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

Schlotterbeck Hervé

Status: Enrolling

Conditions: Medical Device; Local Anesthesia; Pain; Virtual Reality

Treatments: Device: Virtual reality application

Study type: Interventional

Funder types: Other

Identifiers

NCT06346132

2024-00043 CE 4516

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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

Treatment:

Device: Virtual reality application

Standard Group

No Intervention group

Description:

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