Facial PalsyFNP-PsyNCT07511140
Relationship Between Facial Palsy and Psychological Distress
An observational study of Facial Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this observational cross-sectional study is to investigate whether the severity of facial dysfunction is associated with psychological distress in patients with unilateral facial palsy. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Facial Palsy
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2026to 28 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Eighty-five patients of both sexes with unilateral idiopathic Bell's palsy will be participate in this study. The patients diagnosis as having Bell's palsy based on careful clinical examination by a neurologist. The diagnosis will be confirmed by nerve conduction studies. Patients will be recruited from the outpatient clinic of the Faculty of Physical Therapy, Hours University.
Who may be able to join
- Patients with unilateral idiopathic Bell's palsy confirmed by nerve conduction studies (NCS) will be included.
- The age of patients ranged from 25 to 50 years.
- The duration of Bell's palsy ranged from three months to two years.
- Patients with a body mass index (BMI) less than 30 kg/m² will be included.
- Only patients who were able to comprehend and complete questionnaires will be included in the study.
Who cannot join
- History of recurrent facial palsy or bilateral facial nerve involvement.
- Presence of other neurological disorders unrelated to facial palsy affecting the face (e.g., stroke, multiple sclerosis).
- A current diagnosis of psychiatric illness prior to the onset of facial palsy.
- Cognitive impairment preventing valid completion of assessments.
- Sleep disorders.
- Diabetes mellitus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Physical Therapy at Horus University-Egypt
Damietta, 8027101
Horus University EGYPT, +201144455582, info@horus.edu.eg
About this study
Official title: Relationship Between Severity of Facial Nerve Dysfunction and Psychological Distress in Patients With Bell's Palsy
The goal of this observational cross-sectional study is to investigate whether the severity of facial dysfunction is associated with psychological distress in patients with unilateral facial palsy.
The main questions it aims to answer are:
Read more
- Is there a significant relationship between the degree of facial muscle dysfunction (as measured by Sunnybrook Facial Grading Scale and EMG parameters) and levels of anxiety and depression (as measured by HADS)?
- Does reduced facial function correlate with lower self-esteem levels (as measured by the Arabic version of the Single-Item Self-Esteem Scale)?
Researcher will assess and analyze the correlation between facial motor impairment and psychological outcomes to determine whether greater functional impairment is associated with increased psychological distress.
Participants will:
- Undergo clinical assessment using the Sunnybrook Facial Grading Scale to evaluate facial nerve function
- Receive electrophysiological evaluation using surface electromyography (sEMG) to measure muscle activity
- Complete standardized questionnaires including the Hospital Anxiety and Depression Scale (HADS) and the Arabic Single-Item Self-Esteem Scale (A-SISE)
Read the detailed description
Facial palsy represents a complex neurological condition with multifactorial consequences that extend beyond motor dysfunction to encompass significant psychosocial impairment. While the physical manifestations of facial nerve dysfunction are well characterized, the psychological sequelae particularly anxiety, depression, and diminished self-esteem remain under-investigated in relation to objective measures of functional severity. Existing literature has largely relied on subjective or isolated assessment approaches, with limited integration of clinical grading systems and electrophysiological quantification.
This study aims to systematically examine the association between the severity of facial dysfunction and psychological distress using a multidimensional assessment framework. Objective evaluation of facial motor function will be conducted using standardized clinical grading, complemented by electrophysiological measurements to quantify muscle activity and neuromuscular performance. Psychological outcomes will be assessed using validated instruments that capture core domains of emotional well-being, including anxiety, depressive symptoms, and global self-esteem.
Facial motor function will be assessed using the Sunnybrook Facial Grading Scale (SFGS), a validated and widely used clinical tool that evaluates resting symmetry, voluntary movement, and synkinesis. The composite score derived from this scale provides a quantitative measure of overall facial nerve function, allowing for sensitive detection of varying degrees of impairment across facial regions.
To complement clinical evaluation, electrophysiological assessment will be conducted using surface electromyography (sEMG) to objectively quantify muscle activity in key facial muscles. sEMG recordings will be obtained from standardized electrode placement sites over functionally relevant muscles (e.g., frontalis, orbicularis oculi, and orbicularis oris). Signal analysis will include parameters such as amplitude (e.g., root mean square [RMS]) to reflect motor unit recruitment and neuromuscular activation. This quantitative approach provides objective insight into the degree of muscle involvement and functional integrity, enhancing the precision of facial function assessment.
