A Two-center, Randomized, Controlled Trial Investigating a Newly-developed Neuromodulation Auditory System Using Binaural Beats to Optimize Patient Experience During Dysfunctional Dialysis Access Endovascular Procedures
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Overall patient experience
研究概览
简要总结
Peri-procedural stress is a common challenge in interventional radiology that can negatively impact patient tolerance and the overall procedural experience. This randomized controlled trial (RCT) was designed to evaluate the clinical impact of a non-commercially available, newly-developed structured auditory neuromodulation system, designed to optimize patient experience during endovascular procedures for dysfunctional dialysis access.
详细描述
Following an extensive development phase, a two-center RCT will be conducted at two Interventional Radiology Departments of tertiary university hospitals. Patients fulfilling the study's inclusion criteria will be randomized on a 1:1 basis to undergo endovascular procedures for dysfunctional dialysis vascular access-performed under local anaesthesia without sedation-either with the audio system (Group Sound; S) or without it (Group Control; C). The intervention is utilizing an MP3 audio system and headphones delivering binaural beats, isochronic tones, and music designed to induce relaxation by achieving the alpha brainwave state (8-12Hz). Patient experience will be evaluated via standardized self-reported questionnaires. Patient's demographical data and procedural details will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Dysfunctional vascular access (AVF or AVG) requiring endovascular treatment.
- •Balloon Angioplasty procedure
- •Stent graft procedure
- •Percutaneous declotting procedure
排除标准
- •Patient not tolerating headphones or music for any reason
- •Patients less than 18 years old
- •Patients unable to comprehend and complete the questionnaire
研究组 & 干预措施
Group Sound
Patients randomized to undergo the procedure with the audio system
干预措施: Neuromodulation auditory system (Device)
Group Control
Patients randomized to undergo the procedure without the audio system
结局指标
主要结局
Overall patient experience
时间窗: Within the first hour after the procedure
Completion of a standardized self-reported Stress-orientated questionnaire, with higher values indicating worst outcome.
次要结局
未报告次要终点
研究者
Stavros Spiliopoulos
Professor of Diagnostic and Interventional Radiology
Attikon Hospital
