NCT04380675

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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 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
1.9 years until next milestone

Study Start

First participant enrolled

November 2, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2018

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

9 months

First QC Date

December 4, 2015

Last Update Submit

May 7, 2020

Conditions

Urolithiasis

Keywords

UrolithiasisKidney CalculiLithotripsyPain ManagementMusic

Outcome Measures

Primary Outcomes (1)

  • change in VAS score

    Visual analogue scale (VAS) - 0 to 10, higher values, worse pain

    10 mins after SWL treatment completed

Secondary Outcomes (4)

  • change in Soundwave voltage (kV)

    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

  • change in Soundwave number

    10 mins after SWL treatment completed

Study Arms (2)

Music during ESWL

ACTIVE COMPARATOR

Patients listen to music during ESWL

Other: Music

ESWL without music

NO INTERVENTION

Patients don't listen to music during ESWL

Interventions

MusicOTHER

Music listening during ESWL

Music during 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 and interested in music listening

You may not qualify if:

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

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

Interventions

Music Therapy

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

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Andrea Bosio, MD

    AOU Città della Salute e della Scienza Torino

    PRINCIPAL INVESTIGATOR

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

May 8, 2020

Study Start

November 2, 2017

Primary Completion

July 18, 2018

Study Completion

July 18, 2018

Last Updated

May 8, 2020

Record last verified: 2020-05

Locations

IT(1)