Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-06 @ 2:53 AM
Study NCT ID:
NCT03226834
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of Favourite Versus Predetermined Musical Sequence on Gynecology Pre-operative Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'blindness concerns medical staff: nurses in charge of the blood parameters measurements as well as anxiety evaluation are not informed of the allocation of the patients'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'control randomized, single blind, monocentric'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-17', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-20', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Situation anxiety measurement', 'timeFrame': 'Change from baseline anxiety at 20 minutes musical listening', 'description': 'Pre-operative anxiety is assessed by the STAY-situation questionnaire'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Change from baseline blood pressure at 20 minutes musical listening', 'description': 'Measurement of blood pressure'}, {'measure': 'Post-operative pain', 'timeFrame': 'Up to one hour after surgery recovery', 'description': 'Pain is assessed after surgery recovery using Visual Analogic Scale'}, {'measure': 'Care stay duration', 'timeFrame': 'At study completion, an average of 3 days', 'description': 'Hospital stay is assessed by the number of days'}, {'measure': 'Post-operative complications', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'All post-operative complications are recorded'}, {'measure': 'Heart rate', 'timeFrame': 'Change from baseline heart at 20 minutes musical listening', 'description': 'Measurement of heart rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery', 'Anxiety State']}, 'referencesModule': {'references': [{'pmid': '34389022', 'type': 'DERIVED', 'citation': 'Reynaud D, Bouscaren N, Lenclume V, Boukerrou M. Comparing the effects of self-selected MUsic versus predetermined music on patient ANXiety prior to gynaecological surgery: the MUANX randomized controlled trial. Trials. 2021 Aug 13;22(1):535. doi: 10.1186/s13063-021-05511-2.'}, {'pmid': '30616674', 'type': 'DERIVED', 'citation': 'Petot T, Bouscaren N, Maillard O, Huiart L, Boukerrou M, Reynaud D. Comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery: a study protocol for a randomised controlled trial. Trials. 2019 Jan 7;20(1):20. doi: 10.1186/s13063-018-3093-6.'}]}, 'descriptionModule': {'briefSummary': "Anxiety is a psychologic and physiological state that could be characterized by somatic, emotional, cognitive and behavioral components. Surgery, as well as waiting for surgery is an anxiogenic situation encountered by 60 à 80 % of the patients. High levels of anxiety lead to negative physiological signs that slow down healing, lowers imune response and increases post-surgery infection. Anxiety also increases pain and post-surgery morbi-mortality. Drug-induced sedation is frequently recommended to lower anxiety. The anxiolytic effect of alternative treatment such as musicotherapy has been demonstrated in several randomized control trials. Nevertheless, most of these studies have investigated the effect of musicotherapy in groups with our without musical listening.\n\nIn the present study, investigators assume that a personal musical sequence composed by favourite songs of the patients could have beneficial effect on presurgical anxiety than selective sequence of the medical device MUSIC CARE.\n\nIn this study, the anxiolytic effect of predefined U musical sequences that alternate slow and faster music tracks (medical device MUSIC CARE) are compared to patient's play-list, in women with planned gynecological surgery.", 'detailedDescription': 'Patients are randomly allocated in two groups:\n\n* control group: patients are asked to choose one of the U sequence among the preselected music style proposed by the medical device MUSIC CARE\n* test group: patients are asked to prepare their own play-list containing their favourite songs\n\nAnxiety is assessed before and after a 20 min-musicotherapy session by using the State-Trait Anxiety Inventory (STAI) for anxiogenic situation.\n\nOther parameters are measured such as blood pressure, cardiac frequency, level of pain after surgery, care stay duration, potent post-surgery complications.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* with planed gynecologic surgery\n* without anxiolytic medication\n* able to prepare their own play-list\n* signed inform consent\n\nExclusion Criteria:\n\n* hearing disorder\n* dementia or psychiatric disorder\n* neurologic disorder'}, 'identificationModule': {'nctId': 'NCT03226834', 'acronym': 'MUANX', 'briefTitle': 'Efficiency of Favourite Versus Predetermined Musical Sequence on Gynecology Pre-operative Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Comparison of Musicotherapy Sessions Using Patient Play-list Versus U Sequence Music Care Medical Device on Pre-operative Anxiety in Women Undergoing Gynecological Surgery: a Randomized-control Study', 'orgStudyIdInfo': {'id': '2016/CHU/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MUSIC CARE', 'description': 'Listening for 20 min of one of the music style U sequences proposed by the medical device MUSIC CARE', 'interventionNames': ['Device: MUSIC CARE']}, {'type': 'EXPERIMENTAL', 'label': 'PERSONAL PLAY-LIST', 'description': "Listening for 20 min of patient's play-list", 'interventionNames': ['Other: PERSONAL PLAY-LIST']}], 'interventions': [{'name': 'MUSIC CARE', 'type': 'DEVICE', 'otherNames': ['Music Care U sequence'], 'description': 'Musicotherapy session using one of the U musical sequences of MUSIC CARE among the preselected music styles', 'armGroupLabels': ['MUSIC CARE']}, {'name': 'PERSONAL PLAY-LIST', 'type': 'OTHER', 'otherNames': ["Patient's paly-list"], 'description': "Musicotherapy session using the patient's play-list composed by the patient with her favourite songs", 'armGroupLabels': ['PERSONAL PLAY-LIST']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97410', 'city': 'Saint-Pierre', 'state': 'Reunion Island', 'country': 'Reunion', 'facility': 'Chu Reunion Island', 'geoPoint': {'lat': -21.3393, 'lon': 55.47811}}], 'overallOfficials': [{'name': 'Malik Boukerrou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hpospitalier Universitaire de La REUNION'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}