Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT01658059
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2012-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006705', 'term': 'Homeopathy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'motim@ekmd.huji.ac.il', 'title': 'Moti Moskovitz', 'organization': 'Hadassah Medical Organization'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Homeopathic Remedy', 'description': 'Cross over design. Group 1 got homeopathic remedy on the first dental treatment. Group 2 got homeopathic remedy on the second treatment.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Cross over design. Group 1 got placebo on the second dental treatment. Group 2 got placebo on the first treatment.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Reducing Children's Anxiety", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Homeopathic Remedy', 'description': 'Group 1 got homeopathic remedy on the first dental treatment . Group 2 got homeopathic remedy on the second treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Group 2 got placebo on the first dental treatment . Group 1 got placebo on the second treatment.'}], 'classes': [{'title': 'cortisol pre treatment', 'categories': [{'measurements': [{'value': '1.38', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '2.28', 'spread': '3.09', 'groupId': 'OG001'}]}]}, {'title': 'cortisol post treatment', 'categories': [{'measurements': [{'value': '1.39', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '4.37', 'spread': '6.91', 'groupId': 'OG001'}]}]}, {'title': 'alpha amylase pre treatment', 'categories': [{'measurements': [{'value': '56.02', 'spread': '45.72', 'groupId': 'OG000'}, {'value': '92.09', 'spread': '110.65', 'groupId': 'OG001'}]}]}, {'title': 'alpha amylase post treatment', 'categories': [{'measurements': [{'value': '76.82', 'spread': '54.48', 'groupId': 'OG000'}, {'value': '102.62', 'spread': '104.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Each dental apointment, aproximatly 30 minutes on the average', 'description': 'Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Homeopathic Remedy First, Then Placebo', 'description': 'Homeopathic Remedy first, washout period and then Placebo'}, {'id': 'FG001', 'title': 'Placebo First, Then Homeopathic Remedy', 'description': 'Placebo first, washout period and then Homeopathic Remedy'}], 'periods': [{'title': 'First Intervention- 2 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}, {'title': 'Washout Period- 14 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention- 2 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Population', 'description': 'cross over design. Group 1 got homeopathic remedy on the first dental treatment, and placebo on the second treatment. Group 2 got placebo on the first dental treatment, homeopathic remedy on the second treatment'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.09', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Israel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2012-07-21', 'resultsFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2012-08-03', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-19', 'studyFirstPostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Reducing Children's Anxiety", 'timeFrame': 'Each dental apointment, aproximatly 30 minutes on the average', 'description': 'Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Children's Dental Anxiety"]}, 'descriptionModule': {'briefSummary': "Pharmacological interventions to aid behavior management's techniques are commonly used in pediatric dentistry. The aim of the medicaments is to control behavior and allow safe completion of a dental procedure. Homeopathic remedy is safe and can be effective to control behavior and decrease anxiety in children during dental treatment.\n\nAim: 1. To explore the efficacy of homeopathic drugs in decreasing children's dental anxiety before dental treatment.\n\n2\\. To assess the effectiveness of homeopathic remedy in facilitating dental treatment for anxious children.\n\nMethods: prospective, double-blind study. Thirty healthy children (5-12 years-old) will receive homeopathic remedy\\\\placebo before dental treatment. Anxiety reduction will be measured using: saliva cortisol levels, saliva α-amylase levels, facial image scale (FIS), and Houpt behavior scale.\n\nExpected results: the homeopathic remedy will reduce anxiety and increase child cooperation during dental treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dental anxiety\n* Needs at least 2 dental treatment appointments\n\nExclusion Criteria:\n\n* Medically compromised\n* Cooperative, needs less than 2 dental treatment appointments'}, 'identificationModule': {'nctId': 'NCT01658059', 'briefTitle': "Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment", 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': "Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment", 'orgStudyIdInfo': {'id': 'rcauhr-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'description': 'homeopathic remedy first , placebo second', 'interventionNames': ['Other: Homeopathic remedy', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'group 2', 'description': 'placebo first, homeopathic remedy second', 'interventionNames': ['Other: Homeopathic remedy', 'Other: Placebo']}], 'interventions': [{'name': 'Homeopathic remedy', 'type': 'OTHER', 'description': 'drops of the homeopathic remedy will be taken twice a day before the treatment and once on the morning of the treatment day.', 'armGroupLabels': ['group 1', 'group 2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'drops of the placebo will be taken twice a day before the treatment and once on the morning of the treatment day.', 'armGroupLabels': ['group 1', 'group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical senior lecturer, department of pediatric dentistry', 'investigatorFullName': 'Moti Moskovitz', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}