Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-28 @ 2:01 PM
Study NCT ID:
NCT00795392
Status:
COMPLETED
Last Update Posted:
2009-09-18
First Post:
2008-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Psychological Evaluation as Predictor of Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-17', 'studyFirstSubmitDate': '2008-11-20', 'studyFirstSubmitQcDate': '2008-11-20', 'lastUpdatePostDateStruct': {'date': '2009-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of recovery', 'timeFrame': 'Since the end of the operation (1 day) to six-month follow-up.'}], 'secondaryOutcomes': [{'measure': 'Intraoperative consumption of drugs', 'timeFrame': 'From the time of start of operation (0 min) to the end of the surgical procedures, this time will undergo alteration in different individuals'}, {'measure': 'Hospitalization days', 'timeFrame': 'Time length of staying at hospital from the day of inpatient to discharge home, this time will undergo alteration in different individuals'}, {'measure': 'Life quality', 'timeFrame': 'Since the end of the operation (1 day) to six-month follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Psychology', 'Postoperative outcome', 'Surgical Operation'], 'conditions': ['Elective Surgery']}, 'descriptionModule': {'briefSummary': 'Perioperative psychological care is increasingly recognized as an essential part in the surgical environment. Previous studies have developed a strategy to evaluate the psychological influence after operations and found that postoperative psychological states significantly associated with the outcomes of patients. However, preoperative evaluation of patients the physicians do thus far is mainly the physical status assessment following the scale of American Society of Anesthesiologists (ASA). Whether a full-scale evaluation of preoperative psychological status to surgical patients could be a predictor to postoperative outcomes or not is not still completely understood. The investigators hypothesized that the preoperative psychological assessment would be an important predictor to outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All types of patients undergoing surgical operations', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective surgical operation\n* Age from 18-65 years\n\nExclusion Criteria:\n\n* Age \\<18 years or \\>65 years\n* Not willing to participate in this study\n* Patients from emergency department'}, 'identificationModule': {'nctId': 'NCT00795392', 'acronym': 'PEPO', 'briefTitle': 'Preoperative Psychological Evaluation as Predictor of Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Preoperative Psychological Evaluation as Predictor of Post-surgical Outcomes', 'orgStudyIdInfo': {'id': 'NJMU200811010'}, 'secondaryIdInfos': [{'id': 'NJFY0811008'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients assessed with ASA physical status scale', 'interventionNames': ['Other: ASA scale']}, {'label': '2', 'description': 'Patients assessed with full-scale psychological factors', 'interventionNames': ['Other: Full-scale psychological assessment']}], 'interventions': [{'name': 'ASA scale', 'type': 'OTHER', 'description': 'ASA scale evaluation before operation', 'armGroupLabels': ['1']}, {'name': 'Full-scale psychological assessment', 'type': 'OTHER', 'description': 'Full-scale psychological evaluation before operation', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210004', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Maternal and Child Health Care Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'XiaoFeng Shen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'XiaoFeng Shen', 'oldOrganization': 'Nanjing Medical University'}}}}