NCT04338451

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

December 4, 2015

Last Update Submit

April 6, 2020

Conditions

Urolithiasis

Keywords

UrolithiasisKidney CalculiLithotripsyPain ManagementMusic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • percentage of patients who considered music useful to relieve pain

    10 mins after SWL treatment completed

  • change in SW voltage (kV)

    10 mins after SWL treatment completed

  • change in VAS score

    10 mins after SWL treatment completed

  • change in analgesic request

    10 mins after SWL treatment completed

  • change in requested interruptions

    10 mins after SWL treatment completed

  • +1 more secondary outcomes

Study Arms (2)

Music during the first part of ESWL

ACTIVE COMPARATOR

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

Other: Music during the first part of ESWL

Music during the second part of ESWL

ACTIVE COMPARATOR

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

Other: Music during the second part of ESWL

Interventions

Music during the first part of ESWLOTHER

Music listening during first part of ESWL

Music during the first part of ESWL
Music during the second part of ESWLOTHER

Music listening during second part of ESWL

Music during the second part of ESWL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing ESWL from February 2011 to October 2012 and interested in music listening

You may not qualify if:

  • Contraindication to ESWL
  • No interest in music listening
  • \< 18 years and \> 80 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Città della Salute e della Scienza

Turin, 10126, Italy

Location

MeSH Terms

Conditions

UrolithiasisKidney CalculiAgnosia

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephrolithiasisKidney DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Andrea MD Bosio, MD

    AOU città dellaSalute e della Scienza, Torino

    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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 4, 2015

First Posted

April 8, 2020

Study Start

February 2, 2017

Primary Completion

October 25, 2017

Study Completion

October 25, 2017

Last Updated

April 8, 2020

Record last verified: 2020-04

Locations

IT(1)