Actively Recruiting
Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation: a Randomized, Controlled Trial.
Led by Schlotterbeck Hervé · Updated on 2026-03-20
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effect of a virtual reality experience on patient comfort during the implantation of cardiac electronic devices under local anesthesia. The study focuses on how virtual reality might influence pain, anxiety, and overall comfort during this procedure. It is a randomized, controlled trial led by Schlotterbeck Hervé to better understand patient experience during such interventions. Participants will be assigned randomly to one of two groups. One group will receive usual care plus a virtual reality application during the procedure, while the other group will receive usual care alone with no additional interventions. The trial compares these approaches to assess differences in patient comfort and other related factors. During the procedure and immediately afterward, researchers will measure pain intensity, anxiety levels, need for extra sedation or analgesia, blood pressure changes, and any side effects like motion sickness. Surgeons and cardiologists will also assess patient comfort. Follow-up evaluations will occur up to four hours post-surgery, including any complications and overall satisfaction. The study duration per participant covers the procedure and short-term recovery period.
CONDITIONS
Brief Title
Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old
- Patients who signed the consent form and agreed to participate
- Patients scheduled for new cardiac electronic device implantation or battery change
- Surgical procedure planned in ambulatory care under local anesthesia
You will not qualify if you...
- Communication limitations
- Surgical procedure planned under sedation or general anesthesia
- Severe sensory deficits (visual, auditory)
- Claustrophobia
- Known motion sickness
- Patient isolated or under contact precautions
- Known or anticipated psychiatric diseases
- Patient known to have epilepsy
- Open scar or ongoing infection near face or eyes
- Patient deemed unsuitable by surgeon, cardiologist, or anesthetist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to the duration of the surgical procedure
Participants receive a cardiac electronic device implantation with or without the addition of virtual reality during the procedure.
1 procedure visit (in-person)
Trial Site Locations
Total: 1 location
1
Istituto CardioCentro
Lugano, Canton Ticino, Switzerland, 6900
Actively Recruiting
Research Team
H
Herve Schlotterbeck, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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