a preselected scenario of their choice
Both groups will have access to patient-controlled sedation under the supervision of an anesthesiologist and will be permitted to self-administer propofol boluses as needed
Can virtual reality immersion reduce intra-operative propofol requirements in adult female patients undergoing elective breast surgery under regional anesthesia
Researchers will compare time and weight-adjusted average propofol requirements in both the intervention group and the control group to see if there is a reduction in sedative usage in the group using the virtual reality device
Participants will be randomly assigned to either a virtual reality intervention group or a control group
The patients in the virtual reality group will have a virtual reality headset on during the surgery with a preselected scenario of their choice
Both groups will have access to patient-controlled sedation under the supervision of an anesthesiologist and will be permitted to self-administer propofol boluses as needed
Detailed Description:
Virtual reality VR has carved out a growing place for itself in our leisure activities video games and even in medicine Recent studies show that VR can reduce anxiety and pain in patients undergoing uncomfortable care eg wound care dental care venous access While the population most frequently investigated is pediatric the benefits can be extended to other populations The operating room is uncommon due to the type of procedure and the older patient profile Yet with the democratization of regional and neuraxial anesthesia VR could improve the patient experience in the operating room
The main objective of this study is to explore the impact of VR on intravenous IV sedation requirements in adult patients undergoing breast surgery under paravertebral PV block The hypothesis is that VR will serve as an effective distraction in the operative context reducing the need for pharmacology In parallel multiple secondary objectives will also be explored such as the evaluation of the tolerance to the VR headset the impact of the chosen type of scenario on the primary outcome the incidence of adverse effects the variation of the Nociception Level Index NOL index in awake patients as well as overall patient satisfaction
This single center open-label randomized controlled trial will be conducted in a Canadian academic hospital 100 patients above the age of 18 years undergoing breast surgery mastectomy reduction augmentation reconstruction etc under regional anesthesia specifically paravertebral block will be included in this study Patients will be randomized either to the intervention group or the control group The intervention group will have a VR helmet and the control group a standard treatment Both will have access to patient-controlled sedation PCS self-administering their own sedation under clinical observation Patients in the VR group will be able to choose before the procedure begins between 3 different VR environments and will also be allowed to switch between these environments during the surgery The primary outcome of this study will be the time-weighted dose of propofol sedative self-administered during the procedure Secondary outcomes will include patient satisfaction premature removal of VR helmet presence of nausea desaturation hypotension and post-anesthesia monitoring time
The main objective of this study is to explore the impact of VR on intravenous IV sedation requirements in adult patients undergoing breast surgery under paravertebral PV block The hypothesis is that VR will serve as an effective distraction in the operative context reducing the need for pharmacology In parallel multiple secondary objectives will also be explored such as the evaluation of the tolerance to the VR headset the impact of the chosen type of scenario on the primary outcome the incidence of adverse effects the variation of the Nociception Level Index NOL index in awake patients as well as overall patient satisfaction
This single center open-label randomized controlled trial will be conducted in a Canadian academic hospital 100 patients above the age of 18 years undergoing breast surgery mastectomy reduction augmentation reconstruction etc under regional anesthesia specifically paravertebral block will be included in this study Patients will be randomized either to the intervention group or the control group The intervention group will have a VR helmet and the control group a standard treatment Both will have access to patient-controlled sedation PCS self-administering their own sedation under clinical observation Patients in the VR group will be able to choose before the procedure begins between 3 different VR environments and will also be allowed to switch between these environments during the surgery The primary outcome of this study will be the time-weighted dose of propofol sedative self-administered during the procedure Secondary outcomes will include patient satisfaction premature removal of VR helmet presence of nausea desaturation hypotension and post-anesthesia monitoring time
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