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

Attikon University Hospital

Status: Active, not recruiting

Conditions: Endovascular Procedure; Dialysis Access Dysfunction; Patient Experience; Neuromodulation

Treatments: Device: Neuromodulation auditory system

Study type: Interventional

Funder types: Other

Identifiers

NCT07467642

122730/15-11-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Group Sound

Active Comparator group

Description:

Patients randomized to undergo the procedure with the audio system

Treatment:

Device: Neuromodulation auditory system

Group Control

No Intervention group

Description:

Patients randomized to undergo the procedure without the audio system