Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT01020032
Status:
COMPLETED
Last Update Posted:
2009-11-25
First Post:
2009-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Music Therapy on Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-24', 'studyFirstSubmitDate': '2009-11-23', 'studyFirstSubmitQcDate': '2009-11-24', 'lastUpdatePostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on a Visual Analogical Scale (VAS) for actual pain', 'timeFrame': 'Day 0, day 5, day 10, day 60 and day 90'}], 'secondaryOutcomes': [{'measure': 'Score on the Hospital Anxiety and Depression (HAD) Scale', 'timeFrame': 'Day 0, day 5, day 10, day 60 and day 90'}, {'measure': 'Medicinal consumption', 'timeFrame': 'Before hospitalization, day 0, day 5, day 10, day 60 and day 90'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Music therapy', 'Pain', 'Anxiety', 'Depression', 'Controlled randomized trial'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '17532141', 'type': 'BACKGROUND', 'citation': 'Roy M, Peretz I, Rainville P. Emotional valence contributes to music-induced analgesia. Pain. 2008 Jan;134(1-2):140-7. doi: 10.1016/j.pain.2007.04.003. Epub 2007 May 25.'}, {'pmid': '16625614', 'type': 'BACKGROUND', 'citation': 'Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.'}, {'pmid': '19628939', 'type': 'BACKGROUND', 'citation': "Guetin S, Portet F, Picot MC, Pommie C, Messaoudi M, Djabelkir L, Olsen AL, Cano MM, Lecourt E, Touchon J. Effect of music therapy on anxiety and depression in patients with Alzheimer's type dementia: randomised, controlled study. Dement Geriatr Cogn Disord. 2009;28(1):36-46. doi: 10.1159/000229024. Epub 2009 Jul 23."}], 'seeAlsoLinks': [{'url': 'http://www.amarc.fr', 'label': 'AMARC association is specialized in applications and clinical researches in music therapy'}]}, 'descriptionModule': {'briefSummary': 'The aim of study is to assess the effects of this new music therapy technique on pain treatment, anxiety and depression and on medicinal consumption.', 'detailedDescription': 'The "U" technique is a music therapy method of recent use developed by taking into account recommendations of the scientific literature. The objective of the study is to evaluate this method on chronic painful patients presenting a lumbago, a fibromyalgia, an inflammatory or neurological pathology. During the hospitalization, the intervention group benefited from at least 2 daily sessions of music therapy between day 0 and day 10, and continued the musicotherapy at home until day 60. The evaluated criteria are pain, depression and anxiety and their evolution after 60 days of treatment (since the inclusion). The evaluation at day 90 allows to test the persistence of the effect of the music therapy 90 days later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a pain for more than 6 months\n* Pain of neurological origin (fibromyalgia, algodystrophies), or skeletal musculous (back, sciatic nerve)\n* Speak and read French fluently\n* Wrote consent of patients\n* Benefit from the standard treatment : Intravenous treatment (tranquillizer, antidepressive) the first 5 days, 2 time by day (in the morning and evening), followed by the intermediary orally up to the exit (prescribed doses and at request)\n\nExclusion Criteria:\n\n* Time of hospitalization \\< 8 days\n* Reflex epilepsy history\n* Major insufficiency of auditory function\n* Patient with a strong possibility of not compliance to the protocol or of abandon in the course of study\n* Presence of an illness threatening vital forecast during period envisaged for the study'}, 'identificationModule': {'nctId': 'NCT01020032', 'briefTitle': 'Effect of Music Therapy on Pain', 'organization': {'class': 'OTHER', 'fullName': 'Association de Musicothérapie Applications et Recherches Cliniques'}, 'officialTitle': 'Effect of Music Therapy on Chronic Pain in Hospitalized Patients in a Pain Center', 'orgStudyIdInfo': {'id': 'AMARC 200801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music therapy', 'description': 'Individual receptive music therapy by "U sequence" method', 'interventionNames': ['Other: Individual receptive music therapy by "U sequence" method']}], 'interventions': [{'name': 'Individual receptive music therapy by "U sequence" method', 'type': 'OTHER', 'description': 'During the hospitalization, the intervention group benefited from at least 2 daily sessions of music therapy between day 0 and day 10, and continued the musicotherapy at home until day 60.', 'armGroupLabels': ['Music therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': "CHRU Saint Eloi, Centre d'Evaluation et du Traitement de la Douleur", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Stéphane GUETIN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Association de Musicothérapie Applications et Recherches Cliniques'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association de Musicothérapie Applications et Recherches Cliniques', 'class': 'OTHER'}, 'collaborators': [{'name': "Centre d'Evaluation et du Traitement de la Douleur CHU Saint-Eloi", 'class': 'UNKNOWN'}, {'name': 'Unité de Recherche Clinique et Epidémiologie (DIM) CHU Arnaud de Villeneuve', 'class': 'UNKNOWN'}, {'name': 'Centre Mémoire de Ressource et de Recherche équipe INSERM U888 CHU Montpellier', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'GUETIN', 'oldOrganization': 'AMARC'}}}}