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Completed

NCT Number: NCT04338451

Music During ESWL for Half Treatment

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

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Key information

Conditions

Urolithiasis Agnosia Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Urinary Calculi Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Città della Salute e della Scienza

Turin, 10126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music during the first part of ESWL

Other

Music listening during first part of ESWL

Music during the second part of ESWL

Other

Music listening during second part of ESWL

Primary outcomes

  1. percentage of patients who appreciated music listening during SWL without anesthesia

    Time frame: 10 mins after SWL treatment completed

    patients were asked if they appreciated music listening during swl

Secondary outcomes

  1. percentage of patients who considered music useful to relieve pain

    Time frame: 10 mins after SWL treatment completed

    patients were asked if they considered music useful to relieve pain during swl

  2. change in SW voltage (kV)

    Time frame: 10 mins after SWL treatment completed

    change in SW voltage (kV)

  3. change in VAS score

    Time frame: 10 mins after SWL treatment completed

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

  4. change in analgesic request

    Time frame: 10 mins after SWL treatment completed

    change in analgesic request

  5. change in requested interruptions

    Time frame: 10 mins after SWL treatment completed

    change in requested interruptions

  6. change on VAS scores separately measured in each part of the treatment

    Time frame: 10 mins after SWL treatment completed

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

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 8, 2020
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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