Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-22 @ 1:03 PM
Study NCT ID:
NCT02922504
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2016-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Music Intervention on Pain Control In First Trimester Surgical Abortion Under Local Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2016-09-27', 'studyFirstSubmitQcDate': '2016-09-30', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the effectiveness on the pain of music therapy by the pain evaluation with visual numeric scale', 'timeFrame': 'during one day', 'description': 'evaluation is maide five times'}]}, 'conditionsModule': {'keywords': ['First trimester abortion', 'Surgical abortion', 'Music intervention', 'Local anesthesia', 'Pain'], 'conditions': ['First Trimester Abortion', 'Surgical Abortion', 'Music Intervention', 'Local Anesthesia', 'Pain']}, 'descriptionModule': {'briefSummary': 'A surgical abortion under local anesthesia is potentially painful. A protocol using analgetic is systematically used. Also the protocol is relevant , the question of taking care of the pain in a safe manner remains.\n\nThe use of Music during surgery can have a real effect on pain and anxiety. This study has for goal to evalued the use of music on pain as adjuvant treatement instead of a standard care for an abortion.', 'detailedDescription': 'A surgical abortion under local anesthesiac is potentially painful. A protocol using analgetic is systematically used. Also the protocol is relevant, the question of taking care of the pain in a safe manner remains.\n\nThe use of Music during surgery can have a real effect on pain and anxiety. This study has for goal to evalued the use of music on pain as adjuvant treatment instead of a standard care for an abortion.\n\nThe number of patients needed is estimate to be eighty patients per group.\n\nThe result of the study could allow :\n\n* Showing the effectiveness of music intervention before operative abortion as adjuvant treatment on the pain, anxiety and nausea during a surgical abortion by suction aspiration under local anesthesia.\n* Improving the experience of an abortion and the satisfaction of the patients as well as lowering the use of drugs.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Every patients must have more than 18 years old\n* Hospitalised at the Angers Hospital for a surgical abortion under local anesthesia.\n* Affiliated or be part of the french Sécurité Sociale ( health service )\n* To have signed a consent form\n\nExclusion Criteria:\n\n* Patients not speaking french\n* People who should not use music intervention ( Total or partial hearing difficulties)\n* No consent given\n* Adults protected by the law\n* Not being part of another medical study'}, 'identificationModule': {'nctId': 'NCT02922504', 'acronym': 'AlgoMusic', 'briefTitle': 'Impact of Music Intervention on Pain Control In First Trimester Surgical Abortion Under Local Anesthesia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Impact of Music Intervention on Pain Control In First Trimester Surgical Abortion Under Local Anesthesia', 'orgStudyIdInfo': {'id': '49RC16_0073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music intervention group', 'description': 'For the patients in the Music intervention group, a adjuvant treament by a music intervention will be use before the procedure', 'interventionNames': ['Behavioral: Music intervention group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Controlled group', 'description': 'For the patients in the " controlled " group, the use of analgesic will be use if needed during the procedure', 'interventionNames': ['Behavioral: Controlled group']}], 'interventions': [{'name': 'Music intervention group', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Music intervention group']}, {'name': 'Controlled group', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Controlled group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}