Seniors' Intraoperative Management Under Locoregional Anesthesia Integrating Virtual Reality

NCT06515873 | Not Yet Recruiting

• 1 other identifier: 2025-3770
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the acceptability of intraoperative virtual reality in elderly patients under spinal anesthesia.

Conditions

Virtual Reality; Spinal Anesthesia

Keywords

Elderly patient; Acceptability

Outcome Measures

Primary Outcomes (1)

• Patient's tolerance to headset

  The primary endpoint is the patient's tolerance to virtual reality defined by the headset to be worn for more than or equal to 30 minutes by the participant

  Intraoperative (from T0 = the patient puts on the headset until Tend = 30 minutes after T0)

Secondary Outcomes (6)

• Anxiety before the surgery

  preoperative (from T0 = the patient arrives at the hospital the morning of the surgery until Tend = the patient enters the operating room, about 2 hours)

• Total of time before the patient's first request to interrupt the experiment

  intraoperative (from T0 = the patient puts on the headset at the beginning of the surgery until Tend = the patient first asks to interrupt the experiment during the surgery, about 45 minutes - depending on the person and the surgery)

• Total of time during which the patient wears the VR headset during surgery.

  intraoperative (from T0 = the patient puts on the headset and starts the initially chosen scenario until Tend = the patient takes off the headset, about 45 minutes - depending on the person and the surgery)

• Time spent on each scenario and the order in which they were presented

  intraoperative (from T0 = the patient starts the first scenario until Tend = he asks to change the scenario) - for each scenario, about 45 minutes - depending on the person and the surgery

• Incidence of adverse effects

  intraoperative (from T0 = the patient puts on the headset until Tend = the patient takes off the headset, about 45 minutes - depending on the surgery)

Study Arms (1)

a group of 55 patients

EXPERIMENTAL

Device: Virtual Reality Headset

Interventions

Virtual Reality Headset DEVICE

The virtual reality headset, which will display one of the 3 available scenarios, will be placed on the patient head during a surgery under spinal anesthesia.

a group of 55 patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Fully consented patients over 65 years old
• Undergoing elective surgery that requires spinal anesthesia.

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 their hands

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

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

Montreal East, Quebec, H1T2M4, Canada

Location

Related Publications (12)

• 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

• Fuchs L, Kluska A, Novak D, Kosashvili Y. The influence of early virtual reality intervention on pain, anxiety, and function following primary total knee arthroplasty. Complement Ther Clin Pract. 2022 Nov;49:101687. doi: 10.1016/j.ctcp.2022.101687. Epub 2022 Nov 5.

  PMID: 36347152 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

• Kanyilmaz T, Topuz O, Ardic FN, Alkan H, Oztekin SNS, Topuz B, Ardic F. Effectiveness of conventional versus virtual reality-based vestibular rehabilitation exercises in elderly patients with dizziness: a randomized controlled study with 6-month follow-up. Braz J Otorhinolaryngol. 2022 Nov-Dec;88 Suppl 3(Suppl 3):S41-S49. doi: 10.1016/j.bjorl.2021.08.010. Epub 2021 Oct 26.

  PMID: 34799265 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

• Roxburgh T, Li A, Guenancia C, Pernollet P, Bouleti C, Alos B, Gras M, Kerforne T, Frasca D, Le Gal F, Christiaens L, Degand B, Garcia R. Virtual Reality for Sedation During Atrial Fibrillation Ablation in Clinical Practice: Observational Study. J Med Internet Res. 2021 May 27;23(5):e26349. doi: 10.2196/26349.

  PMID: 34042589 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

• 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

Study Officials

• Pascal Laferrière-Langlois

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal Laferrière-Langlois

CONTACT

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

Nadia Godin

CONTACT

514-252-3400; ngodin.hmr@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRQS, Assistant Professor, Principal Investigator, Anesthesiologist

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 23, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)