AnxietyCIEDNCT07250282
Impact of Virtual Reality on Anxiety and Pain During Implantation of Cardiac Implantable Electronic Devices (CIED)
A study testing Virtual reality headset in people with Anxiety and Pain, run by Muhammed Kurt at 1 site in Germany.
Trial summary
Purpose: This study aimed to evaluate whether virtual reality technology positively affects patients' pain and anxiety throughout the entire procedure of implantation of cardiac pacemakers, defibrillators, or cardiac resynchronisation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Virtual reality headset
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years
- Indication for implantation of a cardiac pacemaker, ICD, or CRT device due to one of the following:
- Complete heart block (AV block III°)
- Symptomatic bradycardia due to sinus node dysfunction
- Tachy-brady syndrome
- Atrial fibrillation with slow ventricular rate
Show all 12Show fewer
- Symptomatic bradycardia due to AV block II° type Mobitz
- Secondary prevention of sudden cardiac death due to ventricular tachycardia
- Primary prevention in patients with heart failure with reduced ejection fraction
- Primary prevention in patients with heart failure with reduced ejection fraction and complete left bundle branch block
- "Pace and ablate" strategy for therapy-resistant persistent atrial fibrillation
- Need to Upgrade to CRT-P due to a high percentage of right ventricular pacing
Who cannot join
- Significant language barrier preventing consent or cooperation
- severe panic disorder or claustrophobia
Trial locations and contacts
1 site in 1 country.
Germany1 site
West german heart and vascular center, University hospital Essen,
Essen, North Rhine-Westphalia, 45147
About this study
Official title: Impact of Virtual Reality on Patients' Anxiety and Pain During Implantation of Cardiac Pacemakers, Implantable Cardioverter-defibrillators, or Cardiac Resynchronization Therapy: a Randomized Controlled Study
Purpose:
This study aimed to evaluate whether virtual reality technology positively affects patients' pain and anxiety throughout the entire procedure of implantation of cardiac pacemakers, defibrillators, or cardiac resynchronisation therapy.
Read the detailed description
Methods:
From January 2024 to Mai 2025, 111 Patients undergoing implantation of cardiac single-chamber or dual-chamber pacemakers or defibrillators and cardiac resynchronisation therapy were randomized to either a control group (n=55) or an intervention group (n=56). The control group received standard preoperative care using local anaesthesia and on-demand conscious sedation. A virtual reality headset was used in the intervention group in addition to the standard care intraoperatively. The State-Trait Anxiety Inventory-State (STAI-S) questionnaire was filled out by patients preoperative and immediate postoperative to best determine their perioperative state anxiety.
- Being tested
- Virtual reality headset
- Keywords
- CIED, Pacemaker, Virtual reality, ICD, CRT
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetOther
A virtual reality headset was used during the study with the purpose of distracting the patients from painful and stressful stimuli in the operation room to decrease their anxiety and pain perception
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The patients in control arm received the standard preoperative care using local anesthesia and on-demand conscious sedation |
| intervention group | Experimental | The patients in intervention arm received a virtual reality headset in addition to the standard care Receives: Other: Virtual reality headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative baseline to immediate postoperative anxiety change using State-Trait Anxiety Inventory-State (STAI-S) questionnaire score (Score range between 20 - 80, higher score means greater state anxiety)
The perioperative anxiety change of patients defined as reduction in STAI-S anxiety scores from preoperative to immediate postoperative was compared between the groups as the primary endpoint of the study
Measured: From enrolment to immediate postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Jan 2024
- Primary completion1 May 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammed Kurt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammed Kurt, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250282
- Sponsor's protocol ID
- 23-11442-BO
- Acronym
- CIED
- Status last verified
- May 2026
- First submitted
- 17 Nov 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Virtual Reality on Patients' Anxiety and Pain During Implantation of Cardiac Pacemakers, Implantable Cardioverter-defibrillators, or Cardiac Resynchronization Therapy: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07250282
- Acronym / sponsor ID
- CIED / 23-11442-BO
- Keywords
- CIED, Pacemaker, Virtual reality, ICD, CRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Muhammed KurtUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 26 Nov 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.
Purpose:
This study aimed to evaluate whether virtual reality technology positively affects patients' pain and anxiety throughout the entire procedure of implantation of cardiac pacemakers, defibrillators, or cardiac resynchronisation therapy.
Detailed description
Methods:
From January 2024 to Mai 2025, 111 Patients undergoing implantation of cardiac single-chamber or dual-chamber pacemakers or defibrillators and cardiac resynchronisation therapy were randomized to either a control group (n=55) or an intervention group (n=56). The control group received standard preoperative care using local anaesthesia and on-demand conscious sedation. A virtual reality headset was used in the intervention group in addition to the standard care intraoperatively. The State-Trait Anxiety Inventory-State (STAI-S) questionnaire was filled out by patients preoperative and immediate postoperative to best determine their perioperative state anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The patients in control arm received the standard preoperative care using local anesthesia and on-demand conscious sedation |
| intervention group | Experimental | Other: Virtual reality headsetThe patients in intervention arm received a virtual reality headset in addition to the standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- Indication for implantation of a cardiac pacemaker, ICD, or CRT device due to one of the following:
- Complete heart block (AV block III°)
- Symptomatic bradycardia due to sinus node dysfunction
- Tachy-brady syndrome
Key exclusion criteria (2 listed)
- Significant language barrier preventing consent or cooperation
- severe panic disorder or claustrophobia
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 headsetA virtual reality headset was used during the study with the purpose of distracting the patients from painful and stressful stimuli in the operation room to decrease their anxiety and pain perception | Other | intervention group |
Primary outcome
Preoperative baseline to immediate postoperative anxiety change using State-Trait Anxiety Inventory-State (STAI-S) questionnaire score (Score range between 20 - 80, higher score means greater state anxiety)
Time frame: From enrolment to immediate postoperative
The perioperative anxiety change of patients defined as reduction in STAI-S anxiety scores from preoperative to immediate postoperative was compared between the groups as the primary endpoint of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 headset in people with Anxiety and Pain, run by Muhammed Kurt at 1 site in Germany.
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 12 inclusion and 2 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: finished, as of the sponsor's last update on 3 Jun 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative baseline to immediate postoperative anxiety change using State-Trait Anxiety Inventory-State (STAI-S) questionnaire score (Score range between 20 - 80, higher score means greater state anxiety) (time frame: From enrolment to immediate postoperative). 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 3 Jun 2026.