Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-03-28 @ 9:26 AM
Study NCT ID:
NCT01803204
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2013-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient Education Before Orthognathic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D008844', 'term': 'Micrognathism'}, {'id': 'D011378', 'term': 'Prognathism'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'crissousa@usp.br', 'phone': '+5511996017972', 'title': 'Cristina Sousa', 'organization': 'USP'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "It's possible lack of patient adherence to educational intervention, which would lead to lower intervention response rates and the possible use of other technologies during the process."}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Booklet - Preoperative Educational', 'description': 'This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase\n\nBooklet - Preoperative Educational: the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': "This group don't received booklet, they will be monitored during the postoperative period to control", 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Clinical Changes During the Postoperative Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Booklet - Preoperative Educational', 'description': 'This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase\n\nBooklet - Preoperative Educational: the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.'}, {'id': 'OG001', 'title': 'Control', 'description': "This group don't received booklet, they will be monitored during the postoperative period to control"}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GEE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '1.00', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'this measure will be assessed weekly in the first forty days postoperatively (seventh day, fourteenth day, twenty-first day and fortieth day after the surgery)', 'description': "A review of the patient's recovery after surgery will occur during follow-up visits with the surgeon, It was rated the care of oral hygiene, nutrition, mobility and sensitivity, appearance of lips, swelling, pain and sleep . The patient will be accompanied by the researcher during the return and the data will be evaluated and investigated as annotated patient outcomes.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Test Arrangements on Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Booklet - Preoperative Educational', 'description': 'This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase\n\nBooklet - Preoperative Educational: the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.'}, {'id': 'OG001', 'title': 'Control', 'description': "This group don't received booklet, they will be monitored during the postoperative period to control"}], 'classes': [{'title': 'Pos-op First visit', 'categories': [{'measurements': [{'value': '6.5', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.94', 'groupId': 'OG001'}]}]}, {'title': 'Pos -op Thrid visit', 'categories': [{'measurements': [{'value': '6.8', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '2.21', 'groupId': 'OG001'}]}]}, {'title': 'Pos-op Fourth visit', 'categories': [{'measurements': [{'value': '7.00', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '5.20', 'spread': '2.32', 'groupId': 'OG001'}]}]}, {'title': 'Pre-operatively', 'categories': [{'measurements': [{'value': '4.20', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '4.30', 'spread': '2.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'statisticalMethod': 'Mist Effects Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'This will be delivered in the first contact with the patient before surgery and on the seventh day after surgery', 'description': "The patient's knowledge about the surgery will be assessed by a test developed by the researcher (A test with 10 multiple choice questions, each questions with 4 alternatives, about care after surgery. Each questions value 1 point, for better results was considered higher 7 points and for worse results was considered low 5 points. A total value for the Knowledge test was 10 points (rage 0-10) The acceptable score to understand that the patient is aware of the surgery was 7.\n\nThis was applied on two occasions: first contact with the patient before surgery, signed a consent form before the start researcher educational intervention (during the preoperative phase).\n\nThe second test will be given at the first follow-up visit with the surgeon (seventh postoperative day)", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Levels of Anxiety After Educational Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Booklet - Preoperative Educational', 'description': 'This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase\n\nBooklet - Preoperative Educational: the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.'}, {'id': 'OG001', 'title': 'Control', 'description': "This group don't received booklet, they will be monitored during the postoperative period to control"}], 'classes': [{'title': 'Pre-operatively S-STAI anxiety', 'categories': [{'measurements': [{'value': '39.30', 'spread': '12.13', 'groupId': 'OG000'}, {'value': '45.20', 'spread': '10.45', 'groupId': 'OG001'}]}]}, {'title': 'Pos -op First visit S-STAI anxiety', 'categories': [{'measurements': [{'value': '35.8', 'spread': '11.37', 'groupId': 'OG000'}, {'value': '40.10', 'spread': '11.24', 'groupId': 'OG001'}]}]}, {'title': 'Pos-op Third visit S-STAI anxiety', 'categories': [{'measurements': [{'value': '33.90', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '36.70', 'spread': '10.39', 'groupId': 'OG001'}]}]}, {'title': 'Pos-op Fourth visit S-STAI anxiety', 'categories': [{'measurements': [{'value': '34.40', 'spread': '10.21', 'groupId': 'OG000'}, {'value': '37.20', 'spread': '10.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'statisticalMethod': 'Mist Effect Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'The STAI will be applied on the seventh day after surgery', 'description': 'The levels of anxiety during the perioperative period will be measured with the State-Trait Anxiety Inventory (STAI).\n\nThe STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety sub-scales Responses for the S-Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the T-Anxiety scale assess fre- quency of feelings "in general": 1) almost never, 2) some- times, 3) often, and 4) almost always.\n\nScoring. Item scores are added to obtain subtest total scores. Scoring should be reversed for anxiety-absent items (19 items of the total 40).\n\nScore interpretation. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale For results this intervention was considered S-STAI Anxiety with lower scores (\\< 39) after the intervention', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Booklet - Preoperative Educational', 'description': 'This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase\n\nBooklet - Preoperative Educational: the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.'}, {'id': 'FG001', 'title': 'Control', 'description': "This group don't received booklet, they will be monitored during the postoperative period to control"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'For the pilot study and testing of the evaluation printed were contacted 8 patients as intervention group and control group not applied.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Booklet - Preoperative Educational', 'description': 'This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase\n\nBooklet - Preoperative Educational: the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.'}, {'id': 'BG001', 'title': 'Control', 'description': "This group don't received booklet, they will be monitored during the postoperative period to control"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '27.4', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '27.1', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2013-02-25', 'resultsFirstSubmitDate': '2016-01-17', 'studyFirstSubmitQcDate': '2013-02-28', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-21', 'studyFirstPostDateStruct': {'date': '2013-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Levels of Anxiety After Educational Intervention', 'timeFrame': 'The STAI will be applied on the seventh day after surgery', 'description': 'The levels of anxiety during the perioperative period will be measured with the State-Trait Anxiety Inventory (STAI).\n\nThe STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety sub-scales Responses for the S-Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the T-Anxiety scale assess fre- quency of feelings "in general": 1) almost never, 2) some- times, 3) often, and 4) almost always.\n\nScoring. Item scores are added to obtain subtest total scores. Scoring should be reversed for anxiety-absent items (19 items of the total 40).\n\nScore interpretation. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale For results this intervention was considered S-STAI Anxiety with lower scores (\\< 39) after the intervention'}], 'primaryOutcomes': [{'measure': 'Number of Patients With Clinical Changes During the Postoperative Recovery', 'timeFrame': 'this measure will be assessed weekly in the first forty days postoperatively (seventh day, fourteenth day, twenty-first day and fortieth day after the surgery)', 'description': "A review of the patient's recovery after surgery will occur during follow-up visits with the surgeon, It was rated the care of oral hygiene, nutrition, mobility and sensitivity, appearance of lips, swelling, pain and sleep . The patient will be accompanied by the researcher during the return and the data will be evaluated and investigated as annotated patient outcomes."}], 'secondaryOutcomes': [{'measure': 'Average Test Arrangements on Surgery', 'timeFrame': 'This will be delivered in the first contact with the patient before surgery and on the seventh day after surgery', 'description': "The patient's knowledge about the surgery will be assessed by a test developed by the researcher (A test with 10 multiple choice questions, each questions with 4 alternatives, about care after surgery. Each questions value 1 point, for better results was considered higher 7 points and for worse results was considered low 5 points. A total value for the Knowledge test was 10 points (rage 0-10) The acceptable score to understand that the patient is aware of the surgery was 7.