Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT02040051
Status:
COMPLETED
Last Update Posted:
2021-07-27
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Sound Insulation and Music Therapy on the Comfort of Mechanically Ventilated Patients Admitted to Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-24', 'studyFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2014-01-17', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bispectral Index (BIS)', 'timeFrame': 'Up to 4 hours'}, {'measure': 'Ramsay sedation scale', 'timeFrame': 'Up to 4 hours'}, {'measure': 'Behaviour Pain Scale (BPS)', 'timeFrame': 'Up to 4 hours'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Up to 4 hours'}, {'measure': 'Heart rate', 'timeFrame': 'Up to 4 hours'}, {'measure': 'Respiratory frequency', 'timeFrame': 'Up to 4 hours'}, {'measure': 'Endotracheal aspirations', 'timeFrame': 'Up to 4 hours'}, {'measure': 'Administration of sedatives drugs', 'timeFrame': 'Up to 4 hours'}, {'measure': 'Administration of vasodilator and vasoconstrictor drugs', 'timeFrame': 'Up to 4 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intensive care units', 'mechanical ventilation', 'music therapy'], 'conditions': ['Intensive Care Units']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of sound insulation and music therapy on the comfort of mechanically ventilated patients admitted to intensive care unit measured by the Bispectral Index (BIS), the Ramsay sedation scale and the Behaviour Pain Scale (BPS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes\n* Patients over 18 years old\n* Patients with a level of consciousness BIS ≥ 50\n\nExclusion Criteria:\n\n* Patients with withholding treatment\n* Patients with partial or complete reduction of hearing in one or both ears\n* Patients with altered mental states: psychosis, schizophrenia, paranoia, neurosis, etc.\n* Patients with acute disease of the central nervous system: stroke, coma, encephalopathic process, etc.\n* Patients with an axillary temperature \\> 37.5º'}, 'identificationModule': {'nctId': 'NCT02040051', 'briefTitle': 'Efficacy of Sound Insulation and Music Therapy on the Comfort of Mechanically Ventilated Patients Admitted to Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Althaia Xarxa Assistencial Universitària de Manresa'}, 'officialTitle': 'Randomized Clinical Trial to Assess the Effect of Sound Insulation and Music Therapy on the Comfort of Mechanically Ventilated Patients Admitted to Intensive Care Unit', 'orgStudyIdInfo': {'id': 'CEIC 13/36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP A: Sound isolation / Music therapy', 'description': '* PREINTERVENTION: First hour. The patient will remain under the usual conditions of intensive care unit\n* INTERVENTION: Second hour. Sound isolation\n* INTERVENTION: Third hour. Music therapy\n* POSTINTERVENTION: Fourth hour. The patient will remain under the usual conditions of intensive care unit', 'interventionNames': ['Behavioral: Sound isolation / Music therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP B: Music therapy / Sound isolation', 'description': '* PREINTERVENTION: First hour. The patient will remain under the usual conditions of intensive care unit\n* INTERVENTION: Second hour. Music therapy\n* INTERVENTION: Third hour. Sound isolation\n* POSTINTERVENTION: Fourth hour. The patient will remain under the usual conditions of intensive care unit', 'interventionNames': ['Behavioral: Sound isolation / Music therapy']}], 'interventions': [{'name': 'Sound isolation / Music therapy', 'type': 'BEHAVIORAL', 'description': "Sound isolation: we will used headphones Noise Candelling HI-FI Polk Audio UF 8000 Control Talk for sound isolation.\n\nMusic therapy: we will used relaxing Zen music. Light Reiki Touch (Album: Merlin's Magic; Composer: Andreas Mock. Published in 1995 by Inner Worl Music)", 'armGroupLabels': ['GROUP A: Sound isolation / Music therapy', 'GROUP B: Music therapy / Sound isolation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08243', 'city': 'Manresa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Fundació Althaia Xarxa Assistencial Universitària de Manresa', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}], 'overallOfficials': [{'name': 'Marina Mateu, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Althaia Xarxa Assistencial Universitària de Manresa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Althaia Xarxa Assistencial Universitària de Manresa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse Bachelor', 'investigatorFullName': 'Marina Mateu-Capel', 'investigatorAffiliation': 'Althaia Xarxa Assistencial Universitària de Manresa'}}}}