RecruitingNot ApplicableNCT07013695

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


Sponsor

Centre Hospitalier Eure-Seine

Enrollment

164 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether virtual reality (VR) can reduce the need for sedation medications during arm or leg surgery performed under regional (local) anesthesia — where you are awake but the limb is numbed. Researchers think VR may help patients stay calm and comfortable without as many drugs. **You may be eligible if...** - You are 18 years old or older - You are scheduled for planned (non-emergency) orthopedic surgery on your arm or leg - You will be receiving a regional nerve block (local anesthesia) for your surgery **You may NOT be eligible if...** - You have psychiatric or cognitive conditions that make communication difficult - You have had premedication before arriving in the operating room - You cannot understand the study due to a language barrier or psychological issues - Your surgery is an emergency - VR equipment would interfere with the surgical or anesthetic procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVirtual reality headset

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

OTHERStandard Care (in control arm)

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


Locations(1)

Centre Hospitalier Eure-Seine

Évreux, France

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NCT07013695


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