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OpenTrials
Completed

NCT Number: NCT06333639

Implementing Virtual Reality in the Operating Room

"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."

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Key information

Conditions

General Surgery Orthopedic Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU NiICE

Nice, Alpes Maritimes, 0600, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

orthopaedic surgery

Other

usual procedures for an orthopaedic surgery

orthopaedic surgery and fitted with a virtual reality headset

Other

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

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.

    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. 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.

    Time frame: Immediate post-operative

    • 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.

  2. Evaluate the Virtual Reality device in terms of comfort when wearing the headset, visual comfort and image and scenario quality, and auditory quality

    Time frame: Immediate post-operative

    • 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: IRVABO

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 27, 2024
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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