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

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation: a Randomized, Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Local Anesthesia; Virtual Reality; Medical Device
• Intervention / Treatment: Device: Virtual reality application

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Herve Schlotterbeck, MD; Phone Number: +41918115189; Email: herve.schlotterbeck@eoc.ch

Study Locations

• Switzerland
  • Canton Ticino
    • Lugano, Canton Ticino, Switzerland, 6900
      • Recruiting
      • Istituto CardioCentro
      • Contact: Herve Schlotterbeck, MD; Phone Number: +41918115189; Email: herve.schlotterbeck@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; In this group, virtual reality will be added to usual care	Device: Virtual reality application; In this group, virtual reality will be added to usual care
No Intervention: Standard Group; In this group, no extra intervention will be added to usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for supplementary sedation and/or analgesia during the procedure.	The need for supplementary sedation and/or analgesia during the procedure will be recorded. The doses of the drugs will be recorded.	At the end of surgery
Global anxiety intensity experienced during the procedure.	Global anxiety intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).	At the end of surgery
Patient's comfort during the procedure assessed by the surgeon and cardiologist.	Patient's comfort during the procedure assessed by the surgeon and cardiologist using the Numeric Rating Scale (NRS).	At the end of surgery
Incidence of motion sickness during the virtual reality experience.	Incidence of motion sickness during the virtual reality experience (for example nausea)	At patient discharge (or at a maximum of 4 hours after the end of surgery)
Patient's perceived procedure duration.	Patient's perceived procedure duration compared to effective procedure duration.	At the end of surgery
Maximal systolic arterial blood pressure.	Maximal systolic arterial blood pressure recorded during the procedure.	At the end of surgery
Incidence of hypotensive or hypoxic events during procedure.	Incidence of hypotensive events (defined by systolic arterial blood pressure less than 90 mmhg) and/or hypoxic events (defined by oxygen saturation under 90%) during the procedure.	At the end of surgery
Total dose of local anaesthetic used during the procedure.	Total dose of local anaesthetic used during the procedure (total dose in mg).	At the end of surgery
Change in anesthetic strategy during procedure.	If a change of anesthesiologic strategy is needed during the procedure (for example, if the patient needs an unplanned general anesthesia during the procedure).	At the end of surgery
Interruption of virtual reality experience during the procedure.	If the patient choose to remove the virtual reality headset and interrupt the virtual reality experience during the procedure.	At the end of surgery
Intra- and post-procedure complications.	Registration of any complication during and after the procedure.	At patient discharge (or at a maximum of 4 hours after the end of surgery)
Overall patient's comfort and satisfaction experienced during the procedure.	Overall patient's comfort and satisfaction experienced during the procedure assessed with Likert's scale (5 points).	At patient discharge (or at a maximum of 4 hours after the end of surgery)

Collaborators and Investigators

• Sponsor: Schlotterbeck Hervé

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: 2024-00043 CE 4516

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No