Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

NCT06346132 | Recruiting

• 1 other identifier: 2024-00043 CE 4516
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia.

Conditions

Virtual Reality; Medical Device; Local Anesthesia; Pain

Outcome Measures

Primary Outcomes (1)

• Global pain intensity experienced during the procedure.

  Global pain intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).

  At the end of surgery

Secondary Outcomes (12)

• Need for supplementary sedation and/or analgesia during the procedure.

  At the end of surgery

• Global anxiety intensity experienced during the procedure.

  At the end of surgery

• Patient's comfort during the procedure assessed by the surgeon and cardiologist.

  At the end of surgery

• Incidence of motion sickness during the virtual reality experience.

  At patient discharge (or at a maximum of 4 hours after the end of surgery)

• Patient's perceived procedure duration.

  At the end of surgery

Study Arms (2)

Experimental Group

EXPERIMENTAL

In this group, virtual reality will be added to usual care

Device: Virtual reality application

Standard Group

NO INTERVENTION

In this group, no extra intervention will be added to usual care

Interventions

Virtual reality application DEVICE

In this group, virtual reality will be added to usual care

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Schlotterbeck Hervé: lead

Study Sites (1)

Istituto CardioCentro

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Herve Schlotterbeck, MD

CONTACT

+41918115189; herve.schlotterbeck@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 3, 2024
• Study Start: March 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CH (1)