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

Not Applicable

Recruiting

• Conditions: Medical Device; Local Anesthesia; Pain; Virtual Reality
• Interventions: Device: Virtual reality application

• Registration Number: NCT06346132
• Lead Sponsor: Schlotterbeck Hervé

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-28
• Study Start: 2024-03-29
• Study First Posted: 2024-04-03
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Virtual reality application	In this group, virtual reality will be added to usual care

Primary Outcome Measures

Name	Time	Method
Global pain intensity experienced during the procedure.	At the end of surgery	Global pain intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).

Secondary Outcome Measures

Name	Time	Method
Need for supplementary sedation and/or analgesia during the procedure.	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.
Total dose of local anaesthetic used during the procedure.	At the end of surgery	Total dose of local anaesthetic used during the procedure (total dose in mg).
Change in anesthetic strategy during procedure.	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).
Global anxiety intensity experienced during the procedure.	At the end of surgery	Global anxiety intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).
Patient's perceived procedure duration.	At the end of surgery	Patient's perceived procedure duration compared to effective procedure duration.
Incidence of hypotensive or hypoxic events during procedure.	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.
Interruption of virtual reality experience during the procedure.	At the end of surgery	If the patient choose to remove the virtual reality headset and interrupt the virtual reality experience during the procedure.
Patient's comfort during the procedure assessed by the surgeon and cardiologist.	At the end of surgery	Patient's comfort during the procedure assessed by the surgeon and cardiologist using the Numeric Rating Scale (NRS).
Maximal systolic arterial blood pressure.	At the end of surgery	Maximal systolic arterial blood pressure recorded during the procedure.
Incidence of motion sickness during the virtual reality experience.	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)
Intra- and post-procedure complications.	At patient discharge (or at a maximum of 4 hours after the end of surgery)	Registration of any complication during and after the procedure.
Overall patient's comfort and satisfaction experienced during 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 assessed with Likert's scale (5 points).

Trial Locations

Locations (1)

Istituto CardioCentro; 🇨🇭 Lugano, Ticino, Switzerland