Music During ESWL for Half Treatment

NCT ID: NCT04338451

Last Updated: 2020-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-02

Study Completion Date

2017-10-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Music during the first part of ESWL

Patients listen to music during the first part of ESWL treatment (first 1800 SW).

Group Type ACTIVE_COMPARATOR

Music during the first part of ESWL

Intervention Type OTHER

Music listening during first part of ESWL

Music during the second part of ESWL

Patients listen to music during the second part of ESWL treatment.

Group Type ACTIVE_COMPARATOR

Music during the second part of ESWL

Intervention Type OTHER

Music listening during second part of ESWL

Interventions

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Music during the first part of ESWL

Music listening during first part of ESWL

Intervention Type OTHER

Music during the second part of ESWL

Music listening during second part of ESWL

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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A.O.U. Città della Salute e della Scienza

OTHER

Sponsor Role lead

Responsible Party

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Andrea Bosio

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea MD Bosio, MD

Role: STUDY_CHAIR

AOU città dellaSalute e della Scienza, Torino

Andrea MD Bosio, MD

Role: PRINCIPAL_INVESTIGATOR

AOU città dellaSalute e della Scienza, Torino

Andrea MD Bosio, MD

Role: STUDY_DIRECTOR

AOU città dellaSalute e della Scienza, Torino

Locations

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AOU Città della Salute e della Scienza

Turin, , Italy

Site Status

Countries

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Italy

Other Identifiers

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AOUCSSTURAB001

Identifier Type: -

Identifier Source: org_study_id

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