Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-27 @ 4:25 PM
Study NCT ID:
NCT01377766
Status:
UNKNOWN
Last Update Posted:
2011-11-08
First Post:
2011-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Psychological Factors and Bell's Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020330', 'term': 'Bell Palsy'}, {'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-05', 'studyFirstSubmitDate': '2011-06-20', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'House-Brackmann scale (HBS)', 'timeFrame': 'within 168 hours after onset of symptoms'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Bell's palsy", 'psychological stress', 'personality factors', 'psychological factors'], 'conditions': ["Bell's Palsy"]}, 'descriptionModule': {'briefSummary': "The aim of this study was to explore the risk factors for Bell's palsy (BP) and to examine whether psychological factors are the potential risk factors for the occurrence of BP.", 'detailedDescription': 'We conducted a case-control, multi-center clinical investigation. A total of 695 subjects were assigned to the case group (n=355) and the control group (n=340). All the BP patients were enrolled from 11 State Hospitals in China, and all the controls were selected from the same district to match for the patients. The study was coordinated by a tertiary referral centre, Tongji Hospital. The House-Brackmann grading system and Facial Disability Index (FDI) was adopted to assess the BP patients. Kessler 10-Item Psychological Distress Scale（K10）was usde to explore the psychological distress, and the Cattell 16 Personality Factor (16PF) scale was employed to evaluate the personality profiles of all subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '695 subjects were assigned to Cases Group (n=355) and Control Group (n=340).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms;\n2. aged 18 to 65 years.\n\nExclusion criteria：\n\n1. illiterate;\n2. the facial paralysis is caused by herpes zoster;\n3. recurrent facial paralysis;\n4. noticeable asymmetry of the face before the illness which may affect the evaluation;\n5. history of peptic ulcer disease, severe hypertension, uncontrolled diabetes, liver and kidney dysfunction, pregnancy, mental illness, or serious systemic diseases which may affect the treatment.'}, 'identificationModule': {'nctId': 'NCT01377766', 'briefTitle': "The Relationship Between Psychological Factors and Bell's Palsy", 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': "Study of Psychological Factors on the Occurence of Bell's Palsy", 'orgStudyIdInfo': {'id': '2006CB504502-3'}}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangying Huang, doctor', 'role': 'CONTACT', 'email': 'Gyhuang@tjh.tjmu.edu.cn', 'phone': '86-027-8366-3266'}, {'name': 'Ling Liu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Guohua Chen, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Guibin Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zhaohui Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xin Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jianping Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wei Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yuanwu Mei, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mingwei Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Honghua Li, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Integrated Traditional Chinese and Western Medicine', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Wei Wang, doctor', 'role': 'CONTACT', 'email': 'wwang_tjh@126.com', 'phone': '86-027-8366-3648'}], 'overallOfficials': [{'name': 'Wei Wang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hubei Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Wuhan No.1 Hospital', 'class': 'OTHER'}, {'name': "Xiangyang No.1 People's Hospital", 'class': 'OTHER'}, {'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'Yichang Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'The First Hospital of Hebei Medical University', 'class': 'OTHER'}, {'name': 'Wuhan General Hospital of Guangzhou Military Command', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Neurology and Psychology, Tongji Hospital', 'investigatorFullName': 'Wei Wang', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}