The effect of music on patients’ anxiety in minal-invasive procedures: a prospective randomized controlled trial.

Not Applicable

Recruiting

• Conditions: C56; C22.1; Malignant neoplasm of ovary; Intrahepatic bile duct carcinoma

• Registration Number: DRKS00026003
• Lead Sponsor: Charité Campus Virchow-Klinikum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

All patients who receive radiological intervention. Inclusion criteria are age of majority, hemodynamic stability, German speaking and ability to consent participation in the study.

Exclusion Criteria

Patients with hearing difficulties or dementia, emergency procedures and procedures under general anaesthesia will be excluded. Moreover, specific exclusion criteria for port procedure comprised haemorrhagic diathesis, thrombosis of jugular and subclavian veins, bilateral or acute infectious disease (e.g. sepsis or local implantation site infection) with increased risk of early port infection.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcomes of this study were defined as post-interventional state anxiety and the reduction of anxiety, meaning the difference of pre- to post-interventional anxiety levels, in order to analyze the influence of music exposure.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome parameters included mean heart rate and time of radiological surveillance for ports, which approximates the procedure duration.