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The Relationship Between Psychological Factors and Bell's Palsy

NCT ID: NCT01377766

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bell's Palsy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hubei Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Wuhan No.1 Hospital

OTHER

Sponsor Role collaborator

Xiangyang No.1 People's Hospital

OTHER

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Yichang Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

The First Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Wuhan General Hospital of Guangzhou Military Command

OTHER

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Wei Wang

Department of Neurology and Psychology, Tongji Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Wang, doctor

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Institute of Integrated Traditional Chinese and Western Medicine

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Wang, doctor

Role: CONTACT

[email protected]
86-027-8366-3648

Facility Contacts

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Guangying Huang, doctor

Role: primary

[email protected]
86-027-8366-3266

Other Identifiers

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2006CB504502-3

Identifier Type: -

Identifier Source: org_study_id