Relationship Between Facial Palsy and Psychological Distress

NCT07511140 | Not Yet Recruiting

• 2 other identifiers: CU-FNP-PsychDistress-2026P.T.REC/012/006092
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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)

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)

Outcome Measures

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

  Baseline (single assessment at time of enrollment)

Secondary Outcomes (1)

• Agreement between clinical and electrophysiological measures of facial function

  Baseline

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy at Horus University-Egypt

Damietta, 8027101, Egypt

Location

MeSH Terms

Conditions

Facial Paralysis; Bell Palsy; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Facial Nerve Diseases; Cranial Nerve Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Hadi Ahmed Salman, bachelor degree

CONTACT

+201129727397; Hsalman@horus.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 28, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)