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

Pain Clinical Trial

Official title:

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation: a Randomized, Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06346132
• Other study ID #: 2024-00043 CE 4516
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Herve Schlotterbeck, MD
• Phone: +41918115189
• Email: herve.schlotterbeck[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Local Anesthesia
• Medical Device
• Pain
• Virtual Reality

Intervention

Device:
• Virtual reality application
In this group, virtual reality will be added to usual care

Locations

Country	Name	City	State
Switzerland	Istituto CardioCentro	Lugano	Ticino

Sponsors (1)

Lead Sponsor	Collaborator
Schlotterbeck Hervé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global pain intensity experienced during the procedure.	Global pain intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).	At the end of surgery
Secondary	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.	At the end of surgery
Secondary	Global anxiety intensity experienced during the procedure.	Global anxiety intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).	At the end of surgery
Secondary	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).	At the end of surgery
Secondary	Incidence of motion sickness during the virtual reality experience.	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)
Secondary	Patient's perceived procedure duration.	Patient's perceived procedure duration compared to effective procedure duration.	At the end of surgery
Secondary	Maximal systolic arterial blood pressure.	Maximal systolic arterial blood pressure recorded during the procedure.	At the end of surgery
Secondary	Incidence of hypotensive or hypoxic events during procedure.	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
Secondary	Total dose of local anaesthetic used during the procedure.	Total dose of local anaesthetic used during the procedure (total dose in mg).	At the end of surgery
Secondary	Change in anesthetic strategy during procedure.	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
Secondary	Interruption of virtual reality experience during the procedure.	If the patient choose to remove the virtual reality headset and interrupt the virtual reality experience during the procedure.	At the end of surgery
Secondary	Intra- and post-procedure complications.	Registration of any complication during and after the procedure.	At patient discharge (or at a maximum of 4 hours after the end of surgery)
Secondary	Overall patient's comfort and satisfaction experienced during the procedure.	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)