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Not yet recruitingNCT07511140FNP-PsyUpdated Apr 9, 2026

Relationship Between Facial Palsy and Psychological Distress

An observational study in Facial Palsy, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by Cairo University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
85
Ages
25 Years to 50 Years
Sex
All
01

Study 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.

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)
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.

02

Conditions studied

  • 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)
03

In context

Facial Paralysis

81 studies on the registry are indexed under Facial Paralysis; 28 are open to participants now.

This study's planned enrollment of 85 is close to the median of 80 across 21 observational studies indexed under Facial Paralysis.

Browse Facial Paralysis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (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.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
85 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: Baseline

07

Study locations

1 site
  • Faculty of Physical Therapy at Horus University-Egypt
    Damietta, 8027101, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07511140
Lead sponsor
Cairo University
Responsible party
Hadi Ahmed Salman (Teaching Assistant, Cairo University) — Principal investigator
First posted
Apr 6, 2026
Start date
Apr 15, 2026 (estimated)
Primary completion
Jul 15, 2026 (estimated)
Completion
Jul 28, 2026 (estimated)
Last update
Apr 9, 2026

Study contacts

Hadi Ahmed Salman, bachelor degree
Contact
Hsalman@horus.edu.eg
+201129727397

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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