Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06346132

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Virtual Reality Local Anesthesia Medical Device Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto CardioCentro

Lugano, Canton Ticino, 6900, Switzerland

Location status: Recruiting

Location contact

Herve Schlotterbeck, MD

CONTACT

[email protected]

+41918115189

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality application

Device

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

Primary outcomes

  1. Global pain intensity experienced during the procedure.

    Time frame: At the end of surgery

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

Secondary outcomes

  1. Need for supplementary sedation and/or analgesia during the procedure.

    Time frame: 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.

  2. Global anxiety intensity experienced during the procedure.

    Time frame: At the end of surgery

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

  3. Patient's comfort during the procedure assessed by the surgeon and cardiologist.

    Time frame: At the end of surgery

    Patient's comfort during the procedure assessed by the surgeon and cardiologist using the Numeric Rating Scale (NRS).

  4. Incidence of motion sickness during the virtual reality experience.

    Time frame: 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)

  5. Patient's perceived procedure duration.

    Time frame: At the end of surgery

    Patient's perceived procedure duration compared to effective procedure duration.

  6. Maximal systolic arterial blood pressure.

    Time frame: At the end of surgery

    Maximal systolic arterial blood pressure recorded during the procedure.

  7. Incidence of hypotensive or hypoxic events during procedure.

    Time frame: 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.

  8. Total dose of local anaesthetic used during the procedure.

    Time frame: At the end of surgery

    Total dose of local anaesthetic used during the procedure (total dose in mg).

  9. Change in anesthetic strategy during procedure.

    Time frame: 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).

  10. Interruption of virtual reality experience during the procedure.

    Time frame: At the end of surgery

    If the patient choose to remove the virtual reality headset and interrupt the virtual reality experience during the procedure.

  11. Intra- and post-procedure complications.

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

    Registration of any complication during and after the procedure.

  12. Overall patient's comfort and satisfaction experienced during the procedure.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Herve Schlotterbeck, MD

CONTACT

[email protected]

+41918115189

Sponsors and collaborators

Lead sponsor

Schlotterbeck Hervé

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.