Virtual Reality for Reducing Sedation During Breast Surgery

(V-RAPS Trial)

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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of this treatment?

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 significantly lowered anxiety levels in patients before surgery, and another study showed it reduced the need for sedation during orthopedic surgery. ^{1 2 3 4 5}

Is virtual reality therapy safe for use in medical procedures?

Research shows that virtual reality therapy is generally safe for use in medical procedures, as it has been used to reduce pain and anxiety in cancer treatments and to lower sedation needs during orthopedic surgeries without significant safety concerns. ^{1 2 5 6 7}

How is virtual reality treatment different from other treatments for reducing sedation during breast surgery?

Virtual reality treatment is unique because it uses immersive technology to distract patients, potentially reducing the need for sedatives and minimizing sedation-related risks. Unlike traditional drug-based sedation, VR offers a non-drug approach that can enhance early recovery and shorten discharge times after surgery. ^{2 4 6 8 9}

What is the purpose of this 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.

Research Team

Pascal Laferriere-Langlois, MD, MSc

Principal Investigator

Ciusss de L'Est de l'Île de Montréal

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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) 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]

References

1. England 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of immersive virtual reality therapy on intravenous patient-controlled sedation during orthopaedic surgery under regional anesthesia: A randomized controlled trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Using Immersive Virtual Reality Distraction to Reduce Fear and Anxiety before Surgery. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. [2021]

7. United States 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. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Contemplating or Acting? Which Immersive Modes Should Be Favored in Virtual Reality During Physiotherapy for Breast Cancer Rehabilitation. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Virtual reality device to improve the tolerability of lumbar puncture. [2022]