Implementing Virtual Reality in the Operating Room (IRVABO)

Implementing Virtual Reality in the Operating Room : Patient Satisfaction During Long Orthopaedic Surgery Under Locoregional Anaesthesia

"Recently, virtual reality has become more accessible thanks to the use of smaller, more comfortable and easier-to-use devices. Its use in operating theatres is growing.

However, despite the clinical effectiveness of virtual reality in reducing pain and anxiety, there are very few feedback studies from patients on their experience of surgery and their satisfaction, especially in orthopaedics.

The aim of this study is to demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.

The visual support offered will be appropriate to the duration of the surgery, i.e. more than 1 hour."

Study Overview

• Status: Not yet recruiting
• Conditions: Orthopedic Procedures; General Surgery
• Intervention / Treatment: Other: orthopaedic surgery; Other: orthopaedic surgery and fitted with a virtual reality headset

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: GAUCI Marc-Olivier; Phone Number: +33 04 92 03 69 04; Email: gauci.mo@chu-nice.fr

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 0600
      • CHU NiICE
      • Contact: GAUCI Marc-Olivier; Phone Number: +33 04 92 03 69 04; Email: gauci.mo@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Major patients admitted for total hip or knee replacement surgery and whose anaesthetic management is by loco-regional anaesthesia

Description

Inclusion Criteria:

• Patient 18 years of age or older
• Patient admitted for total hip or knee replacement surgery.
• Patient undergoing anaesthetic management by loco-regional anaesthesia
• Affiliation to a French health insurance scheme or equivalent
• Patient who has given his non-opposition agreement

Exclusion Criteria:

• Patient with a neurological disorder (coma, dementia, confusion, photosensitive epilepsy)
• Patient with a severe psychiatric disorder
• Patients with severe deafness or visual impairment
• Language barrier
• Pregnant or breast-feeding women of childbearing age
• Refusal of patient involvement

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
orthopaedic surgery (goup 1 control); 30 individuals installed according to the usual procedures for an orthopaedic surgery	Other: orthopaedic surgery; usual procedures for an orthopaedic surgery
orthopaedic surgery and fitted with a virtual reality headset (group 2 case); 30 individuals installed according to the usual procedures for an orthopaedic surgery and fitted with a virtual reality headset	Other: orthopaedic surgery and fitted with a virtual reality headset; usual procedures for an orthopaedic surgery and fitted with a virtual reality headset

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.	Patient satisfaction with their surgical experience. This will be measured using a Likert scale, graduated from 0 to 10, with 0 being the minimum and 10 the maximum.	Immediate post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on the doses of premedication, compared with the same surgeries without headset.	1. The number and doses of Midazolam (in mg) received in the two distinct groups will make it possible to evaluate the effectiveness of virtual reality from a pharmaceutical point of view. A difference in the use of pharmaceutical therapeutics of 20% less in patients with VR is expected to be significant. If the difference is less, the doses of premedication used in the two groups will be compared in order to assess the positive impact of VR.	Immediate post-operative
Evaluate the Virtual Reality device in terms of comfort when wearing the headset, visual comfort and image and scenario quality, and auditory quality	2. VR evaluated using a Likert scale from 0 to as well as an open-ended questionnaire evaluating (isolation from noise pollution, possibility of communicating with nursing staff, quality of audio transmitted) : The comfort of wearing the helmet Visual comfort, image and scenario quality Hearing quality (isolation from noise pollution, ability to communicate with nursing staff, quality of audio transmitted)	Immediate post-operative

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 24Chirortho01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No