Implementing Virtual Reality in the Operating Room

Completed

• Conditions: Orthopedic Procedures; General Surgery
• Interventions: Other: orthopaedic surgery; Other: orthopaedic surgery and fitted with a virtual reality headset

• Registration Number: NCT06333639
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

"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."

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-27
• Study Start: 2024-04-01
• Primary Completion: 2024-10-15
• Study Completion: 2025-02-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.	Immediate post-operative	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.

Secondary Outcome Measures

Name	Time	Method
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.	Immediate post-operative	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.
Evaluate the Virtual Reality device in terms of comfort when wearing the headset, visual comfort and image and scenario quality, and auditory quality	Immediate post-operative	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)

Trial Locations

Locations (1)

CHU NiICE; 🇫🇷 Nice, Alpes Maritimes, France