Music During ESWL for Entire Treatment

Urolithiasis Clinical Trial

Official title:

Music Listening to Decrease Pain and Discomfort During Extracorporeal Shock Wave Lithotripsy (ESWL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380675
• Other study ID #: AOUCSSTURAB002
• Status: Completed
• Phase: N/A
• Start date: November 2, 2017
• Est. completion date: July 18, 2018

Study information

• Verified date: May 2020
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 18, 2018
• Est. primary completion date: July 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Other:
• Music
Music listening during ESWL

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in VAS score	Visual analogue scale (VAS) - 0 to 10, higher values, worse pain	10 mins after SWL treatment completed
Secondary	change in Soundwave voltage (kV)	change in Soundwave voltage (kV)	10 mins after SWL treatment completed
Secondary	change in analgesic request	change in analgesic request	10 mins after SWL treatment completed
Secondary	change in requested interruptions	change in requested interruptions	10 mins after SWL treatment completed
Secondary	change in Soundwave number	change in Soundwave number	10 mins after SWL treatment completed