Music During ESWL for Half Treatment

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino (Other)

Overall Status

Completed

CT.gov ID

NCT04338451

Collaborator

(none)

Enrollment

Location

Arms

8.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Urolithiasis	Other: Music during the first part of ESWL Other: Music during the second part of ESWL	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 2, 2017

Actual Primary Completion Date :

Oct 25, 2017

Actual Study Completion Date :

Oct 25, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Music during the first part of ESWL Patients listen to music during the first part of ESWL treatment (first 1800 SW).	Other: Music during the first part of ESWL Music listening during first part of ESWL
Active Comparator: Music during the second part of ESWL Patients listen to music during the second part of ESWL treatment.	Other: Music during the second part of ESWL Music listening during second part of ESWL

Arm

Intervention/Treatment

Active Comparator: Music during the first part of ESWL

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

Other: Music during the first part of ESWL

Music listening during first part of ESWL

Active Comparator: Music during the second part of ESWL

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

Other: Music during the second part of ESWL

Music listening during second part of ESWL

Outcome Measures

Primary Outcome Measures

percentage of patients who appreciated music listening during SWL without anesthesia [10 mins after SWL treatment completed]
patients were asked if they appreciated music listening during swl

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Città della Salute e della Scienza	Turin		Italy	10126

Sponsors and Collaborators

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Investigators

Study Chair: Andrea MD Bosio, MD, AOU città dellaSalute e della Scienza, Torino
Principal Investigator: Andrea MD Bosio, MD, AOU città dellaSalute e della Scienza, Torino
Study Director: Andrea MD Bosio, MD, AOU città dellaSalute e della Scienza, Torino