The Relationship Between Psychological Factors and Bell's Palsy

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Unknown status

CT.gov ID

NCT01377766

Collaborator

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

800

Enrollment

Location

Duration (Months)

21.6

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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

Anticipated 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 :

Oct 1, 2008

Actual Primary Completion Date :

Oct 1, 2010

Anticipated Study Completion Date :

Nov 1, 2011

Outcome Measures

Primary Outcome Measures

House-Brackmann scale (HBS) [within 168 hours after onset of symptoms]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

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

Exclusion criteria：

illiterate;
the facial paralysis is caused by herpes zoster;
recurrent facial paralysis;
noticeable asymmetry of the face before the illness which may affect the evaluation;
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

Locations

	Site	City	State	Country	Postal Code
1	Institute of Integrated Traditional Chinese and Western Medicine	Wuhan	Hubei	China

Investigators

Principal Investigator: Wei Wang, doctor, Tongji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wei Wang, Department of Neurology and Psychology, Tongji Hospital, Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT01377766

Other Study ID Numbers:

2006CB504502-3

First Posted:

Jun 21, 2011

Last Update Posted:

Nov 8, 2011

Last Verified:

Nov 1, 2011

Keywords provided by Wei Wang, Department of Neurology and Psychology, Tongji Hospital, Huazhong University of Science and Technology

Bell's palsy

psychological stress

personality factors

psychological factors

Additional relevant MeSH terms:

Bell Palsy

Facial Paralysis

Paralysis

Study Results

No Results Posted as of Nov 8, 2011