跳至主要内容
临床试验/NCT07467642
NCT07467642进行中(未招募)不适用

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

Attikon Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月1日最近更新:
干预措施

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

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

Active Comparator

Patients randomized to undergo the procedure with the audio system

干预措施: Neuromodulation auditory system (Device)

Group Control

No Intervention

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

发起方
Attikon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stavros Spiliopoulos

Professor of Diagnostic and Interventional Radiology

Attikon Hospital

研究点 (2)

Loading locations...

相似试验