Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT04338451
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2015-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Music During ESWL for Half Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2015-12-04', 'studyFirstSubmitQcDate': '2020-04-06', 'lastUpdatePostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients who appreciated music listening during SWL without anesthesia', 'timeFrame': '10 mins after SWL treatment completed', 'description': 'patients were asked if they appreciated music listening during swl'}], 'secondaryOutcomes': [{'measure': 'percentage of patients who considered music useful to relieve pain', 'timeFrame': '10 mins after SWL treatment completed', 'description': 'patients were asked if they considered music useful to relieve pain during swl'}, {'measure': 'change in SW voltage (kV)', 'timeFrame': '10 mins after SWL treatment completed', 'description': 'change in SW voltage (kV)'}, {'measure': 'change in VAS score', 'timeFrame': '10 mins after SWL treatment completed', 'description': 'Visual analogue scale (VAS) - 0 to 10, higher values, worse pain'}, {'measure': 'change in analgesic request', 'timeFrame': '10 mins after SWL treatment completed', 'description': 'change in analgesic request'}, {'measure': 'change in requested interruptions', 'timeFrame': '10 mins after SWL treatment completed', 'description': 'change in requested interruptions'}, {'measure': 'change on VAS scores separately measured in each part of the treatment', 'timeFrame': '10 mins after SWL treatment completed', 'description': 'Visual analogue scale (VAS) - 0 to 10, higher values, worse pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urolithiasis', 'Kidney Calculi', 'Lithotripsy', 'Pain Management', 'Music'], 'conditions': ['Urolithiasis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate if music listening relieves pain and discomfort during Extracorporeal Shock-Waves Lithotripsy (ESWL).', 'detailedDescription': '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.\n\nAt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing ESWL from February 2011 to October 2012 and interested in music listening\n\nExclusion Criteria:\n\n* Contraindication to ESWL\n* No interest in music listening\n* \\< 18 years and \\> 80 years'}, 'identificationModule': {'nctId': 'NCT04338451', 'briefTitle': 'Music During ESWL for Half Treatment', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': 'Music Listening to Decrease Pain and Discomfort During Extracorporeal Shock Wave Lithotripsy (SWL): a Prospective Randomized Trial.', 'orgStudyIdInfo': {'id': 'AOUCSSTURAB001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Music during the first part of ESWL', 'description': 'Patients listen to music during the first part of ESWL treatment (first 1800 SW).', 'interventionNames': ['Other: Music during the first part of ESWL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Music during the second part of ESWL', 'description': 'Patients listen to music during the second part of ESWL treatment.', 'interventionNames': ['Other: Music during the second part of ESWL']}], 'interventions': [{'name': 'Music during the first part of ESWL', 'type': 'OTHER', 'description': 'Music listening during first part of ESWL', 'armGroupLabels': ['Music during the first part of ESWL']}, {'name': 'Music during the second part of ESWL', 'type': 'OTHER', 'description': 'Music listening during second part of ESWL', 'armGroupLabels': ['Music during the second part of ESWL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'country': 'Italy', 'facility': 'AOU Città della Salute e della Scienza', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'overallOfficials': [{'name': 'Andrea MD Bosio, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AOU città dellaSalute e della Scienza, Torino'}, {'name': 'Andrea MD Bosio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AOU città dellaSalute e della Scienza, Torino'}, {'name': 'Andrea MD Bosio, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AOU città dellaSalute e della Scienza, Torino'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Andrea Bosio', 'investigatorAffiliation': 'A.O.U. Città della Salute e della Scienza'}}}}