CClinicalTrials.gg
Status unknownNCT01377766Updated Nov 8, 2011

The Relationship Between Psychological Factors and Bell's Palsy

An observational study in Bell's Palsy, sponsored by Huazhong University of Science and Technology. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-08.

Sponsored by Huazhong University of Science and Technology · Observational

The sponsor has not verified this record recently (last verified Nov 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
800
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bell's Palsy

Keywords

  • Bell's palsy
  • psychological stress
  • personality factors
  • psychological factors
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In context

Bell Palsy

120 studies on the registry are indexed under Bell Palsy; 38 are open to participants now.

This study's planned enrollment of 800 is above the median of 75 across 24 observational studies indexed under Bell Palsy.

Browse Bell Palsy studies →

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
800 participants (estimated)
06

What researchers measure

Primary outcomes

  1. House-Brackmann scale (HBS)

    Time frame: within 168 hours after onset of symptoms

07

Study locations

1 of 1 sites recruiting
  • Institute of Integrated Traditional Chinese and Western Medicine
    Wuhan, Hubei, China
    • Guangying Huang, doctor · Contact · Gyhuang@tjh.tjmu.edu.cn · 86-027-8366-3266
    • 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 · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01377766
Lead sponsor
Huazhong University of Science and Technology
Collaborators
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
Responsible party
Wei Wang (Department of Neurology and Psychology, Tongji Hospital, Huazhong University of Science and Technology) — Principal investigator
First posted
Jun 21, 2011
Start date
Oct 2008
Primary completion
Oct 2010
Completion
Nov 2011 (estimated)
Last update
Nov 8, 2011

Study contacts

Wei Wang, doctor
Contact
wwang_tjh@126.com
86-027-8366-3648
Wei Wang, doctor
principal investigator · Tongji Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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