Music During ESWL for Half Treatment

Not Applicable

Completed

• Conditions: Urolithiasis
• Interventions: Other: Music during the first part of ESWL; Other: Music during the second part of ESWL

• Registration Number: NCT04338451
• 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 first part of the treatment (first 1800 SW), patients in group B during the second part.

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: 2017-02-02
• Primary Completion: 2017-10-25
• Study Completion: 2017-10-25
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-06
• Last Update Submitted: 2020-04-06
• Study First Posted: 2020-04-08
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• All patients undergoing ESWL from February 2011 to October 2012 and interested in music listening

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music during the first part of ESWL	Music during the first part of ESWL	Patients listen to music during the first part of ESWL treatment (first 1800 SW).
Music during the second part of ESWL	Music during the second part of ESWL	Patients listen to music during the second part of ESWL treatment.

Primary Outcome Measures

Name	Time	Method
percentage of patients who appreciated music listening during SWL without anesthesia	10 mins after SWL treatment completed	patients were asked if they appreciated music listening during swl

Secondary Outcome Measures

Name	Time	Method
change in SW voltage (kV)	10 mins after SWL treatment completed	change in SW voltage (kV)
percentage of patients who considered music useful to relieve pain	10 mins after SWL treatment completed	patients were asked if they considered music useful to relieve pain during swl
change in VAS score	10 mins after SWL treatment completed	Visual analogue scale (VAS) - 0 to 10, higher values, worse pain
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
change on VAS scores separately measured in each part of the treatment	10 mins after SWL treatment completed	Visual analogue scale (VAS) - 0 to 10, higher values, worse pain

Trial Locations

Locations (1)

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