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Music During ESWL for Entire Treatment

Primary Purpose

Urolithiasis

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Music

About this trial

This is an interventional supportive care trial for Urolithiasis focused on measuring Urolithiasis, Kidney Calculi, Lithotripsy, Pain Management, Music

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

AOU Città della Salute e della Scienza

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Music during ESWL

ESWL without music

Arm Description

Patients listen to music during ESWL

Patients don't listen to music during ESWL

Outcomes

Primary Outcome Measures

change in VAS score

Visual analogue scale (VAS) - 0 to 10, higher values, worse pain

Secondary Outcome Measures

change in Soundwave voltage (kV)

change in analgesic request

change in requested interruptions

change in Soundwave number

Full Information

NCT ID

NCT04380675

First Posted

December 4, 2015

Last Updated

May 7, 2020

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

1. Study Identification

Unique Protocol Identification Number

NCT04380675

Brief Title

Music During ESWL for Entire Treatment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

November 2, 2017 (Actual)

Primary Completion Date

July 18, 2018 (Actual)

Study Completion Date

July 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urolithiasis

Keywords

Urolithiasis, Kidney Calculi, Lithotripsy, Pain Management, Music

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Music during ESWL

Arm Type

Active Comparator

Arm Description

Patients listen to music during ESWL

Arm Title

ESWL without music

Arm Type

No Intervention

Arm Description

Patients don't listen to music during ESWL

Intervention Type

Other

Intervention Name(s)

Music

Intervention Description

Music listening during ESWL

Primary Outcome Measure Information:

Title

change in VAS score

Description

Visual analogue scale (VAS) - 0 to 10, higher values, worse pain

Time Frame

10 mins after SWL treatment completed

Secondary Outcome Measure Information:

Title

change in Soundwave voltage (kV)

Description

change in Soundwave voltage (kV)

Time Frame

10 mins after SWL treatment completed

Title

change in analgesic request

Description

change in analgesic request

Time Frame

10 mins after SWL treatment completed

Title

change in requested interruptions

Description

change in requested interruptions

Time Frame

10 mins after SWL treatment completed

Title

change in Soundwave number

Description

change in Soundwave number

Time Frame

10 mins after SWL treatment completed

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea Bosio, MD

Organizational Affiliation

AOU Città della Salute e della Scienza, Torino

Official's Role

Principal Investigator

Facility Information:

Facility Name

AOU Città della Salute e della Scienza

City

Turin

ZIP/Postal Code

10126

Country

Italy

12. IPD Sharing Statement

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Music During ESWL for Entire Treatment

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