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

NCT07013695 | Recruiting

• 1 other identifier: 2022-A00055-38
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Procedure; Anesthesia; Sedation

Outcome Measures

Primary Outcomes (1)

• 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.

  Intraoperative period (from arrival in the operating room to the end of surgery)

Secondary Outcomes (4)

• Mean age of patients

  Baseline (before anesthesia consultation or at inclusion)

• Sex distribution

  Baseline (before anesthesia consultation or at inclusion)

• type of surgery

  Baseline (before anesthesia consultation or at inclusion)

• ASA score distribution

  Baseline (before anesthesia consultation or at inclusion)

Study Arms (2)

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.

Device: Virtual reality headset

Control Group

PLACEBO COMPARATOR

Participants in this group receive standard anesthetic and surgical care without the use of virtual reality.

Other: Standard Care (in control arm)

Interventions

Virtual reality headset DEVICE

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

virtual reality group

Standard Care (in control arm) OTHER

Participants in this group receive standard anesthetic and surgical care without the use of virtual reality

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Eure-Seine: lead

Study Sites (1)

Centre Hospitalier Eure-Seine

Évreux, 27000, France

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jean-Baptiste HARDY

  Centre Hospitalier Eure-Seine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lydia BEN BEKKOU

CONTACT

02 32 33 86 75; arc2.circe@ch-eureseine.fr

Dihia AIDENE

CONTACT

02 32 33 86 75; arc.circe@ch-eureseine.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 10, 2025
• Study Start: July 18, 2024
• Primary Completion: July 17, 2025
• Study Completion: July 19, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)