Virtual reality to reduce discomfort during pacemaker and defibrillator implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, randomized study at Annunziata Hospital that assigns adults undergoing pacemaker or ICD implantation to either standard sedation alone or standard sedation plus a VR headset for distraction. Pain will be measured with a numeric rating scale and vital signs will be monitored throughout the procedure, while patient satisfaction and adverse events are recorded. The trial includes modern device types such as leadless pacemakers and subcutaneous ICDs and also explores whether VR can support same-day discharge after minimally invasive procedures. Outcomes will compare pain levels, sedation needs, physiological stability, and safety between the two groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years.
* Patients who are candidates for pacemaker (PM) or implantable cardioverter-defibrillator (ICD) implantation, including new devices such as leadless PM and subcutaneous ICD (S-ICD).
* Ability to provide written informed consent.
* Ability to understand the use of the VR headset and express a pain score using the NRS scale.

Exclusion Criteria:

* Severe cognitive, psychiatric or neurological disorders that impair understanding or collaboration in the study.
* Visual and/or auditory and inner ear disorders or severe vertigo that could be aggravated by VR.
* Allergies or known adverse reactions to standard sedative therapies provided for in the protocol (e.g. midazolam) if essential for the procedure.
* Inability to correctly position the VR headset (e.g. severe facial deformities, recent trauma to the craniofacial area).

Where it's running

• "Annunziata" Hospital
  Cosenza, Italy Recruiting

Study contacts

• Study coordinator: Antonio Curcio, Prof.
• Email: antonio.curcio.cardio@unical.it
• Phone: +390984681889

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SAM aluminium splint for suspected wrist fractures

  This study will see if adding a SAM aluminium splint to usual care reduces pain for people with suspected wrist fractures who come to the emergency department.

  Recruiting Region Skane · Malmö · NCT07553000

• Combined acupressure to reduce post-thoracotomy pain and improve lung volume

  This trial will try combined acupressure on patients after thoracotomy to see if it reduces postoperative pain and helps restore lung volume.

  Recruiting Dogus Universitesi · Istanbul · NCT07411417

• Phase 1 testing of SBS-147 in healthy adults

  This study will test if SBS-147 is safe and how healthy adults' bodies handle single or repeated doses compared with a placebo.

  Recruiting Phase 1 Sparian Biosciences, Inc · Cypress, California · NCT07335913

• Butyrate and Taurine for Chronic Postoperative Pain in Adults after Cardiac Surgery

  This study tests whether taking taurine and butyrate daily can reduce long-lasting pain after cardiac surgery in adults.

  Recruiting Chinese University of Hong Kong · Hong Kong · NCT07144033

• Perioperative IV nimodipine for people undergoing open colectomy for bowel cancer

  This trial tests whether giving intravenous nimodipine around the time of open colectomy can reduce opioid use, lower pain, and speed early bowel recovery for people having surgery for bowel cancer.

  Recruiting University of Ioannina · Pátrai, Achaea · NCT07048522

• Paracetamol with ibuprofen versus paracetamol with metamizole for pain in children with acute pancreatitis

  We will test whether IV paracetamol combined with ibuprofen or IV paracetamol combined with metamizole reduces pain more effectively in children aged 3–18 with acute pancreatitis.

  Recruiting Phase 4 Medical University of Warsaw · Warsaw · NCT07024199

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.