Music During ESWL for Entire Treatment

May 7, 2020 updated by: Andrea Bosio, Azienda Ospedaliera Città della Salute e della Scienza di Torino

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

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

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 and interested in music listening

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Music during ESWL
Patients listen to music during ESWL
Other: Music
Music listening during ESWL
NO_INTERVENTION: ESWL without music
Patients don't listen to music during ESWL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in VAS score
Time Frame: 10 mins after SWL treatment completed
Visual analogue scale (VAS) - 0 to 10, higher values, worse pain
10 mins after SWL treatment completed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Soundwave voltage (kV)
Time Frame: 10 mins after SWL treatment completed
change in Soundwave voltage (kV)
10 mins after SWL treatment completed
change in analgesic request
Time Frame: 10 mins after SWL treatment completed
change in analgesic request
10 mins after SWL treatment completed
change in requested interruptions
Time Frame: 10 mins after SWL treatment completed
change in requested interruptions
10 mins after SWL treatment completed
change in Soundwave number
Time Frame: 10 mins after SWL treatment completed
change in Soundwave number
10 mins after SWL treatment completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Investigators

  • Principal Investigator: Andrea Bosio, MD, AOU Città della Salute e della Scienza, Torino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 2, 2017

Primary Completion (ACTUAL)

July 18, 2018

Study Completion (ACTUAL)

July 18, 2018

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

May 7, 2020

First Posted (ACTUAL)

May 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOUCSSTURAB002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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