Orthopedic ProcedureVIRTUALRNCT07013695
Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery
A study testing Virtual reality headset in people with Orthopedic Procedure and Anesthesia, run by Centre Hospitalier Eure-Seine at 1 site in France.
Trial summary
The VIRTUALR study evaluates the effect of virtual reality combined with hypnosis on anxiety in patients undergoing orthopedic surgery under regional anesthesia. Patients are randomly assigned to two groups: one group receiving virtual reality and a control group without the device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Procedure, Anesthesia, Sedation
- What is being tested?
- Virtual reality headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2024to 19 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Signed informed consent
- Patient affiliated with or benefiting from a social security system
- Patient aged 18 years or older
- Patient requiring regional anesthesia for scheduled orthopedic surgery of the upper or lower limb
Who cannot join
- Patient refusal to participate in the study
- Device interfering with the surgical or anesthetic procedure
- Premedication before arrival in the operating room
- Psychiatric or cognitive disorders, communication disorders
- Patient unable to understand the study (language barrier, psychological issues)
- Emergency surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Eure-Seine
Évreux, 27000
BEN BEKKOU Lydia, 02 32 33 86 75, arc2.circe@ch-eureseine.fr
AIDENE Dihia, 02 32 33 86 75, arc.circe@ch-eureseine.fr
About this study
The VIRTUALR study evaluates the effect of virtual reality combined with hypnosis on anxiety in patients undergoing orthopedic surgery under regional anesthesia. Patients are randomly assigned to two groups: one group receiving virtual reality and a control group without the device. Anxiety and satisfaction questionnaires are used to compare the two groups.
- Conditions
- Orthopedic Procedure, Anesthesia, Sedation
- Being tested
- Virtual reality headset, Standard Care (in control arm)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetDevice
Patients in the intervention group receive a virtual reality session with a hypnotic purpose during surgery under regional anesthesia. The device consists of a virtual reality headset providing visual and auditory immersion in a calming environment, freely chosen by the patient. The session begins before the regional anesthesia is administered and may continue throughout the entire surgical procedure
Standard Care (in control arm)Other
Participants in this group receive standard anesthetic and surgical care without the use of virtual reality
| Study group | Role | What they receive |
|---|---|---|
| virtual reality group | Active comparator | Participants in this group receive a virtual reality session with a hypnotic objective during surgery performed under regional anesthesia. The device consists of a virtual reality headset offering immersive visual and auditory content in a calming environment chosen by the participant. The session begins before the administration of regional anesthesia and may continue throughout the surgical procedure. Receives: Device: Virtual reality headset |
| Control Group | Placebo comparator | Participants in this group receive standard anesthetic and surgical care without the use of virtual reality. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of sedation use rates between the experimental group and the control group (level 0 versus ≥1).
Proportion of patients who required sedation (at level ≥1) during regional anesthesia or surgery, compared to those who did not receive sedation (level 0). Sedation levels are defined according to a standardized scale.
Measured: Intraoperative period (from arrival in the operating room to the end of surgery)
Secondary outcomes (4)
Mean age of patients
Mean age of patient in each group at baseline
Measured: Baseline (before anesthesia consultation or at inclusion)
Sex distribution
Number of male and female patients in each group
Measured: Baseline (before anesthesia consultation or at inclusion)
type of surgery
Distribution of types of surgery performed in each group
Measured: Baseline (before anesthesia consultation or at inclusion)
ASA score distribution
Distribution of ASA physical status scores among patients in each group
Measured: Baseline (before anesthesia consultation or at inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start18 Jul 2024
- Primary completion17 Jul 2025 (estimated)
- Study completion19 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic ProcedureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel-group study with two arms (virtual reality group vs. control group) comparing the effect of virtual reality on sedation use during regional anesthesia.
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Eure-Seine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste HARDY, Principal investigator, Centre Hospitalier Eure-Seine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013695
- Sponsor's protocol ID
- 2022-A00055-38
- Acronym
- VIRTUALR
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07013695
- Acronym / sponsor ID
- VIRTUALR / 2022-A00055-38
- Conditions
- Orthopedic Procedure, Anesthesia, Sedation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Centre Hospitalier Eure-SeineUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 17 Jul 2025 (estimated)
- Study completion
- 19 Jul 2025 (estimated)
- First posted
- 10 Jun 2025 (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.
The VIRTUALR study evaluates the effect of virtual reality combined with hypnosis on anxiety in patients undergoing orthopedic surgery under regional anesthesia. Patients are randomly assigned to two groups: one group receiving virtual reality and a control group without the device. Anxiety and satisfaction questionnaires are used to compare the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized parallel-group study with two arms (virtual reality group vs. control group) comparing the effect of virtual reality on sedation use during regional anesthesia.
| Arm | Type | Receives |
|---|---|---|
| virtual reality group | Active comparator | Device: Virtual reality headsetParticipants in this group receive a virtual reality session with a hypnotic objective during surgery performed under regional anesthesia. The device consists of a virtual reality headset offering immersive visual and auditory content in a calming environment chosen by the participant. The session begins before the administration of regional anesthesia and may continue throughout the surgical procedure. |
| Control Group | Placebo comparator | Other: Standard Care (in control arm)Participants in this group receive standard anesthetic and surgical care without the use of virtual reality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Patient affiliated with or benefiting from a social security system
- Patient aged 18 years or older
- Patient requiring regional anesthesia for scheduled orthopedic surgery of the upper or lower limb
Key exclusion criteria (6 listed)
- Patient refusal to participate in the study
- Device interfering with the surgical or anesthetic procedure
- Premedication before arrival in the operating room
- Psychiatric or cognitive disorders, communication disorders
- Patient unable to understand the study (language barrier, psychological issues)
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 |
|---|---|---|
| Virtual reality headsetPatients in the intervention group receive a virtual reality session with a hypnotic purpose during surgery under regional anesthesia. The device consists of a virtual reality headset providing visual and auditory immersion in a calming environment, freely chosen by the patient. The session begins before the regional anesthesia is administered and may continue throughout the entire surgical procedure | Device | virtual reality group |
| Standard Care (in control arm)Participants in this group receive standard anesthetic and surgical care without the use of virtual reality | Other | Control Group |
Primary outcome
Comparison of sedation use rates between the experimental group and the control group (level 0 versus ≥1).
Time frame: Intraoperative period (from arrival in the operating room to the end of surgery)
Proportion of patients who required sedation (at level ≥1) during regional anesthesia or surgery, compared to those who did not receive sedation (level 0). Sedation levels are defined according to a standardized scale.
4 secondary outcomes
Mean age of patients
Time frame: Baseline (before anesthesia consultation or at inclusion)
Sex distribution
Time frame: Baseline (before anesthesia consultation or at inclusion)
type of surgery
Time frame: Baseline (before anesthesia consultation or at inclusion)
ASA score distribution
Time frame: Baseline (before anesthesia consultation or at inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Jean-Baptiste HARDY principal investigator
Centre Hospitalier Eure-Seine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality headset in people with Orthopedic Procedure and Anesthesia, run by Centre Hospitalier Eure-Seine 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 4 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: looking for participants now, as of the sponsor's last update on 10 Jun 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lydia BEN BEKKOU (02 32 33 86 75, arc2.circe@ch-eureseine.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of sedation use rates between the experimental group and the control group (level 0 versus ≥1). (time frame: Intraoperative period (from arrival in the operating room to the end of surgery)). 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 Jun 2025.