The Relationship Between Psychological Factors and Bell's Palsy

Bell's Palsy Clinical Trial

Official title:

Study of Psychological Factors on the Occurence of Bell's Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01377766
• Other study ID #: 2006CB504502-3
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2011
• Last updated: November 5, 2011
• Start date: October 2008
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Huazhong University of Science and Technology
• Contact: Wei Wang, doctor
• Phone: 86-027-8366-3648
• Email: wwang_tjh[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: November 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bell Palsy
• Bell's Palsy
• Facial Paralysis

Locations

Country	Name	City	State
China	Institute of Integrated Traditional Chinese and Western Medicine	Wuhan	Hubei

Sponsors (10)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Fudan University, Hebei Medical University First Hospital, Hubei Hospital of Traditional Chinese Medicine, Renmin Hospital of Wuhan University, Second Affiliated Hospital of Zhengzhou University, Wuhan General Hospital of Guangzhou Military Command, Wuhan No.1 Hospital, Xiangyang No.1 People's Hospital, Yichang Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	House-Brackmann scale (HBS)		within 168 hours after onset of symptoms	No