Health TrialsbyHealthPanel

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

ConditionsOrthopedic ProcedureAnesthesiaSedation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Eure-Seine

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: virtual reality groupActive comparator 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Mean age of patients

Mean age of patient in each group at baseline

Time frame
Baseline (before anesthesia consultation or at inclusion)
2

Sex distribution

Number of male and female patients in each group

Time frame
Baseline (before anesthesia consultation or at inclusion)
3

type of surgery

Distribution of types of surgery performed in each group

Time frame
Baseline (before anesthesia consultation or at inclusion)
4

ASA score distribution

Distribution of ASA physical status scores among patients in each group

Time frame
Baseline (before anesthesia consultation or at inclusion)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Eure-Seine

Lead sponsor

Source ClinicalTrials.gov
Apply now