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The Relationship Between Psychological Factors and Bell's Palsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Huazhong University of Science and Technology.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hubei Hospital of Traditional Chinese Medicine
Wuhan No.1 Hospital
Xiangyang No.1 People's Hospital
Renmin Hospital of Wuhan University
Fudan University
The Second Affiliated Hospital, Zhengzhou University
Yichang Hospital of Traditional Chinese Medicine
Hebei Medical University First Hospital
Wuhan General Hospital of Guangzhou Command PLA
Information provided by (Responsible Party):
Wei Wang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01377766
First received: June 20, 2011
Last updated: November 5, 2011
Last verified: November 2011
  Purpose

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.


Condition
Bell's Palsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Study of Psychological Factors on the Occurence of Bell's Palsy

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • House-Brackmann scale (HBS) [ Time Frame: within 168 hours after onset of symptoms ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: October 2008
Estimated Study Completion Date: November 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

695 subjects were assigned to Cases Group (n=355) and Control Group (n=340).

Criteria

Inclusion criteria:

  1. Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms;
  2. aged 18 to 65 years.

Exclusion criteria:

  1. illiterate;
  2. the facial paralysis is caused by herpes zoster;
  3. recurrent facial paralysis;
  4. noticeable asymmetry of the face before the illness which may affect the evaluation;
  5. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377766

Contacts
Contact: Wei Wang, doctor 86-027-8366-3648 wwang_tjh@126.com

Locations
China, Hubei
Institute of Integrated Traditional Chinese and Western Medicine Recruiting
Wuhan, Hubei, China
Contact: Guangying Huang, doctor    86-027-8366-3266    Gyhuang@tjh.tjmu.edu.cn   
Principal Investigator: Ling Liu, Doctor         
Principal Investigator: Guohua Chen, Doctor         
Principal Investigator: Guibin Zhang, Doctor         
Principal Investigator: Zhaohui Zhang, Doctor         
Principal Investigator: Xin Wang, Doctor         
Principal Investigator: Jianping Wang, Doctor         
Principal Investigator: Wei Zhang, Doctor         
Principal Investigator: Yuanwu Mei, Doctor         
Principal Investigator: Mingwei Wang, Doctor         
Principal Investigator: Honghua Li, Doctor         
Sponsors and Collaborators
Huazhong University of Science and Technology
Hubei Hospital of Traditional Chinese Medicine
Wuhan No.1 Hospital
Xiangyang No.1 People's Hospital
Renmin Hospital of Wuhan University
Fudan University
The Second Affiliated Hospital, Zhengzhou University
Yichang Hospital of Traditional Chinese Medicine
Hebei Medical University First Hospital
Wuhan General Hospital of Guangzhou Command PLA
Investigators
Principal Investigator: Wei Wang, doctor Huazhong University of Science and Technology
  More Information

No publications provided

Responsible Party: Wei Wang, Department of Neurology and Psychology, Tongji Hospital, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01377766     History of Changes
Other Study ID Numbers: 2006CB504502-3
Study First Received: June 20, 2011
Last Updated: November 5, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Huazhong University of Science and Technology:
Bell's palsy
psychological stress
personality factors
psychological factors

Additional relevant MeSH terms:
Bell Palsy
Facial Paralysis
Paralysis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014