Implementing Virtual Reality in the Operating Room

General Surgery Clinical Trial

— IRVABO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06333639
• Other study ID #: 24Chirortho01
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: October 15, 2024

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: GAUCI Marc-Olivier
• Phone: 04 92 03 69 04
• Email: gauci.mo[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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."

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Surgery
• Orthopedic Procedures

Intervention

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

Locations

Country	Name	City	State
France	CHU NiICE	Nice	Alpes Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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