Music During ESWL for Half Treatment

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

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

Study Overview

• Status: Completed
• Conditions: Urolithiasis
• Intervention / Treatment: Other: Music during the first part of ESWL; Other: Music during the second part of 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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • AOU Città della Salute e della Scienza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Music during the first part of ESWL; Patients listen to music during the first part of ESWL treatment (first 1800 SW).	Other: Music during the first part of ESWL; Music listening during first part of ESWL
ACTIVE_COMPARATOR: Music during the second part of ESWL; Patients listen to music during the second part of ESWL treatment.	Other: Music during the second part of ESWL; Music listening during second part of ESWL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in VAS score	Visual analogue scale (VAS) - 0 to 10, higher values, worse pain	10 mins after SWL treatment completed
change in analgesic request	change in analgesic request	10 mins after SWL treatment completed
change in requested interruptions	change in requested interruptions	10 mins after SWL treatment completed
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
change in SW voltage (kV)	change in SW voltage (kV)	10 mins after SWL treatment completed
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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Investigators: Study Chair: Andrea MD Bosio, MD, AOU città dellaSalute e della Scienza, Torino; Principal Investigator: Andrea MD Bosio, MD, AOU città dellaSalute e della Scienza, Torino; Study Director: Andrea MD Bosio, MD, AOU città dellaSalute e della Scienza, Torino

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2017
• Primary Completion (ACTUAL): October 25, 2017
• Study Completion (ACTUAL): October 25, 2017

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (ACTUAL): April 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Lithotripsy; Urolithiasis; Music; Pain Management; Kidney Calculi
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: AOUCSSTURAB001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No