Psychological outcomes will be evaluated using validated self-report instruments. The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depressive symptoms through its two subscales, providing a reliable measure of psychological distress in clinical populations. Additionally, global self-esteem will be assessed using the Arabic version of the Single-Item Self-Esteem Scale (A-SISE), a brief yet validated measure designed to capture the individual's overall perception of self-worth.
A key strength of this study lies in its integrative design, which combines clinical, electrophysiological, and patient-reported outcome measures within a single analytical model. This approach is intended to address an existing gap in the literature regarding the extent to which objectively measured facial impairment correlates with psychological burden.
The findings of this study are expected to provide clinically relevant insights into the interplay between functional impairment and mental health in patients with facial palsy. In turn, this may contribute to improved risk stratification, early identification of vulnerable patients, and the development of comprehensive rehabilitation strategies that incorporate both physical and psychosocial dimensions of care.
- Conditions
- Facial Palsy
- Keywords
- Facial nerve palsy, Bell's palsy, facial dysfunction, psychological distress, anxiety, depression, self-esteem, Electromyography, EMG, surface electromyography (sEMG), Sunnybrook Facial Grading System, Hospital Anxiety and Depression Scale (HADS), Single-Item Self-Esteem Scale (SISE)
- Medical subject headings
- Facial Paralysis, Bell Palsy, Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional association between facial dysfunction and psychological outcomes
The primary outcome is to evaluate the association between facial dysfunction and psychological status using both clinical and electrophysiological measures. Facial motor function will be assessed using the Sunnybrook Facial Grading Scale (SFGS), while muscle activity will be quantified using surface electromyography (sEMG) (RMS amplitude). Psychological outcomes will be assessed using the Hospital Anxiety and Depression Scale (HADS) and the Arabic Single-Item Self-Esteem Scale (A-SISE).
The analysis will examine the correlations between all variables, including:
SFGS scores and HADS (anxiety and depression) SFGS scores and A-SISE sEMG (RMS) values and HADS scores sEMG (RMS) values and A-SISE
Measured: Baseline (single assessment at time of enrollment)
Secondary outcomes (1)
Agreement between clinical and electrophysiological measures of facial function
To assess the relationship between SFGS scores and sEMG RMS values in selected facial muscles, reflecting the agreement between clinical grading and objective neuromuscular activity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion28 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadi Ahmed Salman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511140
- Sponsor's protocol ID
- CU-FNP-PsychDistress-2026
- Other IDs
- P.T.REC/012/006092
- Acronym
- FNP-Psy
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Severity of Facial Nerve Dysfunction and Psychological Distress in Patients With Bell's Palsy
- ClinicalTrials.gov ID
- NCT07511140
- Acronym / sponsor ID
- FNP-Psy / CU-FNP-PsychDistress-2026
- Conditions
- Facial Palsy
- Keywords
- Facial nerve palsy, Bell's palsy, facial dysfunction, psychological distress, anxiety, depression, self-esteem, Electromyography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 28 Jul 2026 (estimated)
- First posted
- 6 Apr 2026 (actual)
- 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 goal of this observational cross-sectional study is to investigate whether the severity of facial dysfunction is associated with psychological distress in patients with unilateral facial palsy.
The main questions it aims to answer are:
- Is there a significant relationship between the degree of facial muscle dysfunction (as measured by Sunnybrook Facial Grading Scale and EMG parameters) and levels of anxiety and depression (as measured by HADS)?
- Does reduced facial function correlate with lower self-esteem levels (as measured by the Arabic version of the Single-Item Self-Esteem Scale)?
Researcher will assess and analyze the correlation between facial motor impairment and psychological outcomes to determine whether greater functional impairment is associated with increased psychological distress.
Participants will:
- Undergo clinical assessment using the Sunnybrook Facial Grading Scale to evaluate facial nerve function
- Receive electrophysiological evaluation using surface electromyography (sEMG) to measure muscle activity
- Complete standardized questionnaires including the Hospital Anxiety and Depression Scale (HADS) and the Arabic Single-Item Self-Esteem Scale (A-SISE)
Detailed description
Facial palsy represents a complex neurological condition with multifactorial consequences that extend beyond motor dysfunction to encompass significant psychosocial impairment. While the physical manifestations of facial nerve dysfunction are well characterized, the psychological sequelae particularly anxiety, depression, and diminished self-esteem remain under-investigated in relation to objective measures of functional severity. Existing literature has largely relied on subjective or isolated assessment approaches, with limited integration of clinical grading systems and electrophysiological quantification.
