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Behavioural Intervention
Virtual Reality for Seniors Under Spinal Anesthesia (SILVR Trial)
N/A
Waitlist Available
Led By Pascal Laferrière-Langlois
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing elective surgery that requires spinal anesthesia
Be older than 65 years old
Must not have
History of epilepsy, seizure, or severe dizziness
Hearing or visual impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative (from t0 = the patient puts on the headset until tend = 30 minutes after t0)
Awards & highlights
No Placebo-Only Group
Summary
"This trial will assess how elderly patients feel about using virtual reality during surgery while under spinal anesthesia."
Who is the study for?
This trial is for patients over 65 years old who are having elective surgery with spinal anesthesia. They must be able to give consent and use their hands. It's not for those with severe mental issues, epilepsy, recent eye or facial surgeries, or hearing/vision problems.
What is being tested?
The study tests the acceptability of using a virtual reality headset during surgery in seniors under spinal anesthesia. The goal is to see if VR can improve the surgical experience for elderly patients.
What are the potential side effects?
While not explicitly stated, potential side effects may include dizziness or nausea from the VR experience, especially since participants have conditions that exclude them if prone to seizures or severe dizziness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for surgery that will use spinal anesthesia.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of epilepsy, seizures, or severe dizziness.
Select...
I have a hearing or visual impairment.
Select...
I have had recent eye or facial surgery or wounds.
Select...
I cannot use my hands.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperative (from t0 = the patient puts on the headset until tend = 30 minutes after t0)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative (from t0 = the patient puts on the headset until tend = 30 minutes after t0)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient's tolerance to headset
Secondary study objectives
Anxiety before the surgery
Incidence of adverse effects
Patient's satisfaction
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: a group of 55 patientsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual Reality Headset
2022
N/A
~500
Find a Location
Who is running the clinical trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
78 Previous Clinical Trials
6,360 Total Patients Enrolled
1 Trials studying Virtual Reality
100 Patients Enrolled for Virtual Reality
Pascal Laferrière-LangloisPrincipal InvestigatorCiusss de L'Est de l'Île de Montréal
2 Previous Clinical Trials
124 Total Patients Enrolled