Using virtual reality to improve comfort during heart device implantation
Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation: a Randomized, Controlled Trial.
NA · Ente Ospedaliero Cantonale, Bellinzona · NCT06346132
This study tests if using virtual reality can help adults feel more comfortable and less anxious during heart device implant procedures.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona (other) |
| Locations | 1 site (Lugano, Canton Ticino) |
| Trial ID | NCT06346132 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of a virtual reality experience on patient comfort during the implantation of cardiac electronic devices under local anesthesia. Patients over 18 years old who are undergoing either a new device implantation or a battery change will participate. The intervention involves the use of a virtual reality application designed to enhance the patient's experience during the procedure. The study aims to determine if this innovative approach can reduce discomfort and anxiety associated with the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 undergoing cardiac electronic device implantation or battery replacement under local anesthesia.
Not a fit: Patients with communication limitations, severe sensory deficits, or those undergoing sedation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance patient comfort and reduce anxiety during cardiac procedures.
How similar studies have performed: While the use of virtual reality in medical settings is gaining traction, this specific application in cardiac device implantation is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 year old, * Patients who signed the consent form and accepted to participate to the trial, * New cardiac electronic device implantation or cardiac electronic device battery change, * Surgical procedure planned in ambulatory care. Exclusion Criteria: * Communication limitations, * Surgical procedure planned in sedation or narcosis, * Severe sensorial deficits (visual, auditory), * Claustrophobia, * Known motion sickness, * Patient isolated or with contact precautions, * Known or anticipated psychiatric diseases, * Patient known for epilepsia, * Opened scar and or ongoing infection at the level of the face and/or eyes, * Patient evaluated non suitable for the study by the surgeon, cardiologist or anesthetist.
Where this trial is running
Lugano, Canton Ticino
- Istituto CardioCentro — Lugano, Canton Ticino, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Herve Schlotterbeck, MD
- Email: herve.schlotterbeck@eoc.ch
- Phone: +41918115189
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.
Conditions: Virtual Reality, Medical Device, Local Anesthesia, Pain