Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-01-01 @ 5:58 AM
Study NCT ID:
NCT04330612
Status:
COMPLETED
Last Update Posted:
2020-04-01
First Post:
2020-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Family Updates Reduce Anxiety and Improve Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-20', 'size': 3779568, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-30T22:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2020-03-29', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Likert Score (0-5) of level of overall satisfaction', 'timeFrame': 'Overall satisfaction levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure.', 'description': 'Likert Score (0-5) of level of overall satisfaction of family members throughout the perioperative period'}, {'measure': 'Likert Score (0-5) of anxiety level', 'timeFrame': 'Anxiety levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure.', 'description': 'Likert Score (0-5) of anxiety level of family members throughout the perioperative period'}, {'measure': 'Likert Score (0-5) of level of satisfaction with perioperative updates', 'timeFrame': 'Satisfaction with perioperative updates measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure.', 'description': 'Likert Score (0-5) of level of satisfaction of family members with perioperative updates throughout the perioperative period'}], 'secondaryOutcomes': [{'measure': 'Spearman correlation between length of procedure and Likert score of anxiety level', 'timeFrame': 'Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Anxiety levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update.', 'description': 'Spearman correlation between length of procedure and Likert score (0-5) of anxiety level of family members throughout the perioperative period'}, {'measure': 'Spearman correlation between length of procedure and Likert score of overall satisfaction', 'timeFrame': 'Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Satisfaction level measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update.', 'description': 'Spearman correlation between length of procedure and Likert score (0-5) of overall satisfaction level of family members throughout the perioperative period'}, {'measure': 'Spearman correlation between length of procedure and Likert score of satisfaction with perioperative updates', 'timeFrame': 'Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Satisfaction level measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update.', 'description': 'Spearman correlation between length of procedure and Likert score of family member satisfaction with perioperative updates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Family Members', 'Anxiety', 'Satisfaction']}, 'descriptionModule': {'briefSummary': 'This study was a randomized control trial conducted to determine if frequent, standardized updates affect anxiety and satisfaction of family members. Additionally, the investigators aimed to determine if the length of the surgical procedure effects the satisfaction with updates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing inpatient arthroplasty, orthopaedic spine, or orthopaedic trauma procedures\n\nExclusion Criteria:\n\n* Age under 18\n* Non-English speaking patients or families\n* Patients with families that would not be waiting in the hospital during the perioperative period'}, 'identificationModule': {'nctId': 'NCT04330612', 'briefTitle': 'Perioperative Family Updates Reduce Anxiety and Improve Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont Medical Center'}, 'officialTitle': 'Perioperative Family Updates Reduce Anxiety and Improve Satisfaction: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CHRMS 16-642'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'In the control pathway, the surgeons communicated with the family only once near the completion of the procedure.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'In the intervention group, the families received additional standardized electronic updates via pagers.', 'interventionNames': ['Other: Perioperative Updates']}], 'interventions': [{'name': 'Perioperative Updates', 'type': 'OTHER', 'description': 'In the intervention group, the families received additional standardized electronic updates via pagers at three pivotal moments: 1) Initial skin incision has been made; 2) Critical part of the case is completed and closure has begun; and, 3) Closure is complete, and patient will be transferred to the recovery room when ready.', 'armGroupLabels': ['Intervention']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Researcher', 'investigatorFullName': 'Lindsay Howe', 'investigatorAffiliation': 'University of Vermont Medical Center'}}}}