Seniors' Intraoperative Management Under Locoregional Anesthesia Integrating Virtual Reality
NCT Number: NCT06515873
Acronym: SILVR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Virtual Reality|Spinal Anesthesia
Interventions: DEVICE: Virtual Reality Headset
Sponsor: Ciusss de L'Est de l'Île de Montréal
Sex: ALL
Age: OLDER_ADULT
Enrollment: 55
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07
Completion Date: 2025-03
Locations: Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal, Montréal-Est, Quebec, H1T2M4, Canada

Summary:
This study aims to evaluate the acceptability of intraoperative virtual reality in elderly patients under spinal anesthesia.

Primary Outcome Measures: 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: 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)