Anxiety, Pain
Conditions
Keywords
CIED, Pacemaker, Virtual reality, ICD, CRT
Brief 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.
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.
Interventions
OTHERVirtual reality headset
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
Sponsors
Muhammed Kurt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* Significant language barrier preventing consent or cooperation * severe panic disorder or claustrophobia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 |
Countries
Germany
Outcome results
None listed