Pain, AcuteNCT07009951
Impact of Virtual Reality in Cardiac Electrophysiology
An observational study of Pain, Acute, run by University of Calabria at 1 site in Italy.
Trial summary
Pain during pacemaker or defibrillator implantation can increase patient discomfort, anxiety, and the need for deeper sedation. Using virtual reality (VR) as a non-pharmacological distraction tool may help reduce perceived pain, stabilize vital signs, and improve the overall patient experience. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2025to 31 Dec 2025
- Phase
- Observational
- 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
Study population: Patients aged ≥18 years, eligible for implantation of cardiac pacing devices, able to provide informed consent and report their level of pain.
Who may be able to join
- Age ≥ 18 years.
- Patients who are candidates for pacemaker (PM) or implantable cardioverter-defibrillator (ICD) implantation, including new devices such as leadless PM and subcutaneous ICD (S-ICD).
- Ability to provide written informed consent.
- Ability to understand the use of the VR headset and express a pain score using the NRS scale.
Who cannot join
- Severe cognitive, psychiatric or neurological disorders that impair understanding or collaboration in the study.
- Visual and/or auditory and inner ear disorders or severe vertigo that could be aggravated by VR.
- Allergies or known adverse reactions to standard sedative therapies provided for in the protocol (e.g. midazolam) if essential for the procedure.
- Inability to correctly position the VR headset (e.g. severe facial deformities, recent trauma to the craniofacial area).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
"Annunziata" Hospital
Cosenza, 87100
Antonio Curcio, Prof, +390984681889, antonio.curcio.cardio@unical.it
About this study
Official title: Acute Clinical Outcomes Following the Implementation of Virtual Reality (VR) in the Electrophysiology Laboratory
Pain during pacemaker or defibrillator implantation can increase patient discomfort, anxiety, and the need for deeper sedation. Using virtual reality (VR) as a non-pharmacological distraction tool may help reduce perceived pain, stabilize vital signs, and improve the overall patient experience. This prospective, single-center study evaluates whether adding VR to standard sedation lowers pain levels compared to sedation alone. Patients undergoing device implantation will be randomized to either group, with pain and vital signs monitored throughout the procedure. The study also explores patient satisfaction, adverse effects, and the potential of VR to support same-day discharge after minimally invasive procedures.
- Conditions
- Pain, Acute
- Being tested
- Virtual reality
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
VR headset provides an immersive environment, such as natural landscapes accompanied by relaxing music. The use of VR will begin at least five minutes before the start of the procedure to allow the patient to acclimate. The headset will remain in use throughout the entire procedure, unless complications arise (e.g., nausea or significant discomfort).
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality Group | Patients who receive a virtual reality headset that provides an immersive environment, such as natural landscapes accompanied by relaxing music. The use of VR will begin at least five minutes before the start of the procedure to allow the patient to acclimate. The headset will remain in use throughout the entire procedure, unless complications arise (e.g., nausea or significant discomfort). Receives: Device: Virtual reality | |
| Control Group (Standard Sedation) | Patients who receive standard sedation (e.g. midazolam and/or fentanyl at the operator's discretion, according to hospital protocol), in accordance with comfort and analgesia guidelines for cardiac pacing procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and discomfort
To evaluate the difference in pain perception between a group using virtual reality (VR) and a control group subjected only to standard sedation, measured using the Numeric Rating Scale (NRS). The NRS is a self-reported scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater pain and discomfort. The NRS will be recorded at the end of the procedure, referring to the pain experienced during the entire electrophysiology procedure.
Measured: during electrophysiology procedures
Systolic Blood Pressure
To compare the change in systolic blood pressure (mmHg) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
Measured: during electrophysiology procedures
Heart Rate
To compare the change in heart rate (beats per minute) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
Measured: during electrophysiology procedures
Respiratory Rate
To compare the change in respiratory rate (breaths per minute) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
Measured: during electrophysiology procedures
Oxygen Saturation
To compare the change in oxygen saturation (SpO₂, %) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
Measured: during electrophysiology procedures
Secondary outcomes (2)
Patient satisfaction
To evaluate patient satisfaction with the overall experience of the procedure. Satisfaction will be assessed using a structured questionnaire at the end of the procedure. Results will be expressed as a percentage score from 0% to 100%, where higher percentages indicate greater satisfaction. The satisfaction level will be categorized as follows:
0-20%: Very unsatisfied 21-40%: Unsatisfied 41-60%: Neither satisfied nor unsatisfied 61-79%: Satisfied 80-100%: Very satisfied
Measured: during electrophysiology procedures
Hospital stay length
To evaluate whether the use of virtual reality (VR) during electrophysiology procedures can contribute to a reduction in hospital stay, potentially allowing early discharge in some cases. The outcome will be measured as the mean number of days of hospital stay, and the difference between the VR group and the control group will be assessed.
