Clinical trial NCT06522711: Virtual Reality for Anxiolysis and Pharmacological Sparing
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Virtual Reality
Propofol
Keywords: Virtual reality
Anxiety
Patient-controlled sedation
Pain
Propofol
Breast surgery
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
Collaborators: name: Paperplane Therapeutics
First posted: 2024-07-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Propofol self-administration
timeFrame: Between 1 hour and 3 hours
Secondary outcomes:
measure: Preoperative anxiety
timeFrame: Up to 1 hour
measure: Remifentanil administration
timeFrame: Between 1 hour and 3 hours
measure: Ketamine administration
timeFrame: Between 1 hour and 3 hours
measure: Adverse events
timeFrame: Between 1 hour and 3 hours
measure: Scenario switches
timeFrame: Between 1 hour and 3 hours
measure: Virtual reality usage
timeFrame: Between 1 hour and 3 hours
measure: Virtual reality usage per first scenario
timeFrame: Between 1 hour and 3 hours
measure: Virtual reality headset removal
timeFrame: Between 1 hour and 3 hours
measure: Post-Anesthesia Care Unit stay
timeFrame: Between 30 minutes and 2 hours
measure: Enthusiasm at the idea of using virtual reality
timeFrame: Up to 1 hour
measure: Ease of use
timeFrame: Between 30 minutes and 2 hours
measure: Enjoyment of the first scenario chosen
timeFrame: Between 30 minutes and 2 hours
measure: Overall satisfaction
timeFrame: Between 30 minutes and 2 hours
measure: NOL index readings
timeFrame: Between 1 hour and 3 hours
Other outcomes:
Locations:
city: Montréal-Est
country: Canada
facility: Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal
state: Quebec
Study officials:
affiliation: Ciusss de L'Est de l'Île de Montréal
name: Pascal Laferriere-Langlois, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.