Seniors' Intraoperative Management Under Locoregional Anesthesia Integrating Virtual Reality

Not Applicable

Not yet recruiting

• Conditions: Virtual Reality; Spinal Anesthesia
• Interventions: Device: Virtual Reality Headset

• Registration Number: NCT06515873
• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal

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 patient's 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 l'Est de l'Ile de Montreal (CEMTL), University of Montreal, Montreal, Quebec, Canada

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
a group of 55 patients	Virtual Reality Headset	-

Primary Outcome Measures

Name	Time	Method
Patient's tolerance to headset	Intraoperative (from T0 = the patient puts on the headset until Tend = 30 minutes after T0)	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

Secondary Outcome Measures

Name	Time	Method
Total of time before the patient's 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)	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.
Incidence of adverse effects	intraoperative (from T0 = the patient puts on the headset until Tend = the patient takes off the headset, about 45 minutes - depending on the surgery)	The incidence of adverse effects such as cybersickness, as reported by the patient
Anxiety before the surgery	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)	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).
Total of time during which the patient wears the VR headset during surgery.	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)	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
Time spent on each scenario 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	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
Patient's satisfaction	postoperative (from T0 = the surgery ends until Tend = the semi-structured questionnaire is over, about 2 hours)	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)

Trial Locations

Locations (1)

Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal; 🇨🇦 Montréal-Est, Quebec, Canada