Virtual Reality for Anxiolysis and Pharmacological Sparing

NCT06522711 | Not Yet Recruiting

• 1 other identifier: 2025-3802
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Virtual Reality; Propofol

Keywords

Virtual reality; Anxiety; Patient-controlled sedation; Pain; Propofol; Breast surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Preoperative anxiety

  Up to 1 hour

• Remifentanil administration

  Between 1 hour and 3 hours

• Ketamine administration

  Between 1 hour and 3 hours

• Adverse events

  Between 1 hour and 3 hours

• Scenario switches

  Between 1 hour and 3 hours

Study Arms (2)

Virtual reality

EXPERIMENTAL

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

Device: Virtual reality headset

Control

ACTIVE COMPARATOR

Standard of care group.

Other: Standard of care

Interventions

Virtual reality headset DEVICE

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.

Virtual reality

Standard of care OTHER

Standard of care in anesthesia with patient-controlled sedation.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Paperplane Therapeutics: collaborator

Study Sites (1)

Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal

Montreal East, Quebec, H1T2M4, Canada

Location

Related Publications (16)

• 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.

  PMID: 38269073 BACKGROUND

• Boyce L, Jordan C, Egan T, Sivaprakasam R. Can virtual reality enhance the patient experience during awake invasive procedures? A systematic review of randomized controlled trials. Pain. 2024 Apr 1;165(4):741-752. doi: 10.1097/j.pain.0000000000003086. Epub 2023 Oct 23.

  PMID: 37870233 BACKGROUND

• Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.

  PMID: 31136330 BACKGROUND

• Fuica R, Krochek C, Weissbrod R, Greenman D, Freundlich A, Gozal Y. Reduced postoperative pain in patients receiving nociception monitor guided analgesia during elective major abdominal surgery: a randomized, controlled trial. J Clin Monit Comput. 2023 Apr;37(2):481-491. doi: 10.1007/s10877-022-00906-1. Epub 2022 Aug 17.

  PMID: 35976578 BACKGROUND

• Gelinas C, Shahiri T S, Richard-Lalonde M, Laporta D, Morin JF, Boitor M, Ferland CE, Bourgault P, Richebe P. Exploration of a Multi-Parameter Technology for Pain Assessment in Postoperative Patients After Cardiac Surgery in the Intensive Care Unit: The Nociception Level Index (NOL)TM. J Pain Res. 2021 Dec 7;14:3723-3731. doi: 10.2147/JPR.S332845. eCollection 2021.

  PMID: 34908872 BACKGROUND

• Hitching R, Hoffman HG, Garcia-Palacios A, Adamson MM, Madrigal E, Alhalabi W, Alhudali A, Sampaio M, Peterson B, Fontenot MR, Mason KP. The Emerging Role of Virtual Reality as an Adjunct to Procedural Sedation and Anesthesia: A Narrative Review. J Clin Med. 2023 Jan 20;12(3):843. doi: 10.3390/jcm12030843.

  PMID: 36769490 BACKGROUND

• Huang MY, Scharf S, Chan PY. Effects of immersive virtual reality therapy on intravenous patient-controlled sedation during orthopaedic surgery under regional anesthesia: A randomized controlled trial. PLoS One. 2020 Feb 24;15(2):e0229320. doi: 10.1371/journal.pone.0229320. eCollection 2020.

  PMID: 32092098 BACKGROUND

• Kreienbuhl L, Elia N, Pfeil-Beun E, Walder B, Tramer MR. Patient-Controlled Versus Clinician-Controlled Sedation With Propofol: Systematic Review and Meta-analysis With Trial Sequential Analyses. Anesth Analg. 2018 Oct;127(4):873-880. doi: 10.1213/ANE.0000000000003361.

  PMID: 29750696 BACKGROUND

• Kuhn AW, Yu JK, Gerull KM, Silverman RM, Aleem AW. Virtual Reality and Surgical Simulation Training for Orthopaedic Surgery Residents: A Qualitative Assessment of Trainee Perspectives. JB JS Open Access. 2024 Mar 20;9(1):e23.00142. doi: 10.2106/JBJS.OA.23.00142. eCollection 2024 Jan-Mar.

  PMID: 38511201 BACKGROUND

• Lu Y, Hao LX, Chen L, Jin Z, Gong B. Systematic review and meta-analysis of patient-controlled sedation versus intravenous sedation for colonoscopy. Int J Clin Exp Med. 2015 Nov 15;8(11):19793-803. eCollection 2015.

  PMID: 26884890 BACKGROUND

• Rudkin GE, Osborne GA, Curtis NJ. Intra-operative patient-controlled sedation. Anaesthesia. 1991 Feb;46(2):90-2. doi: 10.1111/j.1365-2044.1991.tb09345.x.

  PMID: 1872456 BACKGROUND

• Ryu S, Kitagawa T, Goto K, Okamoto A, Marukuchi R, Hara K, Ito R, Nakabayashi Y. Intraoperative Holographic Guidance Using Virtual Reality and Mixed Reality Technology During Laparoscopic Colorectal Cancer Surgery. Anticancer Res. 2022 Oct;42(10):4849-4856. doi: 10.21873/anticanres.15990.

  PMID: 36192000 BACKGROUND

• Wang Y, Guo L, Xiong X. Effects of Virtual Reality-Based Distraction of Pain, Fear, and Anxiety During Needle-Related Procedures in Children and Adolescents. Front Psychol. 2022 Apr 19;13:842847. doi: 10.3389/fpsyg.2022.842847. eCollection 2022.

  PMID: 35519646 BACKGROUND

• Yamashita Y, Aijima R, Danjo A. Clinical effects of different virtual reality presentation content on anxiety and pain: a randomized controlled trial. Sci Rep. 2023 Nov 22;13(1):20487. doi: 10.1038/s41598-023-47764-8.

  PMID: 37993645 BACKGROUND

• Yi WS, Rouhi AD, Duffy CC, Ghanem YK, Williams NN, Dumon KR. A Systematic Review of Immersive Virtual Reality for Nontechnical Skills Training in Surgery. J Surg Educ. 2024 Jan;81(1):25-36. doi: 10.1016/j.jsurg.2023.11.012. Epub 2023 Nov 30.

  PMID: 38036388 BACKGROUND

• Zako J, Daccache N, Burey J, Clairoux A, Morisson L, Laferriere-Langlois P. Virtual reality as a strategy for intra-operatory anxiolysis and pharmacological sparing in patients undergoing breast surgeries: The V-RAPS randomized controlled trial protocol. PLoS One. 2025 Jul 7;20(7):e0327555. doi: 10.1371/journal.pone.0327555. eCollection 2025.

  PMID: 40622954 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Pascal Laferriere-Langlois, MD, MSc

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal Laferriere-Langlois, MD, MSc

CONTACT

+1 (819) 432-5847; pascal.laferriere-langlois@umontreal.ca

Nadia NG Godin, NR

CONTACT

+1 (514) 252-3400; ngodin.hmr@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Model Details: After the participants meet all the inclusion criteria and meet no exclusion criteria, patients will then be randomized by an unbiased algorithm in a 1 for 1 ratio (one control patient for each patient in the virtual reality group). However, the chosen scenario in the virtual reality group will be a result of each patient's personal preference; the patients will also be able to switch between scenarios at will.

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)