NCT07467642

A Neuromodulation Auditory System to Optimize Patient Experience During Dysfunctional Dialysis Access Endovascular Procedures

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Attikon Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dialysis Access Dysfunction
• Endovascular Procedure
• Patient Experience
• Neuromodulation

Interventions

Type	Name	Description
DEVICE	Neuromodulation auditory system	An MP3 audio system delivering via headphones, binaural beats, isochronic tones, and music designed to induce relaxation by achieving the alpha brainwave state (8-12Hz).

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-30
• Completion: 2026-03-30
• First posted: 2026-03-12
• Last updated: 2026-03-16

Locations

2 sites across 1 country: Greece