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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-29

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Virtual Reality Medical Device Local Anesthesia Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Group

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

Group Type EXPERIMENTAL

Virtual reality application

Intervention Type DEVICE

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

Standard Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual reality application

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No