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Recruiting NCT07450456

Effect of Virtual Reality on the Need of Premedication Before Surgery

No phase Interventional Anxiety Premedication Surgery Virtual Reality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality.
Who it may be relevant to
Registry conditions: Anxiety, Premedication, Surgery, Virtual Reality. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Virtual Reality Immersion on the Need of Pharmacological Premedication Before Cardiac Surgery

Overview

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.

Interventions

  • Device Virtual Reality
    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.

Primary outcome measures

  • Proportion of patients requiring pharmacological premedication after Virtual Reality (VR) intervention [Time frame: Up to the initiation of pre-oxygenation (same day)]
Secondary outcome measures (12)
  • Richmond Agitation Sedation Score (RAAS) [Time frame: Prior to initiation of pre-oxygenation (intraoperative period, same day)]
  • Evaluation of Pa02 and PaC02 in theater [Time frame: Immediately after arterial line insertion and prior to initiation of pre-oxygenation (same day)]
  • External evaluation of patient's comfort [Time frame: At end of induction, after airway securement (same day)]
  • Post-operative qualitative survey [Time frame: From 4 hours after patient's extubation up to 72 hours after patient's extubation]
  • Compliance with the VR intervention [Time frame: From the beginning of the intervention up to the end of the intervention (planned duration of the intervention: 20 minutes)]
  • Post-operative evaluation of patient's satisfaction regarding pre-operative period [Time frame: From 4 hours after patient's extubation up to 72 hours after patient's extubation]
  • Incidence of cyberslckness [Time frame: From the beginning of the VR intervention up to 15 minutes after the end of the VR intervention]
  • Incidence of secondary effects linked to the use of anxiolytic premedication [Time frame: From administration of anxiolytic medication until initiation of pre-oxygenation (same day)]
  • Time to Administration of Anxiolytic Premedication [Time frame: Time interval (in minutes) between completion of the VR intervention and administration of anxiolytic premedication, including rescue premedication if applicable.]
  • Change in patient's anxiety over time using Visual Analogue Scale for anxiety scale (VASA) [Time frame: From immediately before VR session to operating room entry (same day)]
  • Change in patient's anxiety over time using Amsterdam Preoperative Anxiety and Information Scale (APAIS) [Time frame: From immediately before VR session to operating room entry (same day)]
  • Change in blood pressure over time [Time frame: From immediately before VR session to operating room entry (same day)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Switzerland · 1 center
  • Istituto Cardiocentro — Lugano

Identifiers

NCT: NCT07450456 · ID 2025-01864

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