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Music During ESWL for Half Treatment

Primary Purpose

Urolithiasis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Music during the first part of ESWL
Music during the second part of ESWL
Sponsored by
Azienda Ospedaliera Città della Salute e della Scienza di Torino
About
Eligibility
Locations
Arms
Outcomes
Full info

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 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

Sites / Locations

  • AOU Città della Salute e della Scienza

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Music during the first part of ESWL

Music during the second part of ESWL

Arm Description

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

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

Outcomes

Primary Outcome Measures

percentage of patients who appreciated music listening during SWL without anesthesia
patients were asked if they appreciated music listening during swl

Secondary Outcome Measures

percentage of patients who considered music useful to relieve pain
patients were asked if they considered music useful to relieve pain during swl
change in SW voltage (kV)
change in SW voltage (kV)
change in VAS score
Visual analogue scale (VAS) - 0 to 10, higher values, worse pain
change in analgesic request
change in analgesic request
change in requested interruptions
change in requested interruptions
change on VAS scores separately measured in each part of the treatment
Visual analogue scale (VAS) - 0 to 10, higher values, worse pain

Full Information

First Posted
December 4, 2015
Last Updated
April 6, 2020
Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino
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1. Study Identification

Unique Protocol Identification Number
NCT04338451
Brief Title
Music During ESWL for Half Treatment
Official Title
Music Listening to Decrease Pain and Discomfort During Extracorporeal Shock Wave Lithotripsy (SWL): a Prospective Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
October 25, 2017 (Actual)
Study Completion Date
October 25, 2017 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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 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.

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
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music during the first part of ESWL
Arm Type
Active Comparator
Arm Description
Patients listen to music during the first part of ESWL treatment (first 1800 SW).
Arm Title
Music during the second part of ESWL
Arm Type
Active Comparator
Arm Description
Patients listen to music during the second part of ESWL treatment.
Intervention Type
Other
Intervention Name(s)
Music during the first part of ESWL
Intervention Description
Music listening during first part of ESWL
Intervention Type
Other
Intervention Name(s)
Music during the second part of ESWL
Intervention Description
Music listening during second part of ESWL
Primary Outcome Measure Information:
Title
percentage of patients who appreciated music listening during SWL without anesthesia
Description
patients were asked if they appreciated music listening during swl
Time Frame
10 mins after SWL treatment completed
Secondary Outcome Measure Information:
Title
percentage of patients who considered music useful to relieve pain
Description
patients were asked if they considered music useful to relieve pain during swl
Time Frame
10 mins after SWL treatment completed
Title
change in SW voltage (kV)
Description
change in SW voltage (kV)
Time Frame
10 mins after SWL treatment completed
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
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 on VAS scores separately measured in each part of the treatment
Description
Visual analogue scale (VAS) - 0 to 10, higher values, worse pain
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
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea MD Bosio, MD
Organizational Affiliation
AOU città dellaSalute e della Scienza, Torino
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andrea MD Bosio, MD
Organizational Affiliation
AOU città dellaSalute e della Scienza, Torino
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea MD Bosio, MD
Organizational Affiliation
AOU città dellaSalute e della Scienza, Torino
Official's Role
Study Director
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 Half Treatment

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