This study aims to systematically examine the association between the severity of facial dysfunction and psychological distress using a multidimensional assessment framework. Objective evaluation of facial motor function will be conducted using standardized clinical grading, complemented by electrophysiological measurements to quantify muscle activity and neuromuscular performance. Psychological outcomes will be assessed using validated instruments that capture core domains of emotional well-being, including anxiety, depressive symptoms, and global self-esteem.
Facial motor function will be assessed using the Sunnybrook Facial Grading Scale (SFGS), a validated and widely used clinical tool that evaluates resting symmetry, voluntary movement, and synkinesis. The composite score derived from this scale provides a quantitative measure of overall facial nerve function, allowing for sensitive detection of varying degrees of impairment across facial regions.
To complement clinical evaluation, electrophysiological assessment will be conducted using surface electromyography (sEMG) to objectively quantify muscle activity in key facial muscles. sEMG recordings will be obtained from standardized electrode placement sites over functionally relevant muscles (e.g., frontalis, orbicularis oculi, and orbicularis oris). Signal analysis will include parameters such as amplitude (e.g., root mean square [RMS]) to reflect motor unit recruitment and neuromuscular activation. This quantitative approach provides objective insight into the degree of muscle involvement and functional integrity, enhancing the precision of facial function assessment.
Psychological outcomes will be evaluated using validated self-report instruments. The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depressive symptoms through its two subscales, providing a reliable measure of psychological distress in clinical populations. Additionally, global self-esteem will be assessed using the Arabic version of the Single-Item Self-Esteem Scale (A-SISE), a brief yet validated measure designed to capture the individual's overall perception of self-worth.
A key strength of this study lies in its integrative design, which combines clinical, electrophysiological, and patient-reported outcome measures within a single analytical model. This approach is intended to address an existing gap in the literature regarding the extent to which objectively measured facial impairment correlates with psychological burden.
The findings of this study are expected to provide clinically relevant insights into the interplay between functional impairment and mental health in patients with facial palsy. In turn, this may contribute to improved risk stratification, early identification of vulnerable patients, and the development of comprehensive rehabilitation strategies that incorporate both physical and psychosocial dimensions of care.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Eighty-five patients of both sexes with unilateral idiopathic Bell's palsy will be participate in this study. The patients diagnosis as having Bell's palsy based on careful clinical examination by a neurologist. The diagnosis will be confirmed by nerve conduction studies. Patients will be recruited from the outpatient clinic of the Faculty of Physical Therapy, Hours University.
Key inclusion criteria (5 listed)
- Patients with unilateral idiopathic Bell's palsy confirmed by nerve conduction studies (NCS) will be included.
- The age of patients ranged from 25 to 50 years.
- The duration of Bell's palsy ranged from three months to two years.
- Patients with a body mass index (BMI) less than 30 kg/m² will be included.
- Only patients who were able to comprehend and complete questionnaires will be included in the study.
Key exclusion criteria (6 listed)
- History of recurrent facial palsy or bilateral facial nerve involvement.
- Presence of other neurological disorders unrelated to facial palsy affecting the face (e.g., stroke, multiple sclerosis).
- A current diagnosis of psychiatric illness prior to the onset of facial palsy.
- Cognitive impairment preventing valid completion of assessments.
- Sleep disorders.
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
Multidimensional association between facial dysfunction and psychological outcomes
Time frame: Baseline (single assessment at time of enrollment)
The primary outcome is to evaluate the association between facial dysfunction and psychological status using both clinical and electrophysiological measures. Facial motor function will be assessed using the Sunnybrook Facial Grading Scale (SFGS), while muscle activity will be quantified using surface electromyography (sEMG) (RMS amplitude). Psychological outcomes will be assessed using the Hospital Anxiety and Depression Scale (HADS) and the Arabic Single-Item Self-Esteem Scale (A-SISE). The analysis will examine the correlations between all variables, including: SFGS scores and HADS (anxiety and depression) SFGS scores and A-SISE sEMG (RMS) values and HADS scores sEMG (RMS) values and A-SISE
1 secondary outcome
Agreement between clinical and electrophysiological measures of facial function
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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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.
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 Facial Palsy, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 9 Apr 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hadi Ahmed Salman, bachelor degree (+201129727397, Hsalman@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional association between facial dysfunction and psychological outcomes (time frame: Baseline (single assessment at time of enrollment)). 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 9 Apr 2026.