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Clinical Trials/NCT06333639
NCT06333639
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Nice1 site in 1 country45 target enrollmentApril 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
General Surgery
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
45
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
last year

Overview

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."

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
February 4, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: 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 Outcomes

  • 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 Sites (1)

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