We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

The Relationship Between Psychological Factors and Bell's Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01377766
Recruitment Status : Unknown
Verified November 2011 by Wei Wang, Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : June 21, 2011
Last Update Posted : November 8, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Bell's Palsy

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.

Study Design

Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Study of Psychological Factors on the Occurence of Bell's Palsy
Study Start Date : October 2008
Primary Completion Date : October 2010
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. House-Brackmann scale (HBS) [ Time Frame: within 168 hours after onset of symptoms ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
695 subjects were assigned to Cases Group (n=355) and Control Group (n=340).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377766

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

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
Second Affiliated Hospital of Zhengzhou University
Yichang Hospital of Traditional Chinese Medicine
The First Hospital of Hebei Medical University
Wuhan General Hospital of Guangzhou Military Command
Principal Investigator: Wei Wang, doctor Tongji Hospital
More Information

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
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

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

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