\n\nThis was applied on two occasions: first contact with the patient before surgery, signed a consent form before the start researcher educational intervention (during the preoperative phase).\n\nThe second test will be given at the first follow-up visit with the surgeon (seventh postoperative day)"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anxiety', 'Orthognathic surgery', 'Patient educational as topic', 'Patient educational handout', 'Pamphlets'], 'conditions': ['Malocclusion', 'Anxiety', 'Micrognathism', 'Prognathism']}, 'referencesModule': {'references': [{'pmid': '23250262', 'type': 'BACKGROUND', 'citation': 'dos Santos MR, Sousa CS, Turrini RN. [Perception of orthognathic surgery patients on postoperative care]. Rev Esc Enferm USP. 2012 Oct;46 Spec No:78-85. doi: 10.1590/s0080-62342012000700012. Portuguese.'}, {'type': 'BACKGROUND', 'citation': 'Sousa CS, Turrini RNT. Validação de constructo de tecnologia educativa para pacientes mediante aplicação da técnica Delphi. Acta Paulista de Enfermagem. 2012;25(6):990-6.'}, {'pmid': '25031119', 'type': 'BACKGROUND', 'citation': 'Sousa CS, Turrini RN. Creating and validating educational material for patients undergoing orthognathic surgery. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Dec;6(4):166-72. doi: 10.1016/j.anr.2012.10.006. Epub 2012 Nov 7.'}, {'type': 'BACKGROUND', 'citation': 'Sousa CS, Turrini RNT. Complications in orthognathic surgery: A comprehensive review. Journal of Oral and Maxillofacial Surgery, Medicine, and Pathology. 2012;24:67-74.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness in the use of an educational material through: Assessment of knowledge about post-operative orthognathic surgery; assessing levels of anxiety with the survey of Anxiety Inventory-STATE-TRAIT; clinical evaluation of self-care in the management of postoperative signs and symptoms', 'detailedDescription': 'It is a clinical randomized controlled trial being developed from February 2013 to September 2015, divided into two phases: a pilot study without randomization for impact testing and evaluation of intervention and, in the second time, the clinical randomized study with possible changes after the pilot study.\n\nWill be entered in the study patients undergoing maxillofacial surgery originating at outpatient clinic located in the municipality of São Paulo. The study aims to evaluate the effects of educational material in postoperative education orthognathic surgery, with intervals between pre and postoperative serials.\n\nRecruitment plan of patients: the patients seen in oral and maxillofacial surgery and traumatology clinic located in the municipality of São Paulo with indication for orthognathic surgery will be covered by personally and invited to participate in intervention research. To control the bias will be included in the study patients of the same surgical team, to ensure the same surgical technique and postoperative guidance conduct by the surgeon.\n\nStudy variables: it is intended to analyse the socio-demographic variables: sex, age, level of education; independent variables: surgical technique, recovery time, difficulties experienced during the postoperative period, possible surgical complications; dependent variables: signs and symptoms postoperatively (presence or absence) and monitoring of care during the postoperative period; level of knowledge about the post-op of orthognathic surgery and anxiety levels (State-trait anxiety inventory-IDATE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing orthognathic surgery during the study and with surgical technique:\n\n * sagittal maxillary bilateral osteotomy;\n * maxillary;\n * vertical osteotomy;\n * Lefort I osteotomy combined with or without mentoplastia and maxillary disjunction.\n* Informed consent\n* Patients in the maxillofacial outpatient clinic located at Sao Paulo\n\nExclusion Criteria:\n\n* patients undergoing reoperation of orthognathic surgery;\n* with cleft lip-palate.'}, 'identificationModule': {'nctId': 'NCT01803204', 'briefTitle': 'Patient Education Before Orthognathic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Evaluation of an Educational Booklet for Perioperative Orthognathic Surgery: Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '193.454'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Booklet - Preoperative Educational', 'description': 'This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase', 'interventionNames': ['Other: Booklet - Preoperative Educational']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "This group don't received booklet, they will be monitored during the postoperative period to control"}], 'interventions': [{'name': 'Booklet - Preoperative Educational', 'type': 'OTHER', 'description': 'the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.', 'armGroupLabels': ['Booklet - Preoperative Educational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04116020', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Cristina Silva Sousa', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Cristina S Sousa, MsC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Student PhD', 'investigatorFullName': 'Cristina Silva Sousa', 'investigatorAffiliation': 'University of Sao Paulo'}}}}