Using virtual reality to reduce the need for preoperative sedative medication
Effect of Virtual Reality Immersion on the Need of Pharmacological Premedication Before Cardiac Surgery
This trial will try virtual reality to see if it reduces the need for sedative premedication in adults who request medication before elective surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano, Canton Ticino) |
| Trial ID | NCT07450456 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for elective surgery who request pharmacological premedication will be offered a virtual reality experience in the preoperative period as an alternative or adjunct to drug premedication. The trial will record whether patients still request pharmacological premedication and measure patient comfort and any side effects. Exclusion criteria include cognitive or neurological disorders, head/face injuries that prevent headset use, motion sickness or vertigo, reduced vision/hearing, pregnancy, claustrophobia, and inability to consent or speak Italian. The goal is to see whether virtual reality can lower drug use while maintaining patient comfort and reducing medication-related adverse effects.
Who should consider this trial
Good fit: Adults (18+) scheduled for elective surgery who request pharmacological premedication, can give informed consent, and can use a VR headset (including Italian speakers able to follow study procedures) are ideal candidates.
Not a fit: Patients with cognitive or neurological disorders (including epilepsy), head/face injuries or infectious skin conditions that prevent headset use, severe motion sickness or vertigo, reduced visual or auditory acuity, pregnancy, claustrophobia, contact isolation, inability to consent, or who do not speak Italian are unlikely to participate or benefit.
Why it matters
Potential benefit: If successful, this approach could lower the use of sedative premedication and their side effects while keeping patients comfortable before surgery.
How similar studies have performed: Previous research has shown that virtual reality can reduce perioperative anxiety and sometimes lower sedative or analgesic needs, though results vary by setting.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lugano, Canton Ticino
- Istituto Cardiocentro — Lugano, Canton Ticino, Switzerland (Recruiting)
Study contacts
- Study coordinator: Hervé Schlotterbeck, Medical Doctor
- Email: herve.schlotterbeck@eoc.ch
- Phone: 0041 91 811 51 89
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.