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Behavioural Intervention

Virtual Reality for Reducing Sedation During Breast Surgery (V-RAPS Trial)

N/A
Waitlist Available
Led By Pascal Laferriere-Langlois, MD, MSc
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, awake, breast surgery performed under paravertebral block
Be older than 18 years old
Must not have
Hearing or visual impairment
Inability to use the VR hand controller
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 30 minutes and 2 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if using virtual reality can help reduce the amount of sedative medication needed during breast surgery in adult women. Participants will be divided into two groups: one group will use a virtual

Who is the study for?
This trial is for adult female patients planning to have elective breast surgery under regional anesthesia. Participants should not have any conditions that exclude them from the study, which are not specified here.
What is being tested?
The study is testing if using a virtual reality headset during surgery can reduce the amount of propofol sedative needed. Women in one group will wear VR headsets with chosen scenarios, while others receive standard care without VR.
What are the potential side effects?
Since this trial involves standard use of propofol and virtual reality, side effects may include typical reactions to sedatives like drowsiness or nausea and potential discomfort or disorientation from VR.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having breast surgery with local anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a hearing or visual impairment.
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I cannot use a VR hand controller.
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I have a history of epilepsy, seizures, or severe dizziness.
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I have had recent eye or facial surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 30 minutes and 2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and between 30 minutes and 2 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Propofol self-administration
Secondary study objectives
Adverse events
Ease of use
Enjoyment of the first scenario chosen
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual realityExperimental Treatment1 Intervention
Patients assigned to use a virtual reality headset during their surgery.
Group II: ControlActive Control1 Intervention
Standard of care group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual reality headset
2017
N/A
~150

Find a Location

Who is running the clinical trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor
78 Previous Clinical Trials
6,315 Total Patients Enrolled
1 Trials studying Virtual Reality
55 Patients Enrolled for Virtual Reality
Paperplane TherapeuticsUNKNOWN
Pascal Laferriere-Langlois, MD, MScPrincipal InvestigatorCiusss de L'Est de l'Île de Montréal
1 Previous Clinical Trials
155 Total Patients Enrolled
~67 spots leftby Sep 2026
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