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NCT Number: NCT07013695

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

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.

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Key information

Conditions

Orthopedic Procedure Anesthesia Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Standard Care (in control arm)

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean age of patients

    Time frame: Baseline (before anesthesia consultation or at inclusion)

    Mean age of patient in each group at baseline

  2. Sex distribution

    Time frame: Baseline (before anesthesia consultation or at inclusion)

    Number of male and female patients in each group

  3. type of surgery

    Time frame: Baseline (before anesthesia consultation or at inclusion)

    Distribution of types of surgery performed in each group

  4. ASA score distribution

    Time frame: Baseline (before anesthesia consultation or at inclusion)

    Distribution of ASA physical status scores among patients in each group

Study contacts

Contact information is provided by the study sponsor or research team.

Dihia AIDENE

CONTACT

[email protected]

02 32 33 86 75

Lydia BEN BEKKOU

CONTACT

[email protected]

02 32 33 86 75

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Eure-Seine

Other

Registry information

Acronym: VIRTUALR

Important dates

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