Clinical Trial Radar

Name: 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)
Creator: Ciusss de L'Est de l'Île de Montréal
Published: 2024-07-23
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT06515873 (SILVR) for Virtual Reality, Spinal Anesthesia is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Seniors' Intraoperative Management Under Locoregional Anesthesia Integrating Virtual Reality (SILVR) 55 Senior-Focused Virtual

Not yet recruiting

Clinical Trial NCT06515873 (SILVR) is an interventional study for Virtual Reality, Spinal Anesthesia and is currently not yet recruiting. Enrollment is planned to begin on 1 July 2024 and continue until the study accrues 55 participants. Led by Ciusss de L'Est de l'Île de Montréal, this study is expected to complete by 1 March 2025. The latest data from ClinicalTrials.gov was last updated on 23 July 2024.

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...Show More

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)

Conditions

Virtual RealitySpinal Anesthesia

Publications

Boutin J, Kamoonpuri J, Faieghi R, Chung J, de Ribaupierre S, Eagleson R. Smart haptic gloves for virtual reality surgery simulation: a pilot study on external ventricular drain training. Front Robot AI. 2024 Jan 10;10:1273631. doi: 10.3389/frobt.2023.1273631. eCollection 2023.

Other Study IDs

SILVR
2025-3770

NCT ID Number

NCT06515873

Start Date (Actual)

2024-07

Last Update Posted

2024-07-23

Completion Date (Estimated)

2025-03

Enrollment (Estimated)

Study Type

Interventional

PHASE

N/A

Status

Not yet recruiting

Keywords

Elderly patient
Acceptability

Primary Purpose

Supportive Care

Design Allocation

N/A

Interventional Model

Single Group

Masking

None (Open Label)

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
Experimentala group of 55 patients	Virtual Reality Headset The virtual reality headset, which will display one of the 3 available scenarios, will be placed on the patient head during a surgery under spinal anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's tolerance to headset	The primary endpoint is the patient's tolerance to virtual reality defined by the headset to be worn for more than or equal to 30 minutes by the participant	Intraoperative (from T0 = the patient puts on the headset until Tend = 30 minutes after T0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety before the surgery	Level of anxiety before the surgery evaluated by the Amsterdam Preoperative Anxiety and Information Scale (a scale from 1 - not at all to 5 - extremely, 6 questions).	preoperative (from T0 = the patient arrives at the hospital the morning of the surgery until Tend = the patient enters the operating room, about 2 hours)
Total of time before the patient's first request to interrupt the experiment	The total time in minutes, both in absolute and relative to the duration of the surgery, from the start of the initially chosen scenario to the first request to interrupt the experiment.	intraoperative (from T0 = the patient puts on the headset at the beginning of the surgery until Tend = the patient first asks to interrupt the experiment during the surgery, about 45 minutes - depending on the person and the surgery)
Total of time during which the patient wears the VR headset during surgery.	The total time in minutes, both in absolute and relative to the duration of the surgery, from the start of the initially chosen scenario to the headset removal	intraoperative (from T0 = the patient puts on the headset and starts the initially chosen scenario until Tend = the patient takes off the headset, about 45 minutes - depending on the person and the surgery)
Time spent on each scenario and the order in which they were presented	Compare the total duration in minutes the patient wore the headset depending on the type of scenario chosen, and the order in which they were presented	intraoperative (from T0 = the patient starts the first scenario until Tend = he asks to change the scenario) - for each scenario, about 45 minutes - depending on the person and the surgery
Incidence of adverse effects	The incidence of adverse effects such as cybersickness, as reported by the patient	intraoperative (from T0 = the patient puts on the headset until Tend = the patient takes off the headset, about 45 minutes - depending on the surgery)
Patient's satisfaction	The satisfaction, ease to use the VR and main complaints of the participant, assessed through interviews using semi-standardized questions (17 open questions during a discussion, transcribe verbatim, to make a qualitative analysis)	postoperative (from T0 = the surgery ends until Tend = the semi-structured questionnaire is over, about 2 hours)

Participation Assistant

Eligibility Criteria

Eligible Ages

Older Adult

Minimum Age

65 Years

Eligible Sexes

All

Fully consented patients over 65 years old
Undergoing elective surgery that requires spinal anesthesia.

Hearing or visual impairment
History of epilepsy, seizure, or severe dizziness
Severe mental impairment
Recent eye or facial surgery or wounds
Inability to use their hands

Ciusss de L'Est de l'Île de Montréal

Study Responsible Party

Pascal Laferrière-Langlois, Principal Investigator, MD, MSc, FRQS, Assistant Professor, Principal Investigator, Anesthesiologist, Ciusss de L'Est de l'Île de Montréal

Study Central Contact

Contact: Pascal Laferrière-Langlois, +1-819-432-5847, [email protected]

Contact: Nadia Godin, 514-252-3400, [email protected]

1 Study Locations in 1 Countries

Canada

Quebec

Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal, Montreal East, Quebec, H1T2M4, Canada

Seniors' Intraoperative Management Under Locoregional Anesthesia Integrating Virtual Reality (SILVR) 55 Senior-Focused Virtual

Inclusion Criteria

Exclusion Criteria