Measured: through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Jul 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calabria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Curcio, University of Calabria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009951
- Sponsor's protocol ID
- 60/2025
- Status last verified
- Aug 2025
- First submitted
- 15 May 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Clinical Outcomes Following the Implementation of Virtual Reality (VR) in the Electrophysiology Laboratory
- ClinicalTrials.gov ID
- NCT07009951
- Acronym / sponsor ID
- 60/2025
- Conditions
- Pain, Acute
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalabriaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Jun 2025 (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.
Pain during pacemaker or defibrillator implantation can increase patient discomfort, anxiety, and the need for deeper sedation. Using virtual reality (VR) as a non-pharmacological distraction tool may help reduce perceived pain, stabilize vital signs, and improve the overall patient experience. This prospective, single-center study evaluates whether adding VR to standard sedation lowers pain levels compared to sedation alone. Patients undergoing device implantation will be randomized to either group, with pain and vital signs monitored throughout the procedure. The study also explores patient satisfaction, adverse effects, and the potential of VR to support same-day discharge after minimally invasive procedures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality Group | – | Device: Virtual realityPatients who receive a virtual reality headset that provides an immersive environment, such as natural landscapes accompanied by relaxing music. The use of VR will begin at least five minutes before the start of the procedure to allow the patient to acclimate. The headset will remain in use throughout the entire procedure, unless complications arise (e.g., nausea or significant discomfort). |
| Control Group (Standard Sedation) | – | –Patients who receive standard sedation (e.g. midazolam and/or fentanyl at the operator's discretion, according to hospital protocol), in accordance with comfort and analgesia guidelines for cardiac pacing procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥18 years, eligible for implantation of cardiac pacing devices, able to provide informed consent and report their level of pain.
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Patients who are candidates for pacemaker (PM) or implantable cardioverter-defibrillator (ICD) implantation, including new devices such as leadless PM and subcutaneous ICD (S-ICD).
- Ability to provide written informed consent.
- Ability to understand the use of the VR headset and express a pain score using the NRS scale.
Key exclusion criteria (4 listed)
- Severe cognitive, psychiatric or neurological disorders that impair understanding or collaboration in the study.
- Visual and/or auditory and inner ear disorders or severe vertigo that could be aggravated by VR.
- Allergies or known adverse reactions to standard sedative therapies provided for in the protocol (e.g. midazolam) if essential for the procedure.
- Inability to correctly position the VR headset (e.g. severe facial deformities, recent trauma to the craniofacial area).
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 realityVR headset provides an immersive environment, such as natural landscapes accompanied by relaxing music. The use of VR will begin at least five minutes before the start of the procedure to allow the patient to acclimate. The headset will remain in use throughout the entire procedure, unless complications arise (e.g., nausea or significant discomfort). | Device | Virtual reality Group |
Primary outcome
Pain and discomfort
Time frame: during electrophysiology procedures
To evaluate the difference in pain perception between a group using virtual reality (VR) and a control group subjected only to standard sedation, measured using the Numeric Rating Scale (NRS). The NRS is a self-reported scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater pain and discomfort. The NRS will be recorded at the end of the procedure, referring to the pain experienced during the entire electrophysiology procedure.
Systolic Blood Pressure
Time frame: during electrophysiology procedures
To compare the change in systolic blood pressure (mmHg) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
Heart Rate
Time frame: during electrophysiology procedures
To compare the change in heart rate (beats per minute) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
Respiratory Rate
Time frame: during electrophysiology procedures
To compare the change in respiratory rate (breaths per minute) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
Oxygen Saturation
Time frame: during electrophysiology procedures
To compare the change in oxygen saturation (SpO₂, %) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
2 secondary outcomes
Patient satisfaction
Time frame: during electrophysiology procedures
Hospital stay length
Time frame: through study completion, an average of 7 days
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 7 Aug 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Pain, Acute, run by University of Calabria at 1 site in Italy.
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 4 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 7 Aug 2025. 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 Italy. 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 Antonio Curcio, Prof. (+390984681889, antonio.curcio.cardio@unical.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and discomfort (time frame: during electrophysiology procedures). The study lists 5 primary outcomes in all. 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 7 Aug 2025.