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NCT Number: NCT06515873

Seniors' Intraoperative Management Under Locoregional Anesthesia Integrating Virtual Reality

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

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Key information

Conditions

Virtual Reality Spinal Anesthesia

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal

Montreal East, Quebec, H1T2M4, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Headset

Device

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.

Primary outcomes

  1. Patient's tolerance to headset

    Time frame: 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 outcomes

  1. Anxiety before the surgery

    Time frame: 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).

  2. Total of time before the patient's first request to interrupt the experiment

    Time frame: 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.

  3. Total of time during which the patient wears the VR headset during surgery.

    Time frame: 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

  4. Time spent on each scenario and the order in which they were presented

    Time frame: 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

  5. Incidence of adverse effects

    Time frame: 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

  6. Patient's satisfaction

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nadia Godin

CONTACT

[email protected]

514-252-3400 ext. 3193

Pascal Laferrière-Langlois

CONTACT

[email protected]

+1-819-432-5847

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Registry information

Official study 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)

Acronym: SILVR

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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