Virtual Reality for Reducing Sedation During Breast Surgery

(V-RAPS Trial)

Not yet recruiting at 1 trial location

Overseen By Pascal Laferriere-Langlois, MD, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Disqualifiers: Epilepsy, Severe dizziness, Mental impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR Therapy) can reduce the need for sedatives during breast surgery. Using a virtual reality headset, patients might require less propofol, a common sedative, while awake during the procedure. Participants will be divided into two groups: one using virtual reality and the other receiving standard care. This trial suits women undergoing elective breast surgery with a specific type of anesthesia and without conditions such as hearing or visual impairments, seizures, or recent eye or facial surgeries. As an unphased trial, this study offers patients a unique opportunity to explore innovative approaches to surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual reality device is safe for reducing sedation during breast surgery?

Research shows that virtual reality (VR) is generally safe and easy to use. Studies have found that VR can reduce anxiety and the need for extra medication in surgical patients. In these studies, patients did not report any serious side effects from using VR.

Some individuals might experience mild discomfort, such as dizziness or nausea, but these effects are usually temporary and resolve on their own. Since VR is not a drug, it avoids risks associated with medications, like allergic reactions or interactions with other drugs.

Overall, evidence suggests that VR is a safe option for reducing the need for extra medication during surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality during breast surgery because it offers a non-drug alternative to reduce sedation. Typically, patients rely on medications to stay calm and pain-free during surgery, which can have side effects. Virtual reality distracts patients by immersing them in a different environment, potentially lowering the need for heavy sedation. This approach could lead to faster recovery times and fewer medication-related complications, making the surgical experience safer and more comfortable.

What evidence suggests that virtual reality is effective for reducing sedation during breast surgery?

Research has shown that virtual reality (VR), which participants in this trial may use, can reduce the need for sedation in surgical patients. For example, one study found that patients using VR during breast surgery required less IV sedation. This suggests that VR might help patients feel more relaxed, reducing the need for calming drugs. By decreasing sedation requirements, VR could also speed up recovery after surgery. Overall, these findings suggest that VR has the potential to make surgery less stressful and more comfortable. ^{1 2 3 4 5}

Who Is on the Research Team?

Pascal Laferriere-Langlois, MD, MSc

Principal Investigator

Ciusss de L'Est de l'Île de Montréal

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a woman over 18 and have agreed to participate.

I am having breast surgery with local anesthesia.

Exclusion Criteria

I have a hearing or visual impairment.

I cannot use a VR hand controller.

Severe mental impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo breast surgery with either standard care or virtual reality intervention to assess propofol requirements

1 day

1 visit (in-person)

Post-Anesthesia Care

Participants are monitored in the Post-Anesthesia Care Unit (PACU) for recovery and adverse events

30 minutes to 2 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of secondary outcomes like patient satisfaction and adverse events

1-3 hours

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview

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.

How Is the Trial Designed?

Group I: Virtual reality Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

Standard of care group.

Virtual Reality is already approved in United States for the following indications:

Approved in United States as Virtual Reality Therapy for:

• Functional Dyspepsia
• Irritable Bowel Syndrome (IBS)
• Gastroparesis

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Paperplane Therapeutics

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

A systematic review of nine studies on the use of immersive virtual reality (VR) for pain and anxiety management in cancer patients showed a trend towards improvement, but only two studies demonstrated statistically significant results.

The current evidence is inconclusive due to methodological limitations and small sample sizes, highlighting the need for further research to better understand the effectiveness of VR in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. Chow, H., Hon, J., Chua, W., et al.[2021]

Virtual reality (VR) significantly enhances emotional well-being in women with breast cancer by increasing positive emotions and reducing anxiety during physiotherapy sessions, regardless of the immersion method used.

Participatory VR was found to create a stronger sense of presence compared to contemplative VR, suggesting that the level of patient involvement in the virtual experience can impact emotional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemplating or Acting? Which Immersive Modes Should Be Favored in Virtual Reality During Physiotherapy for Breast Cancer Rehabilitation. Buche, H., Michel, A., Piccoli, C., et al.[2022]

In a study involving 90 breast cancer patients, both virtual reality (VR) and music therapy (MT) were found to effectively reduce psychological distress during chemotherapy, improving mood and alleviating anxiety.

VR was shown to be more effective than MT in specifically reducing anxiety, depression, and fatigue, highlighting its potential as a powerful tool for enhancing treatment tolerance and quality of life in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality and music therapy as distraction interventions to alleviate anxiety and improve mood states in breast cancer patients during chemotherapy. Chirico, A., Maiorano, P., Indovina, P., et al.[2021]

Virtual reality (VR) therapy has shown potential to improve clinical outcomes, such as reduced pain and anxiety, in adult patients undergoing surgical procedures, based on a review of 18 studies.

Factors like patient comfort and healthcare worker concerns about cost-effectiveness and infection control influence the acceptability and feasibility of VR therapy in acute care settings, indicating a need for further research to solidify its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions and the outcome measures of adult patients in acute care settings undergoing surgical procedures: An integrative review. Wang, S., Lim, SH., Aloweni, FBAB.[2022]

A systematic review of 11 randomized controlled trials involving 892 adult patients found that virtual reality (VR) interventions significantly reduce preoperative anxiety, with VR exposure being particularly effective.

In addition to lowering anxiety, VR interventions also effectively reduced heart rate and blood pressure compared to traditional methods, although they did not significantly impact respiration rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. Gao, Y., Wang, N., Liu, N.[2023]

In a randomized controlled trial involving 20 first-time sternotomy patients, immersive virtual reality (VR) treatment significantly reduced anxiety levels compared to a tablet-based control, with VR users reporting feeling calmer and less tense (P<0.05).

The study demonstrates that VR is an effective nonpharmacologic method for alleviating preoperative anxiety in adults undergoing cardiac surgery, highlighting its potential utility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial. Hendricks, TM., Gutierrez, CN., Stulak, JM., et al.[2020]

The use of interactive eye-tracked virtual reality (VR) significantly reduced presurgical anxiety by 67% in a case study of a 44-year-old female patient, demonstrating its potential as a nonpharmacologic anxiolytic.

The patient reported experiencing 'no fear' during VR compared to 'strong fear' without VR, indicating that VR can effectively distract and calm patients before surgery, suggesting a promising alternative to sedatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Immersive Virtual Reality Distraction to Reduce Fear and Anxiety before Surgery. Flores, A., Hoffman, HG., Navarro-Haro, MV., et al.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12233254/

The V-RAPS randomized controlled trial protocol

This study's main objective is to determine the impact of VR on IV sedation requirements in adult patients undergoing breast surgery under paravertebral (PV) ...

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medrxiv.org

medrxiv.org/content/10.1101/2024.11.21.24317660v1.full

the V-RAPS randomized controlled trial protocol

Objectives This study's main objective is to explore the impact of VR on IV sedation requirements in adult patients undergoing breast surgery ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06522711

Virtual Reality for Anxiolysis and Pharmacological Sparing

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 ...

4.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0327555

The V-RAPS randomized controlled trial protocol | PLOS One

This study's main objective is to determine the impact of VR on IV sedation requirements in adult patients undergoing breast surgery under paravertebral (PV) ...

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withpower.com

withpower.com/trial/phase-propofol-8-2024-dfe2c

Virtual Reality for Reducing Sedation During Breast ...

Research shows that virtual reality (VR) can help reduce anxiety and the need for sedation in patients undergoing surgery. For example, a study found that VR ...