Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT06783920
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-20
First Post:
2025-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MUSIC Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2025-01-15', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain during IUD insertion', 'timeFrame': '5 minutes', 'description': 'pain will be measured by the 10 cm visual analog scale where 0 denotes no pain, and 10 denotes worst pain felt'}], 'secondaryOutcomes': [{'measure': 'anxiety during IUD insertion', 'timeFrame': '5 minutes', 'description': 'anxiety will be measured by the 10 cm like visual analog scale where 0 denotes no anxiety, and 10 denotes maximal anxiety'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intrauterine Device']}, 'descriptionModule': {'briefSummary': 'The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women', 'detailedDescription': 'The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nulliparous women aged over 18 years of age requesting a copper IUD for contraception who had a negative pregnancy test.\n\nExclusion Criteria:\n\n* a prior pregnancy greater than 20 weeks of duration\n\n * currently pregnant or were pregnant within 6 weeks of study entry\n * had a prior attempted or successful IUD insertion\n * had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD active vaginitis or cervicitis\n * undiagnosed abnormal uterine bleeding\n * pelvic inflammatory disease within the last 3 months\n * fibroids or other uterine abnormalities distorting the uterine cavity'}, 'identificationModule': {'nctId': 'NCT06783920', 'briefTitle': 'MUSIC Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'EFFECT of MUSIC in Reducing Pain and Anxiety During Copper T380A Intrauterine Device Insertion in Nulliparous Women.', 'orgStudyIdInfo': {'id': 'music IUD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'music group', 'interventionNames': ['Procedure: music']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'no-music group', 'interventionNames': ['Procedure: no music']}], 'interventions': [{'name': 'music', 'type': 'PROCEDURE', 'description': 'music will be played during the copper IUD insertion', 'armGroupLabels': ['music group']}, {'name': 'no music', 'type': 'PROCEDURE', 'description': 'IUD insertion will be done as usual without music', 'armGroupLabels': ['no-music group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'AHMED ASHOUR, MD', 'role': 'CONTACT', 'email': 'ahmedsamy8233@gmail.com', 'phone': '35690992'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ahmed Samy aly ashour', 'investigatorAffiliation': 'Cairo University'}}}}