Effect of Virtual Reality on the Need of Premedication Before Surgery

NCT07450456 | Recruiting

• 1 other identifier: ID 2025-01864
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess, on patients requesting a pharmacological premedication in the preoperative period, if virtual reality reality could reduce the request of pharmacological premedication while maintaining a good level of comfort for the patient. The aim of this study is to understand if virtual reality could reduce the need for pharmacological premedication and their associated secondary effects.

Conditions

Anxiety; Premedication; Surgery; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Proportion of patients requiring pharmacological premedication after Virtual Reality (VR) intervention

  Up to the initiation of pre-oxygenation (same day)

Secondary Outcomes (14)

• Richmond Agitation Sedation Score (RAAS)

  Prior to initiation of pre-oxygenation (intraoperative period, same day)

• Evaluation of Pa02 and PaC02 in theater

  Immediately after arterial line insertion and prior to initiation of pre-oxygenation (same day)

• External evaluation of patient's comfort

  At end of induction, after airway securement (same day)

• Post-operative qualitative survey

  From 4 hours after patient's extubation up to 72 hours after patient's extubation

• Compliance with the VR intervention

  From the beginning of the intervention up to the end of the intervention (planned duration of the intervention: 20 minutes)

Study Arms (1)

Virtual reality arm

EXPERIMENTAL

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

The study intervention will take place on the day of surgery, in the ward, once patient's pre-operative preparation has been completed. The virtual reality device will be started according to the choices made by the patient (scenario and music) for a 20 min session. During that time, the patient will be left at rest and the interactions with the patient will be limited as much as possible.

Virtual reality arm

Eligibility Criteria

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

You may qualify if:

• All patients undergoing elective surgery
• Minimal age of 18-year-old
• Able to give informed consent for the study
• Requesting pharmacological premedication in the pre-operative period.

You may not qualify if:

• Lacking capacity or ability to complete the consent form or to respond to the required obligations linked to the study protocol
• Contraindications to pharmacological premedication
• Known cognitive dysfunction, previous history of neurological/psychiatric diseases like epilepsy
• Non Italian speaking patients
• Injuries to the head/face that would prohibit wearing headsets
• Infectious skin conditions of the head/face
• Contact isolation due to bacteria and viruses
• Symptoms of vertigo or motion sickness
• Reduced visual or auditory acuity
• Pregnancy
• Claustrophobia

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

Istituto Cardiocentro

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Hervé Schlotterbeck, Medical Doctor

CONTACT

0041 91 811 51 89; herve.schlotterbeck@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: March 4, 2026
• Study Start: November 11, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)