Clinical Trial Radar

Name: Virtual Reality as a Strategy for Intra-operatory Anxiolysis and Pharmacological Sparing in Patients Undergoing Breast Surgeries : the V-RAPS Randomized Controlled Trial
Creator: Ciusss de L'Est de l'Île de Montréal
Published: 2024-07-26
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT06522711 (V-RAPS) for Virtual Reality, Propofol is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Virtual Reality for Anxiolysis and Pharmacological Sparing (V-RAPS) 100 Virtual

Not yet recruiting

Clinical Trial NCT06522711 (V-RAPS) is an interventional study for Virtual Reality, Propofol and is currently not yet recruiting. Enrollment is planned to begin on 1 September 2024 and continue until the study accrues 100 participants. Led by Ciusss de L'Est de l'Île de Montréal, this study is expected to complete by 1 September 2026. The latest data from ClinicalTrials.gov was last updated on 26 July 2024.

Brief Summary

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 an...

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 t...Show More

Official Title

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

Conditions

Virtual RealityPropofol

Publications

Boutin J, Kamoonpuri J, Faieghi R, Chung J, de Ribaupierre S, Eagleson R. Smart haptic gloves for virtual reality surgery simulation: a pilot study on external ventricular drain training. Front Robot AI. 2024 Jan 10;10:1273631. doi: 10.3389/frobt.2023.1273631. eCollection 2023.

Other Study IDs

V-RAPS
2025-3802

NCT ID Number

NCT06522711

Start Date (Actual)

2024-09-01

Last Update Posted

2024-07-26

Completion Date (Estimated)

2026-09-01

Enrollment (Estimated)

100

Study Type

Interventional

PHASE

N/A

Status

Not yet recruiting

Keywords

Virtual reality
Anxiety
Patient-controlled sedation
Pain
Propofol
Breast surgery

Primary Purpose

Supportive Care

Design Allocation

Randomized

Interventional Model

Parallel

Masking

None (Open Label)

Arms / Interventions

Participant Group/Arm

Intervention/Treatment

ExperimentalVirtual reality

Patients assigned to use a virtual reality headset during their surgery.

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 interve...Show More

Active ComparatorControl

Standard of care group.

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

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

Female

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

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.

Ciusss de L'Est de l'Île de Montréal

Paperplane Therapeutics

Study Responsible Party

Pascal Laferrière-Langlois, Principal Investigator, Clinical assistant professor, Ciusss de L'Est de l'Île de Montréal

Study Central Contact

Contact: Pascal Laferriere-Langlois, MD, MSc, +1 (819) 432-5847, [email protected]

Contact: Nadia NG Godin, NR, +1 (514) 252-3400, [email protected]

1 Study Locations in 1 Countries

Canada

Quebec

Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal, Montreal East, Quebec, H1T2M4, Canada

Pascal Laferriere-Langlois, MD, MSc, Contact, +1-819-432-5847, [email protected]

Pascal Laferriere-Langlois, MD, MSc, Principal Investigator

Virtual Reality for Anxiolysis and Pharmacological Sparing (V-RAPS) 100 Virtual

Inclusion Criteria

Exclusion Criteria