Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-06 @ 11:00 PM
Study NCT ID:
NCT03670420
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2018-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Application of Honey on Perineal Sutures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2018-09-04', 'studyFirstSubmitQcDate': '2018-09-11', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change between groups in perceived pain scores on the visual analog scale at day 1 post-partum', 'timeFrame': 'Day 1', 'description': 'A Visual Analogue Scale (VAS) is used by women to evaluate perceived pain. The score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater pain intensity.\n\nPain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.'}, {'measure': 'Saint Antoine questionnaire to measure perceived pain at day 1 post-partum', 'timeFrame': 'Day 1', 'description': 'Participants complete the Saint Antoine questionnaire (1), a french version of the short form Mcgill pain questionnaire. Mcgill pain questionnaire can be used to evaluate a person experiencing significant pain. Women use a Likert 5 points scale to assess words that describe their pain : Absent, Low, Moderate, High Extremely, High.\n\nPain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.'}, {'measure': 'Mean change between groups in perceived pain scores on the visual analog scale at day 4 post-partum', 'timeFrame': 'Day 4', 'description': 'A Visual Analogue Scale (VAS) is used by women to evaluate perceived pain. The score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater pain intensity.\n\nPain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.'}, {'measure': 'Saint Antoine questionnaire to measure perceived pain at day 4 post-partum', 'timeFrame': 'Day 4', 'description': 'Participants complete the Saint Antoine questionnaire (1), a french version of the short form Mcgill pain questionnaire. Mcgill pain questionnaire can be used to evaluate a person experiencing significant pain. Women use a Likert 5 points scale to assess words that describe their pain : Absent, Low, Moderate, High Extremely, High.\n\nPain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.'}], 'secondaryOutcomes': [{'measure': 'Mean change between groups in peceived burn scores on the visual analog scale at day 1 post-partum', 'timeFrame': 'Day 1', 'description': 'A Visual Analogue Scale (VAS) is used to measure burning sentation. The score is determined by measuring the distance (mm) on the 100 mm line between the "no burn" anchor and the patient\'s mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater burn intensity.\n\nBurning sensation is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.'}, {'measure': 'Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1', 'timeFrame': 'Day 1', 'description': 'Women included in the intervention group complete a five points Likert scale ( Not at all, Very few, Few, Satisfied, Very satisfied) to evaluate their satisfaction with the application of honey on their perineal sutures.\n\nWoman satisfaction about honey application is evaluate at two different times (day 1 and 4) in order to objectify changes between the two measurement times.'}, {'measure': 'Mean change between groups in peceived burn scores on the visual analog scale at day 4 post-partum', 'timeFrame': 'Day 4', 'description': 'A Visual Analogue Scale (VAS) is used to measure burning sentation. The score is determined by measuring the distance (mm) on the 100 mm line between the "no burn" anchor and the patient\'s mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater burn intensity.\n\nBurning sensation is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times.'}, {'measure': 'Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1', 'timeFrame': 'Day 4', 'description': 'Women included in the intervention group complete a five points Likert scale ( Not at all, Very few, Few, Satisfied, Very satisfied) to evaluate their satisfaction with the application of honey on their perineal sutures.\n\nWoman satisfaction about honey application is evaluate at two different times (day 1 and 4) in order to objectify changes between the two measurement times.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perineal Tear', 'Pain', 'Burns']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'https://doi.org/10.1007/s11724-008-0083-6'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1007/s11724-008-0083-6', 'label': 'The psychometric caractéristiques of the Saint Antoine Questionnaire'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the effect of honey on perineal tears or episiotomies pain associated or not with anterior vulvar tears after vaginal delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major women\n* Giving birth vaginally in the maternity of Geneva university hospital\n* First and second degree perineal tears or episiotomy\n* French speaking women\n* The day of the delivery\n\nExclusion Criteria:\n\n* Allergic to honey and bees\n* Drug use\n* postpartum hemorrhage'}, 'identificationModule': {'nctId': 'NCT03670420', 'briefTitle': 'The Application of Honey on Perineal Sutures', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'The Application of Honey on Perineal Sutures: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2018-00995'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medical honey in addition to standard care', 'description': 'In addition to the usual care provided by the maternity unit, women allocated to this group apply honey on first and second degree perineal tears, episiotomies and anterior vulvar tears twice a day for four days from randomization.', 'interventionNames': ['Other: Medical honey']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'This group benefits from the standard care offered by the maternity: hygiene advice, analgesics, ice packs, buoys and positioning.'}], 'interventions': [{'name': 'Medical honey', 'type': 'OTHER', 'description': 'The investigators use Medihoney®, a medical honey released by the DermaSciences.', 'armGroupLabels': ['Medical honey in addition to standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1206', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Geneva University Hospitals', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marie-Julia GUITTIER', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}