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

March 18, 2026 updated by: Schlotterbeck Hervé

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
    • Canton Ticino
      • Lugano, Canton Ticino, Switzerland, 6900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Global pain intensity experienced during the procedure.
Time Frame: At the end of surgery
Global pain intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).
At the end of surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Need for supplementary sedation and/or analgesia during the procedure.
Time Frame: At the end of surgery
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.
Time Frame: At the end of surgery
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.
Time Frame: At the end of surgery
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.
Time Frame: At patient discharge (or at a maximum of 4 hours after the end of surgery)
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.
Time Frame: At the end of surgery
Patient's perceived procedure duration compared to effective procedure duration.
At the end of surgery
Maximal systolic arterial blood pressure.
Time Frame: At the end of surgery
Maximal systolic arterial blood pressure recorded during the procedure.
At the end of surgery
Incidence of hypotensive or hypoxic events during procedure.
Time Frame: At the end of surgery
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.
Time Frame: At the end of surgery
Total dose of local anaesthetic used during the procedure (total dose in mg).
At the end of surgery
Change in anesthetic strategy during procedure.
Time Frame: At the end of surgery
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.
Time Frame: At the end of surgery
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.
Time Frame: At patient discharge (or at a maximum of 4 hours after the end of surgery)
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.
Time Frame: 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 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Schlotterbeck Hervé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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