Implementing Virtual Reality in the Operating Room

NCT06333639 | Completed

• 1 other identifier: 24Chirortho01
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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."

Conditions

General Surgery; Orthopedic Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

orthopaedic surgery (goup 1 control)

30 individuals installed according to the usual procedures for an orthopaedic surgery

Other: 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

Interventions

orthopaedic surgery OTHER

usual procedures for an orthopaedic surgery

orthopaedic surgery (goup 1 control)

orthopaedic surgery and fitted with a virtual reality headset OTHER

usual procedures for an orthopaedic surgery and fitted with a virtual reality headset

orthopaedic surgery and fitted with a virtual reality headset (group 2 case)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU NiICE

Nice, Alpes Maritimes, 0600, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 27, 2024
• Study Start: April 1, 2024
• Primary Completion: October 15, 2024
• Study Completion: February 4, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

FR (1)