Health TrialsbyHealthPanel

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

ConditionsVirtual RealityMedical DeviceLocal AnesthesiaPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSchlotterbeck Hervé

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Communication limitations,

Surgical procedure planned in sedation or narcosis,

Severe sensorial deficits (visual, auditory),

Claustrophobia,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual reality application

    Device

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Standard GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Global pain intensity experienced during the procedure.

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

Time frame
At the end of surgery

Secondary outcomes

1

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.

Time frame
At the end of surgery
2

Global anxiety intensity experienced during the procedure.

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

Time frame
At the end of surgery
3

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).

Time frame
At the end of surgery
4

Incidence of motion sickness during the virtual reality experience.

Incidence of motion sickness during the virtual reality experience (for example nausea)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Schlotterbeck Hervé

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Sponsor institution

Source ClinicalTrials.gov
Apply now