Music During ESWL for Entire Treatment

Not Applicable

Completed

• Conditions: Urolithiasis
• Interventions: Other: Music

• Registration Number: NCT04380675
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

Brief Summary

The aim of this study is to evaluate if music listening relieves pain and discomfort during Extracorporeal Shock-Waves Lithotripsy (ESWL).

Detailed Description

Patients undergoing ESWL and interested in music listening are randomly divided in two groups: patients in group A listen to music during the ESWL treatment, patients in group B do not.

At the end of the treatment patients are asked to fill in a questionnaire. They are asked if they were pleased to have had the opportunity to listen to music during ESWL, if they would like to listen to music again in case of further treatments, if they consider music helpful in relieving pain and discomfort during ESWL. Patients are also asked to mark their level of pain during each part of the treatment on a visual analogue scale (VAS) for pain.

Study Timeline

• Study First Submitted: 2015-12-04
• Study Start: 2017-11-02
• Primary Completion: 2018-07-18
• Study Completion: 2018-07-18
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-07
• Last Update Submitted: 2020-05-07
• Study First Posted: 2020-05-08
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• All patients undergoing ESWL and interested in music listening

Exclusion Criteria

• Contraindication to ESWL
• No interest in music listening
• Age < 18 and > 80

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music during ESWL	Music	Patients listen to music during ESWL

Primary Outcome Measures

Name	Time	Method
change in VAS score	10 mins after SWL treatment completed	Visual analogue scale (VAS) - 0 to 10, higher values, worse pain

Secondary Outcome Measures

Name	Time	Method
change in Soundwave number	10 mins after SWL treatment completed	change in Soundwave number
change in Soundwave voltage (kV)	10 mins after SWL treatment completed	change in Soundwave voltage (kV)
change in analgesic request	10 mins after SWL treatment completed	change in analgesic request
change in requested interruptions	10 mins after SWL treatment completed	change in requested interruptions

Trial Locations

Locations (1)

AOU Città della Salute e della Scienza; 🇮🇹 Turin, Italy