Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-29 @ 1:59 PM
Study NCT ID:
NCT02883959
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Analgesic Effect of Music Therapy in Critically Ill Patients During Potentially Painful Nursing Procedures: a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-09', 'studyFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of pain exposure during nursing procedures', 'timeFrame': '150 minutes', 'description': 'total length of pain exposure to a BPS score over or equal to 5 divided by total length of nursing procedure'}], 'secondaryOutcomes': [{'measure': 'proportion of maximal pain exposure during nursing procedures', 'timeFrame': '150 minutes', 'description': 'Total length of exposure to the maximal BPS score (over or equal to 5) among total length of nursing procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['critically ill', 'mechanical ventilation', 'pain', 'nursing', 'music'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '30427906', 'type': 'DERIVED', 'citation': 'Jacq G, Melot K, Bezou M, Foucault L, Courau-Courtois J, Cavelot S, Lang A, Bedos JP, Le-Boeuf D, Boussard JM, Legriel S. Music for pain relief during bed bathing of mechanically ventilated patients: A pilot study. PLoS One. 2018 Nov 14;13(11):e0207174. doi: 10.1371/journal.pone.0207174. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Pain is a common problem encountered in about 60 % of critically ill patients who can communicate. Its occurrence can be related to several causes, mainly dominated by invasive procedures.\n\nPain management is typically based on a combination of prevention, evaluation, and therapeutic agents. However, it appears important to develop adjuvant approaches. Music therapy is one of them and that has been evaluated in various medical conditions.\n\nThe aim of our study is to evaluate the analgesic effect of music therapy in critically ill patients during potentially painful nursing procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients (ageā„18 years) hospitalized in Intensive Care Unit\n* Requiring mechanical ventilation\n* Who cannot communicate\n* With a Richmond Agitation Sedation Scale (RASS) score \\[-3; +4\\]\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Receiving neuromuscular blockade'}, 'identificationModule': {'nctId': 'NCT02883959', 'acronym': 'Painkiller', 'briefTitle': 'Evaluation of the Analgesic Effect of Music Therapy in Critically Ill Patients During Potentially Painful Nursing Procedures: a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Versailles Hospital'}, 'orgStudyIdInfo': {'id': '12/18_Painkiller'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'music therapy', 'description': 'Music therapy', 'interventionNames': ['Other: music therapy']}, {'type': 'NO_INTERVENTION', 'label': 'control arm', 'description': 'No music'}], 'interventions': [{'name': 'music therapy', 'type': 'OTHER', 'description': 'Music therapy will be delivered through headphones during nursing procedures (toilet and/or surgical dressings): from initiation up to 30 minutes after the end of procedure.', 'armGroupLabels': ['music therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Le Chesnay', 'country': 'France', 'facility': 'CH Versailles', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Versailles Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study principal investigator', 'investigatorFullName': 'LEGRIEL stephane', 'investigatorAffiliation': 'Versailles Hospital'}}}}