Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT03005795
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2016-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music and Colposcopy in Women With Cervical Dysplasia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-07', 'studyFirstSubmitDate': '2016-12-25', 'studyFirstSubmitQcDate': '2016-12-28', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in anxiety scores', 'timeFrame': '10 minutes before and after colposcopy', 'description': 'Each women completes the state anxiety questionnaire (state-trait anxiety inventory \\[STAI\\]) 10 minutes before and 10 minutes after colposcopy. The difference in scores before and after colposcopy will be measured.'}], 'secondaryOutcomes': [{'measure': 'Anxiety score after colposcopy', 'timeFrame': '10 minutes before and after colposcopy', 'description': 'Each women completes the state anxiety questionnaire (state-trait anxiety inventory \\[STAI\\]) 10 minutes after colposcopy.'}, {'measure': 'Change in heart rate', 'timeFrame': '10 minutes', 'description': 'The difference in heart rate before and after colposcopy will be measured.'}, {'measure': 'Pain during examination', 'timeFrame': '10 minutes', 'description': "women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain')."}, {'measure': 'Pain after examination', 'timeFrame': '10 minutes', 'description': "women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain')."}, {'measure': 'general unpleasantness during examination', 'timeFrame': '10 minutes', 'description': 'women scores their feeeling during colposcopy using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("not at all unpleasant") to 10 ("extremely unpleasant").'}, {'measure': 'Anxiety during examination', 'timeFrame': '10 minutes', 'description': 'women scores their anxiety during colposcopy using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("no anxiety at all") to 10 ("worst imaginable anxiety")'}, {'measure': 'Overall Satisfaction', 'timeFrame': '10 minutes', 'description': 'women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical dysplasia', 'colposcopy', 'anxiety', 'music', 'mozart', 'randomized controlled trial'], 'conditions': ['Uterine Cervical Dysplasia']}, 'referencesModule': {'references': [{'pmid': '30204685', 'type': 'DERIVED', 'citation': 'Hilal Z, Alici F, Tempfer CB, Rath K, Nar K, Rezniczek GA. Mozart for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial. Obstet Gynecol. 2018 Oct;132(4):1047-1055. doi: 10.1097/AOG.0000000000002876.'}]}, 'descriptionModule': {'briefSummary': 'To assess the effect of music during colposcopy on women´s anxiety.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women referred for colposcopy due to cervical abnormalities\n* We included women if they attended colposcopy for the first time\n\nExclusion Criteria:\n\n* pregnant women\n* presence of a language barrier\n* known anxiety disorder or depression\n* history of conization or other treatments on the cervix uteri\n* known oncological disorder\n* auditory defect\n* cardiovascular disease\n* inadequate colposcopy'}, 'identificationModule': {'nctId': 'NCT03005795', 'briefTitle': 'Music and Colposcopy in Women With Cervical Dysplasia.', 'organization': {'class': 'OTHER', 'fullName': 'Zydolab - Institute of Cytology and Immune Cytochemistry'}, 'officialTitle': 'Does Mozart Reduces Anxiety in Women With Cervical Dysplasia? A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'COLPO-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music and colposcopy', 'description': 'Women will hear Mozarts symphony Nr. 40 during the colposcopic examination', 'interventionNames': ['Device: Headphones']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Colposcopy without music', 'description': 'During the colposcopic examination women will not hear music', 'interventionNames': ['Other: No Headphones']}], 'interventions': [{'name': 'Headphones', 'type': 'DEVICE', 'description': 'Music can be heard through headphones', 'armGroupLabels': ['Music and colposcopy']}, {'name': 'No Headphones', 'type': 'OTHER', 'description': 'No Headphones will be used.', 'armGroupLabels': ['Colposcopy without music']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44137', 'city': 'Dortmund', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Zydolab - Institute of Cytology and Immune Cytochemistry', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '44625', 'city': 'Herne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Department of Obstetrics and Gynecology of the Ruhr University Bochum', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}], 'overallOfficials': [{'name': 'Ziad Hilal, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zydolab - Institute of Cytology and Immune Cytochemistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zydolab - Institute of Cytology and Immune Cytochemistry', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}