Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-27 @ 10:17 PM
Study NCT ID:
NCT05842356
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2023-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parental Feelings About Their Child Needing a Central Line
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants (parents) will not know which communication technique group they are in until after their participation.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2023-04-24', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parental Anxiety', 'timeFrame': '15 minutes', 'description': 'The parental anxiety survey is a tool used to measure levels of parental anxiety at the time of consent. Scores range from 7 to 28 with lower scores representing lower levels of anxiety.'}, {'measure': 'Parental Comfort Providing Consent', 'timeFrame': '15 minutes', 'description': 'The parental comfort providing consent survey score is a tool used to measure parental comfort in providing consent. Scores range from 0 to 24 with lower scores representing higher levels of comfort.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Central Venous Line (CVL)', 'Peripherally Inserted Central Catheter (PICC)'], 'conditions': ['Critical Illness', 'Children, Only', 'Stress']}, 'descriptionModule': {'briefSummary': 'The goal of this research project is to determine if different communication techniques during the consent process impact parental anxiety and comfort providing consent.', 'detailedDescription': 'The parents of children in the pediatric intensive care units (PICUs) at Columbia University may be asked if they are interested in participating in this study if their child needs a central venous line (CVL) or peripherally inserted central catheter (PICC) placed.\n\nIf the parents are interested in participating, they will be randomly assigned to a communication technique group while they are discussing the procedure and giving consent with a medical team member. After they provide consent, they will be asked to complete surveys about their thoughts and feelings. The study should take about 15 minutes.\n\nAfter data is collected, the researchers will compare survey answers between the two communication styles used with parents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent or guardian of a child admitted to the pediatric intensive care units (PICUs) at Columbia University\n* The child needs a central venous line (CVL) or peripherally inserted central catheter (PICC) placed in the PICU\n* The parent or guardian speaks English or Spanish\n\nExclusion Criteria:\n\n* Parents or guardians who speak languages other than English or Spanish\n* Parents or guardians of children who need a CVL or PICC placed during an emergency without consent\n* Parents or guardians who are unable to be physically present and provide consent over the phone'}, 'identificationModule': {'nctId': 'NCT05842356', 'briefTitle': 'Parental Feelings About Their Child Needing a Central Line', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Parental Feelings About Their Child Needing a Central Line', 'orgStudyIdInfo': {'id': 'AAAU3577'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Communication Technique 1', 'description': 'A standard communication technique will be used in this group.'}, {'type': 'EXPERIMENTAL', 'label': 'Communication Technique 2', 'description': 'A new communication technique will be used in this group.', 'interventionNames': ['Behavioral: Communication Technique 2']}], 'interventions': [{'name': 'Communication Technique 2', 'type': 'BEHAVIORAL', 'description': 'A new communication technique.', 'armGroupLabels': ['Communication Technique 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Columbia University New York-Presbyterian Morgan Stanley Children's Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jeffrey Edwards, MD, MA, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Jeffrey D. Edwards', 'investigatorAffiliation': 'Columbia University'}}}}