Implementing Virtual Reality in the Operating Room

NCT ID: NCT06333639

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-02-04

Brief Summary

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"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

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Conditions

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General Surgery Orthopedic Procedures

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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orthopaedic surgery (goup 1 control)

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

orthopaedic surgery

Intervention Type OTHER

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

orthopaedic surgery and fitted with a virtual reality headset

Intervention Type OTHER

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

Interventions

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orthopaedic surgery

usual procedures for an orthopaedic surgery

Intervention Type OTHER

orthopaedic surgery and fitted with a virtual reality headset

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU NiICE

Nice, Alpes Maritimes, France

Site Status

Countries

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France

Other Identifiers

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24Chirortho01

Identifier Type: -

Identifier Source: org_study_id

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