Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-19 @ 1:07 AM
Study NCT ID:
NCT02265458
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2014-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Musical Intervention in Non-invasive Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-11', 'studyFirstSubmitDate': '2014-08-25', 'studyFirstSubmitQcDate': '2014-10-10', 'lastUpdatePostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of respiratory discomfort during the 30 first minutes of NIV', 'timeFrame': '30 minutes', 'description': 'Measure of respiratory discomfort at the beginning and the end of the first NIV session, with an analogic visual scale.'}], 'secondaryOutcomes': [{'measure': 'Evolution of respiratory parameters', 'timeFrame': 'participants will be followed for the duration of hospital stay or maximum 28 days', 'description': 'Measure of respiratory rate'}, {'measure': 'Evolution of respiratory parameters', 'timeFrame': 'participants will be followed for the duration of hospital stay or maximum 28 days', 'description': 'Transcutaneous oxygen saturation'}, {'measure': 'Evolution of respiratory parameters', 'timeFrame': 'participants will be followed for the duration of hospital stay or maximum 28 days', 'description': 'Respiratory tidal volume'}, {'measure': 'Number of NIV failure', 'timeFrame': 'participants will be followed for the duration of hospital stay or maximum 28 days', 'description': 'NIV failure'}, {'measure': 'Quality of life', 'timeFrame': '3 months', 'description': 'Questionnaire'}, {'measure': 'Evolution of cardiovascular parameters', 'timeFrame': 'participants will be followed for the duration of hospital stay or maximum 28 days', 'description': 'Measure of heart rate'}, {'measure': 'Evolution of cardiovascular parameters', 'timeFrame': 'participants will be followed for the duration of hospital stay or maximum 28 days', 'description': 'Measure of blood pressure'}, {'measure': 'Post traumatic stress disorder', 'timeFrame': '3 months', 'description': 'questionnaire'}, {'measure': 'overall assessment of NIV (in terms of discomfort, satisfaction, and trauma)', 'timeFrame': '3 months', 'description': 'Questionnaire (scale)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiratory failure', 'NIV', 'Musical intervention'], 'conditions': ['Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '27618935', 'type': 'DERIVED', 'citation': "Messika J, Hajage D, Panneckoucke N, Villard S, Martin Y, Renard E, Blivet A, Reignier J, Maquigneau N, Stoclin A, Puechberty C, Guetin S, Dechanet A, Fauquembergue A, Gaudry S, Dreyfuss D, Ricard JD. Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA). Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z."}]}, 'descriptionModule': {'briefSummary': 'Non-invasive ventilation (NIV) might be associated with anxiety, thus leading to NIV failure, and intubation. Music therapy has been used in various clinical context, including in ICU patients under mechanical ventilation. We aim to evaluate the effect of a musical intervention on respiratory comfort during NIV for acute respiratory failure.', 'detailedDescription': 'We plan a randomized controlled trial with 3 different arms, in ICU patients requiring NIV for acute respiratory failure : "usual care", "sensory isolation" and "sensory isolation and musical intervention".At the onset of respiratory failure, each patient will be randomized in one of the 3 arms. "Usual care" assigned patients will receive NIV according to each unit protocol; "sensory isolation" assigned patients will receive NIV associated with a mask obscuring the eyes and a noise-reducing headset."musical intervention patients" will receive a 30 minutes musical intervention during each NIV session. Respiratory discomfort will be blindly assessed before, immediately after NIV is correctly set (5 minutes), at 30 minutes, and at hours 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 according to NIV session length, and at the end of NIV session during each NIV session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* respiratory distress requiring NIV\n* Glasgow coma score above 12\n\nExclusion Criteria:\n\n* NIV contraindication : Hemodynamic failure, neurologic failure, head trauma, vomiting\n* Severe hypoacusis people without hearing device\n* Decision to limit active treatment with an estimated life expectancy of less than 48 hours'}, 'identificationModule': {'nctId': 'NCT02265458', 'acronym': 'Mus-IRA', 'briefTitle': 'Musical Intervention in Non-invasive Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Musical Intervention in the ICU: Effect on Tolerance and Acceptance of Non-invasive Ventilation', 'orgStudyIdInfo': {'id': 'P131201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Musical intervention and sensory isolation', 'description': '30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)', 'interventionNames': ['Behavioral: Musical intervention and sensory isolation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sensory isolation', 'description': 'Sensory isolation', 'interventionNames': ['Behavioral: Musical intervention and sensory isolation']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Standard of care'}], 'interventions': [{'name': 'Musical intervention and sensory isolation', 'type': 'BEHAVIORAL', 'description': '30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)', 'armGroupLabels': ['Musical intervention and sensory isolation', 'Sensory isolation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92700', 'city': 'Colombes', 'country': 'France', 'facility': 'Hôpital Louis Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CHD Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Jonathan MESSIKA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HP Louis Mourier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}