Virtual Reality for Anxiolysis and Pharmacological Sparing (V-RAPS)

July 25, 2024 updated by: Pascal Laferrière-Langlois, Ciusss de L'Est de l'Île de Montréal

Virtual Reality as a Strategy for Intra-operatory Anxiolysis and Pharmacological Sparing in Patients Undergoing Breast Surgeries : the V-RAPS Randomized Controlled Trial

The goal of this clinical trial is to learn if virtual reality can reduce propofol requirements in adult, female patients undergoing elective breast surgery under regional anesthesia. The main question it aims to answer is:

Can virtual reality immersion reduce intra-operative propofol requirements in adult female patients undergoing elective breast surgery under regional anesthesia?

Researchers will compare time and weight-adjusted average propofol requirements in both the intervention group and the control group to see if there is a reduction in sedative usage in the group using the virtual reality device.

Participants will be randomly assigned to either a virtual reality (intervention) group or a control group.

  • The patients in the virtual reality group will have a virtual reality headset on during the surgery with a preselected scenario of their choice.
  • Both groups will have access to patient-controlled sedation under the supervision of an anesthesiologist and will be permitted to self-administer propofol boluses as needed.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Virtual reality (VR) has carved out a growing place for itself in our leisure activities, video games and even in medicine. Recent studies show that VR can reduce anxiety and pain in patients undergoing uncomfortable care (e.g. wound care, dental care, venous access). While the population most frequently investigated is pediatric, the benefits can be extended to other populations. The operating room is uncommon due to the type of procedure and the older patient profile. Yet, with the democratization of regional and neuraxial anesthesia, VR could improve the patient experience in the operating room.

The main objective of this study is to explore the impact of VR on intravenous (I.V.) sedation requirements in adult patients undergoing breast surgery under paravertebral (PV) block. The hypothesis is that VR will serve as an effective distraction in the operative context, reducing the need for pharmacology. In parallel, multiple secondary objectives will also be explored, such as the evaluation of the tolerance to the VR headset, the impact of the chosen type of scenario on the primary outcome, the incidence of adverse effects, the variation of the Nociception Level Index (NOL index) in awake patients as well as overall patient satisfaction.

This single center, open-label, randomized controlled trial will be conducted in a Canadian academic hospital. 100 patients above the age of 18 years undergoing breast surgery (mastectomy, reduction, augmentation, reconstruction, etc.) under regional anesthesia, specifically paravertebral block, will be included in this study. Patients will be randomized either to the intervention group or the control group. The intervention group will have a VR helmet and the control group a standard treatment. Both will have access to patient-controlled sedation (PCS), self-administering their own sedation under clinical observation. Patients in the VR group will be able to choose, before the procedure begins, between 3 different VR environments and will also be allowed to switch between these environments during the surgery. The primary outcome of this study will be the time-weighted dose of propofol (sedative) self-administered during the procedure. Secondary outcomes will include patient satisfaction, premature removal of VR helmet, presence of nausea, desaturation, hypotension and post-anesthesia monitoring time.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal-Est, Quebec, Canada, H1T2M4
        • Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal
        • Contact:
        • Principal Investigator:
          • Pascal Laferriere-Langlois, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Fully consented female patients above the age of 18 years;
  • Undergoing elective, awake, breast surgery performed under paravertebral block.

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 the VR hand controller.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality
Patients assigned to use a virtual reality headset during their surgery.
Device: Virtual reality headset
A brief overview of all three virtual reality scenarios will be shown in a consolidated video prior to letting the participant select the preferred scenario. The participant's choice of scenario will then be documented. Once paravertebral blocks are completed and the participants are in supine position and the surgeon is ready to disinfect, the VR headset will be applied on the face of the participants in the intervention group and the chosen scenario will be started. If at any point the patient expresses a desire to stop using VR during the surgery, we will first offer them an alternate scenario. If they reiterate their willingness to stop, with or without having experienced the new scenario, the headset will be removed for the remainder of the surgery.
Active Comparator: Control
Standard of care group.
Other: Standard of care
Standard of care in anesthesia with patient-controlled sedation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Propofol self-administration
Time Frame: Between 1 hour and 3 hours
Time-adjusted and weight-adjusted average self-administration of propofol in mcg/kg/min in female patients undergoing breast surgery under paravertebral block.
Between 1 hour and 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative anxiety
Time Frame: Up to 1 hour
Level of anxiety before the surgery evaluated by the Amsterdam Preoperative Anxiety and Information Scale.
Up to 1 hour
Remifentanil administration
Time Frame: Between 1 hour and 3 hours
Time-adjusted and weight-adjusted average administration of remifentanil in mcg/kg/min.
Between 1 hour and 3 hours
Ketamine administration
Time Frame: Between 1 hour and 3 hours
Weight-adjusted administration of ketamine in mg/kg.
Between 1 hour and 3 hours
Adverse events
Time Frame: Between 1 hour and 3 hours
The incidence of adverse events such as cybersickness, nausea, bradycardia, desaturation and hypotension.
Between 1 hour and 3 hours
Scenario switches
Time Frame: Between 1 hour and 3 hours
Percentage of patients that switched scenarios.
Between 1 hour and 3 hours
Virtual reality usage
Time Frame: Between 1 hour and 3 hours
The total time, in minutes, as well as the relative time compared to the duration of the surgery, expressed as a percentage, during which the VR headset was worn.
Between 1 hour and 3 hours
Virtual reality usage per first scenario
Time Frame: Between 1 hour and 3 hours
Total duration in minutes spent by the patient on the VR scenario chosen, and the order in which VR scenarios were presented.
Between 1 hour and 3 hours
Virtual reality headset removal
Time Frame: Between 1 hour and 3 hours
Percentage of patients that removed the headset before the end of the surgery.
Between 1 hour and 3 hours
Post-Anesthesia Care Unit stay
Time Frame: Between 30 minutes and 2 hours
The total time in minutes spent in the PACU.
Between 30 minutes and 2 hours
Enthusiasm at the idea of using virtual reality
Time Frame: Up to 1 hour
Initial enthusiasm at the idea of using a VR headset during surgery assessed on a 10 point Likert scale.
Up to 1 hour
Ease of use
Time Frame: Between 30 minutes and 2 hours
Ease of use of the virtual reality technology assessed on a 10 point Likert scale.
Between 30 minutes and 2 hours
Enjoyment of the first scenario chosen
Time Frame: Between 30 minutes and 2 hours
Enjoyment of the first scenario chosen assessed on a 10 point Likert scale.
Between 30 minutes and 2 hours
Overall satisfaction
Time Frame: Between 30 minutes and 2 hours
Overall satisfaction with the experience assessed on a 10 point Likert scale
Between 30 minutes and 2 hours
NOL index readings
Time Frame: Between 1 hour and 3 hours
NOL index readings over time per patient, assessed continuously.
Between 1 hour and 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Collaborators

Paperplane Therapeutics

Investigators

  • Principal Investigator: Pascal Laferriere-Langlois, MD, MSc, Ciusss de L'Est de l'Île de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-3802

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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