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Recruiting NCT07013695

NCT07013695 Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery

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Clinical Trial Summary
NCT ID NCT07013695
Status Recruiting
Phase —
Sponsor Centre Hospitalier Eure-Seine
Condition Orthopedic Procedure
Study Type INTERVENTIONAL
Enrollment 164 participants
Start Date 2024-07-18
Primary Completion 2025-07-17

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Virtual reality headsetStandard Care (in control arm)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 164 participants in total. It began in 2024-07-18 with a primary completion date of 2025-07-17.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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. Anxiety and satisfaction questionnaires are used to compare the two groups.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Contact & Investigator

Central Contact

Lydia BEN BEKKOU

✉ arc2.circe@ch-eureseine.fr

📞 02 32 33 86 75

Principal Investigator

Jean-Baptiste HARDY

PRINCIPAL INVESTIGATOR

Centre Hospitalier Eure-Seine

Frequently Asked Questions

Who can join the NCT07013695 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Orthopedic Procedure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07013695 currently recruiting?

Yes, NCT07013695 is actively recruiting participants. Contact the research team at arc2.circe@ch-eureseine.fr for enrollment information.

Where is the NCT07013695 trial being conducted?

This trial is being conducted at Évreux, France.

Who is sponsoring the NCT07013695 clinical trial?

NCT07013695 is sponsored by Centre Hospitalier Eure-Seine. The principal investigator is Jean-Baptiste HARDY at Centre Hospitalier Eure-Seine. The trial plans to enroll 164 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: November 2026  ·  Data Methodology