Bell's PalsyNCT01377766
The Relationship Between Psychological Factors and Bell's Palsy
An observational study of Bell's Palsy, run by Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bell's Palsy
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 695 subjects were assigned to Cases Group (n=355) and Control Group (n=340).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Integrated Traditional Chinese and Western Medicine
Wuhan, Hubei
Guangying Huang, doctor, 86-027-8366-3266, Gyhuang@tjh.tjmu.edu.cn
Ling Liu, Doctor
About this study
Official title: 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.
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.
- Conditions
- Bell's Palsy
- Keywords
- Bell's palsy, psychological stress, personality factors, psychological factors
- Medical subject headings
- Bell Palsy, Stress, Psychological
What is being measured
The primary outcome is the main question the study is designed to answer.
House-Brackmann scale (HBS)
Measured: within 168 hours after onset of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startOct 2008
- Primary completionOct 2010
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell's PalsyStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Wei Wang, Huazhong University of Science and Technology
- Investigators
- Wei Wang, doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377766
- Sponsor's protocol ID
- 2006CB504502-3
- Status last verified
- Nov 2011
- First submitted
- 20 Jun 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Psychological Factors on the Occurence of Bell's Palsy
- ClinicalTrials.gov ID
- NCT01377766
- Acronym / sponsor ID
- 2006CB504502-3
- Conditions
- Bell's Palsy
- Keywords
- Bell's palsy, psychological stress, personality factors, psychological factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- 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
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2011 (estimated)
- First posted
- 21 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 695 subjects were assigned to Cases Group (n=355) and Control Group (n=340).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
House-Brackmann scale (HBS)
Time frame: within 168 hours after onset of symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Wang, doctor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bell's Palsy, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Wang, doctor (86-027-8366-3648, wwang_tjh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
House-Brackmann scale (HBS) (time frame: within 168 hours after onset of symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.