Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-02-25 @ 5:43 PM
Study NCT ID:
NCT01731834
Status:
COMPLETED
Last Update Posted:
2013-12-02
First Post:
2012-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain and Stress Assessment in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-08-20', 'releaseDate': '2014-08-04'}], 'estimatedResultsFirstSubmitDate': '2014-08-04'}}, '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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-27', 'studyFirstSubmitDate': '2012-11-18', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2013-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlate the pain and the stress generated.', 'timeFrame': 'two yars', 'description': 'Also assess heart rate, respiratory rate, and oxygen saturation.'}], 'primaryOutcomes': [{'measure': 'Assess whether there is pain in children when performed randomized technique', 'timeFrame': 'two years', 'description': 'Rate NIPS - Infant Pain Scale'}], 'secondaryOutcomes': [{'measure': 'Assess whether there is stress in children during the technical run', 'timeFrame': 'two years', 'description': 'Biochemical analysis of cortisol and salivary amylase'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'Stress', 'Physiotherapy', 'Children'], 'conditions': ['Acute Respiratory Infections']}, 'descriptionModule': {'briefSummary': 'There may be pain and / or stress with vibrocompression. There may be pain and / or stress with the aspiration of secretions.', 'detailedDescription': 'Randomization to 10 children and 10 vibrocompression for aspiration of secretion.\n\nFill in the evaluation form. Monitoring Heart Rate and Peripheral O2 Saturation (rest, during and after the technique performed).\n\nPhotographic Record (rest, during and after the technique performed). Saliva Collection (rest, 5, 20 and 40 minutes after running technics). Data analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication of Respiratory Therapy\n\nFasting for one hour before the moment of collection\n\nTerm of Free and Informed Consent Form (ICF) signed by parents or legal guardians\n\nExclusion Criteria:\n\n* Children in postoperative period acute\n\nPresence of thoracic drain or mediastinal\n\nChildren using drugs to sedative or analgesic purpose of deep sedation'}, 'identificationModule': {'nctId': 'NCT01731834', 'briefTitle': 'Pain and Stress Assessment in Children', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Uberlandia'}, 'officialTitle': 'Pain and Stress Assessment in Children Undergoing Respiratory Physical Therapy Techniques', 'orgStudyIdInfo': {'id': '11212PSC014'}, 'secondaryIdInfos': [{'id': 'FUUberlandia', 'type': 'REGISTRY', 'domain': 'FUUberlandia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aspiration of secretion', 'description': '10 children are evaluated at rest, during and after aspiration technique secretion', 'interventionNames': ['Other: Vibrocompression and aspiration of secretions']}, {'type': 'EXPERIMENTAL', 'label': 'Vibrocompression', 'description': '10 children will be assessed at rest, during and after the maneuver vibrocompression', 'interventionNames': ['Other: Vibrocompression and aspiration of secretions']}], 'interventions': [{'name': 'Vibrocompression and aspiration of secretions', 'type': 'OTHER', 'description': 'The 20 children, study participants will be randomly assigned to different groups, where 10 children will be evaluated during vibrocompression maneuver, and another 10 will be assessed on the aspiration procedure. Randomization will be performed using an opaque envelope for specifying which group selection technique is evaluated.', 'armGroupLabels': ['Aspiration of secretion', 'Vibrocompression']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uberlândia', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'FUUberlândia', 'geoPoint': {'lat': -18.91861, 'lon': -48.27722}}], 'overallOfficials': [{'name': 'Maria Biasi, Third', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FUUberlândia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Uberlandia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assessment of pain and stress in children undergoing respiratory physiotherapy', 'investigatorFullName': 'Maria Teresa de Mendonça Biasi', 'investigatorAffiliation': 'Federal University of Uberlandia'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-08-04', 'type': 'RELEASE'}, {'date': '2014-08-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Maria Teresa de Mendonça Biasi, Assessment of pain and stress in children undergoing respiratory physiotherapy, Federal University of Uberlandia'}}}}