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

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.

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Key information

Conditions

Dialysis Access Dysfunction Endovascular Procedure Neuromodulation Patient Experience

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"ATTIKON" University General Hospital, , 1st Rimini St,, Athens, Select A State, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Dysfunctional vascular access (AVF or AVG) requiring endovascular treatment.
Balloon Angioplasty procedure
Stent graft procedure
Percutaneous declotting procedure

Exclusion criteria

Demenzia
Patient not tolerating headphones or music for any reason
Patients less than 18 years old
Patients unable to comprehend and complete the questionnaire

Treatment and study plan

Neuromodulation auditory system

Device

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).

Primary outcomes

Overall patient experience

Time frame: Within the first hour after the procedure

Completion of a standardized self-reported Stress-orientated questionnaire, with higher values indicating worst outcome.

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Mar 12, 2026
Registry last updated: Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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