Music During ESWL for Half Treatment

Urolithiasis Clinical Trial

Official title:

Music Listening to Decrease Pain and Discomfort During Extracorporeal Shock Wave Lithotripsy (SWL): a Prospective Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04338451
• Other study ID #: AOUCSSTURAB001
• Status: Completed
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: October 25, 2017

Study information

• Verified date: April 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 25, 2017
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Other:
• Music during the first part of ESWL
Music listening during first part of ESWL
• Music during the second part of ESWL
Music listening during second part of 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	percentage of patients who appreciated music listening during SWL without anesthesia	patients were asked if they appreciated music listening during swl	10 mins after SWL treatment completed
Secondary	percentage of patients who considered music useful to relieve pain	patients were asked if they considered music useful to relieve pain during swl	10 mins after SWL treatment completed
Secondary	change in SW voltage (kV)	change in SW voltage (kV)	10 mins after SWL treatment completed
Secondary	change in VAS score	Visual analogue scale (VAS) - 0 to 10, higher values, worse pain	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 on VAS scores separately measured in each part of the treatment	Visual analogue scale (VAS) - 0 to 10, higher values, worse pain	10 mins after SWL treatment completed