Clinical trial NCT06515873: Seniors' Intraoperative Management Under Locoregional Anesthesia Integrating Virtual Reality
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Virtual Reality
Spinal Anesthesia
Keywords: Elderly patient
Acceptability
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 55
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Patient's tolerance to headset
timeFrame: Intraoperative (from T0 = the patient puts on the headset until Tend = 30 minutes after T0)
Secondary outcomes:
measure: Anxiety before the surgery
timeFrame: 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)
measure: Total of time before the patient's first request to interrupt the experiment
timeFrame: 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)
measure: Total of time during which the patient wears the VR headset during surgery.
timeFrame: 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)
measure: Time spent on each scenario and the order in which they were presented
timeFrame: 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
measure: Incidence of adverse effects
timeFrame: intraoperative (from T0 = the patient puts on the headset until Tend = the patient takes off the headset, about 45 minutes - depending on the surgery)
measure: Patient's satisfaction
timeFrame: postoperative (from T0 = the surgery ends until Tend = the semi-structured questionnaire is over, about 2 hours)
Other outcomes:
Locations:
city: Montréal-Est
country: Canada
facility: Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal
state: Quebec
Study officials:
affiliation: Ciusss de L'Est de l'Île de Montréal
name: Pascal Laferrière-Langlois
role: PRINCIPAL_INVESTIGATOR
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