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Seniors' Intraoperative Management Under Locoregional Anesthesia Integrating Virtual Reality (SILVR)

C

Ciusss de L'Est de l'Île de Montréal

Status

Not yet enrolling

Conditions

Spinal Anesthesia
Virtual Reality

Treatments

Device: Virtual Reality Headset

Study type

Interventional

Funder types

Other

Identifiers

NCT06515873
2025-3770

Details and patient eligibility

About

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

Full 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

Enrollment

55 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

55 participants in 1 patient group

a group of 55 patients
Experimental group
Treatment:
Device: Virtual Reality Headset

Trial contacts and locations

1

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Central trial contact

Pascal Laferrière-Langlois; Nadia Godin

Data sourced from clinicaltrials.gov

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