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
Second Affiliated Hospital of 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

June 20, 2011
November 5, 2011
October 2008
October 2010   (final data collection date for primary outcome measure)
House-Brackmann scale (HBS) [ Time Frame: within 168 hours after onset of symptoms ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01377766 on ClinicalTrials.gov Archive Site
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The Relationship Between Psychological Factors and Bell's Palsy
Study of Psychological Factors on the Occurence of Bell's Palsy

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Probability Sample

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

Bell's Palsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
November 2011
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact: Wei Wang, doctor 86-027-8366-3648 wwang_tjh@126.com
China
 
NCT01377766
2006CB504502-3
Yes
Wei Wang, Huazhong University of Science and Technology
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
  • Second Affiliated Hospital of Zhengzhou University
  • Yichang Hospital of Traditional Chinese Medicine
  • Hebei Medical University First Hospital
  • Wuhan General Hospital of Guangzhou Command PLA
Principal Investigator: Wei Wang, doctor Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology
Huazhong University of Science and Technology
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP