General SurgeryIRVABONCT06333639
Implementing Virtual Reality in the Operating Room
An observational study of General Surgery and Orthopedic Procedures, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Surgery, Orthopedic Procedures
- What is being tested?
- orthopaedic surgery and orthopaedic surgery and fitted with a virtual reality headset
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2024to 4 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major patients admitted for total hip or knee replacement surgery and whose anaesthetic management is by loco-regional anaesthesia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing Virtual Reality in the Operating Room : Patient Satisfaction During Long Orthopaedic Surgery Under Locoregional Anaesthesia
"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.
Read more
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
- Being tested
- orthopaedic surgery, orthopaedic surgery and fitted with a virtual reality headset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthopaedic surgeryOther
usual procedures for an orthopaedic surgery
orthopaedic surgery and fitted with a virtual reality headsetOther
usual procedures for an orthopaedic surgery and fitted with a virtual reality headset
| Study group | Role | What they receive |
|---|---|---|
| orthopaedic surgery (goup 1 control) | 30 individuals installed according to the usual procedures for an orthopaedic surgery Receives: 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 Receives: Other: orthopaedic surgery and fitted with a virtual reality headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
- 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.
Measured: 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
- 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)
Measured: Immediate post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Apr 2024
- Primary completion15 Oct 2024
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333639
- Sponsor's protocol ID
- 24Chirortho01
- Acronym
- IRVABO
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Virtual Reality in the Operating Room : Patient Satisfaction During Long Orthopaedic Surgery Under Locoregional Anaesthesia
- ClinicalTrials.gov ID
- NCT06333639
- Acronym / sponsor ID
- IRVABO / 24Chirortho01
- Conditions
- General Surgery, Orthopedic Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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."
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| orthopaedic surgery (goup 1 control) | – | Other: orthopaedic surgery30 individuals installed according to the usual procedures for an orthopaedic surgery |
| orthopaedic surgery and fitted with a virtual reality headset (group 2 case) | – | Other: orthopaedic surgery and fitted with a virtual reality headset30 individuals installed according to the usual procedures for an orthopaedic surgery and fitted with a virtual reality headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients admitted for total hip or knee replacement surgery and whose anaesthetic management is by loco-regional anaesthesia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orthopaedic surgeryusual procedures for an orthopaedic surgery | Other | orthopaedic surgery (goup 1 control) |
| orthopaedic surgery and fitted with a virtual reality headsetusual procedures for an orthopaedic surgery and fitted with a virtual reality headset | Other | orthopaedic surgery and fitted with a virtual reality headset (group 2 case) |
Primary outcome
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.
2 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.
Time frame: 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
Time frame: Immediate post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Surgery and Orthopedic Procedures, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.