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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Baseline to perioperative anxiety change using State-Trait Anxiety Inventory-State (STAI-S) questionnaire score pre- and periprocedurally (Score range between 20 - 80, higher score means greater state anxiety)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Significant language barrier preventing consent or cooperation
- •severe panic disorder or claustrophobia
研究组 & 干预措施
Control group
The patients in control arm received the standard preoperative care using local anesthesia and on-demand conscious sedation
intervention group
The patients in intervention arm received a virtual reality headset in addition to the standard care
干预措施: Virtual reality headset (Other)
结局指标
主要结局
Baseline to perioperative anxiety change using State-Trait Anxiety Inventory-State (STAI-S) questionnaire score pre- and periprocedurally (Score range between 20 - 80, higher score means greater state anxiety)
时间窗: From enrolment to the first postoperative day
The anxiety reduction of patients from preprocedural to periprocedural state defined as reduction in STAI-S Scores pre and periprocedural was compared between the groups as the primary endpoint of the study
次要结局
未报告次要终点
研究者
Muhammed Kurt
Attending physician, Department of Cardiology and Vascular Medicine, University Hospital Essen
University Hospital, Essen