Virtual RealityNCT06346132
Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.
A study testing Virtual reality application in people with Virtual Reality and Medical Device, run by Schlotterbeck Hervé at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virtual Reality, Medical Device, Local Anesthesia
- What is being tested?
- Virtual reality application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Communication limitations,
- Surgical procedure planned in sedation or narcosis,
- Severe sensorial deficits (visual, auditory),
- Claustrophobia,
- Known motion sickness,
- Patient isolated or with contact precautions,
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Istituto CardioCentro
Lugano, Canton Ticino, 6900
Herve Schlotterbeck, MD, +41918115189, herve.schlotterbeck@eoc.ch
About this study
Official title: Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation: a Randomized, Controlled 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.
- Conditions
- Virtual Reality, Medical Device, Local Anesthesia, Pain
- Being tested
- Virtual reality application
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality applicationDevice
In this group, virtual reality will be added to usual care
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | In this group, virtual reality will be added to usual care Receives: Device: Virtual reality application |
| Standard Group | No intervention | In this group, no extra intervention will be added to usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global pain intensity experienced during the procedure.
Global pain intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).
Measured: At the end of surgery
Secondary outcomes (12)
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.
Measured: At the end of surgery
Global anxiety intensity experienced during the procedure.
Global anxiety intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).
Measured: At the end of surgery
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).
Measured: At the end of surgery
Incidence of motion sickness during the virtual reality experience.
Incidence of motion sickness during the virtual reality experience (for example nausea)
Measured: At patient discharge (or at a maximum of 4 hours after the end of surgery)
Patient's perceived procedure duration.
Patient's perceived procedure duration compared to effective procedure duration.
Measured: At the end of surgery
Maximal systolic arterial blood pressure.
Maximal systolic arterial blood pressure recorded during the procedure.
Measured: At the end of surgery
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.
Measured: At the end of surgery
Total dose of local anaesthetic used during the procedure.
Total dose of local anaesthetic used during the procedure (total dose in mg).
Measured: At the end of surgery
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).
Measured: At the end of surgery
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.
Measured: At the end of surgery
Intra- and post-procedure complications.
Registration of any complication during and after the procedure.
Measured: 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.
Overall patient's comfort and satisfaction experienced during the procedure assessed with Likert's scale (5 points).
Measured: At patient discharge (or at a maximum of 4 hours after the end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start29 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schlotterbeck Hervé
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Schlotterbeck Hervé, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346132
- Sponsor's protocol ID
- 2024-00043 CE 4516
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation: a Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT06346132
- Acronym / sponsor ID
- 2024-00043 CE 4516
- Conditions
- Virtual Reality, Medical Device, Local Anesthesia, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Schlotterbeck HervéUniversity, hospital or other
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Virtual reality applicationIn this group, virtual reality will be added to usual care |
| Standard Group | No intervention | –In this group, no extra intervention will be added to usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Communication limitations,
- Surgical procedure planned in sedation or narcosis,
- Severe sensorial deficits (visual, auditory),
- Claustrophobia,
- Known motion sickness,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality applicationIn this group, virtual reality will be added to usual care | Device | Experimental Group |
Primary outcome
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).
12 secondary outcomes
Need for supplementary sedation and/or analgesia during the procedure.
Time frame: At the end of surgery
Global anxiety intensity experienced during the procedure.
Time frame: At the end of surgery
Patient's comfort during the procedure assessed by the surgeon and cardiologist.
Time frame: At the end of surgery
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)
Patient's perceived procedure duration.
Time frame: At the end of surgery
Maximal systolic arterial blood pressure.
Time frame: At the end of surgery
Incidence of hypotensive or hypoxic events during procedure.
Time frame: At the end of surgery
Total dose of local anaesthetic used during the procedure.
Time frame: At the end of surgery
Change in anesthetic strategy during procedure.
Time frame: At the end of surgery
Interruption of virtual reality experience during the procedure.
Time frame: At the end of surgery
Intra- and post-procedure complications.
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.
Time frame: At patient discharge (or at a maximum of 4 hours after the end of surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality application in people with Virtual Reality and Medical Device, run by Schlotterbeck Hervé at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Herve Schlotterbeck, MD (+41918115189, herve.schlotterbeck@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global pain intensity experienced during the procedure. (time frame: At the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.