Music During ESWL for Half Treatment

Study Overview
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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.

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

Conditions
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Urolithiasis

Intervention / Treatment
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* Other: Music during the first part of ESWL
* Other: Music during the second part of ESWL


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music during the first part of ESWL<br>Patients listen to music during the first part of ESWL treatment (first 1800 SW). | Other: Music during the first part of ESWL<br>* Music listening during first part of ESWL<br>|
| Active Comparator: Music during the second part of ESWL<br>Patients listen to music during the second part of ESWL treatment. | Other: Music during the second part of ESWL<br>* Music listening during second part of ESWL<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urolithiasis, Kidney Calculi, Lithotripsy, Pain Management, Music