The Relationship Between Psychological Factors and Bell's Palsy

November 5, 2011 updated by: Wei Wang, Huazhong University of Science and Technology

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Institute of Integrated Traditional Chinese and Western Medicine
        • 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:
          • Yuanwu Mei, Doctor
        • Principal Investigator:
          • Mingwei Wang, Doctor
        • Principal Investigator:
          • Honghua Li, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
House-Brackmann scale (HBS)
Time Frame: within 168 hours after onset of symptoms
within 168 hours after onset of symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Collaborators

Fudan University
Second Affiliated Hospital of Zhengzhou University
Renmin Hospital of Wuhan University
The First Hospital of Hebei Medical University
Hubei Hospital of Traditional Chinese Medicine
Wuhan No.1 Hospital
Wuhan General Hospital of Guangzhou Military Command
Yichang Hospital of Traditional Chinese Medicine
Xiangyang No.1 People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ANTICIPATED)

November 1, 2011

Study Registration Dates

First Submitted

June 20, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (ESTIMATE)

June 21, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 5, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006CB504502-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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