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Seniors' Intraoperative Management Under Locoregional Anesthesia Integrating Virtual Reality

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)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06515873
Acronym
SILVR
Enrollment
55
Registered
2024-07-23
Start date
2024-07-31
Completion date
2025-03-31
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia, Virtual Reality

Keywords

Elderly patient, Acceptability

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

Interventions

DEVICEVirtual 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.

Sponsors

Ciusss de L'Est de l'Île de Montréal
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient's tolerance to headsetIntraoperative (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

MeasureTime frameDescription
Total of time before the patient's first request to interrupt the experimentintraoperative (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.
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
Anxiety before the surgerypreoperative (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).
Incidence of adverse effectsintraoperative (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
Patient's satisfactionpostoperative (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)
Time spent on each scenario and the order in which they were presentedintraoperative (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 surgeryCompare 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

Countries

Canada

Contacts

Primary ContactPascal Laferrière-Langlois
pascal.laferriere-langlois@umontreal.ca+1-819-432-5847
Backup ContactNadia Godin
ngodin.hmr@ssss.gouv.qc.ca514-252-3400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026