Mindfulness in Nonflaccid Facial Paralysis

NCT07127016 | Not Yet Recruiting

• 1 other identifier: IRB00126997
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about how mindfulness techniques can help reduce anxiety, depression and body image disturbance as well as improve synkinesis in individuals with non-flaccid facial paralysis.

Conditions

Facial Paralysis

Keywords

non-flaccid facial paralysis; synkinesis; mindfulness

Outcome Measures

Primary Outcomes (12)

• Facial Clinimetric Evaluation Scale (FaCE)

  15 items rated on a 5-point Likert scale where 1 corresponds to the lowest level of function and 5 corresponds to the highest level of function. The items are categorized into 6 domains: facial movement, facial comfort, oral function, eye comfort, lacrimal control and social function with each domain being scored out of a total of 100 where 0 is the worst possible score to 100 being the best. The mean derived from all domains will determine the total score (out of 100).

  Baseline

• Facial Clinimetric Evaluation Scale (FaCE)

  15 items rated on a 5-point Likert scale where 1 corresponds to the lowest level of function and 5 corresponds to the highest level of function. The items are categorized into 6 domains: facial movement, facial comfort, oral function, eye comfort, lacrimal control and social function with each domain being scored out of a total of 100 where 0 is the worst possible score to 100 being the best. The mean derived from all domains will determine the total score (out of 100).

  Week 8

• Facial Clinimetric Evaluation Scale (FaCE)

  15 items rated on a 5-point Likert scale where 1 corresponds to the lowest level of function and 5 corresponds to the highest level of function. The items are categorized into 6 domains: facial movement, facial comfort, oral function, eye comfort, lacrimal control and social function with each domain being scored out of a total of 100 where 0 is the worst possible score to 100 being the best. The mean derived from all domains will determine the total score (out of 100).

  Week 16

• Hospital Anxiety and Depression Scale (HADS)

  14-item questionnaire measuring anxiety and depression levels. Total score range is 0-21 with higher score indicating higher likelihood of anxiety/depression.

  Baseline

• Hospital Anxiety and Depression Scale (HADS)

  14-item questionnaire measuring anxiety and depression levels. Total score range is 0-21 with higher score indicating higher likelihood of anxiety/depression.

  Week 8

• Hospital Anxiety and Depression Scale (HADS)

  14-item questionnaire measuring anxiety and depression levels. Total score range is 0-21 with higher score indicating higher likelihood of anxiety/depression.

  Week 16

• Synkinesis Assessment Questionnaire (SAQ)

  9-item questionnaire assessing patient perceived severity of synkinesis using a five-point scale. Total score ranges from 20-100. High score means a greater perceived severity of synkinesis symptoms, low score means less perceived severity of synkinesis symptoms.

  Baseline

• Synkinesis Assessment Questionnaire (SAQ)

  9-item questionnaire assessing patient perceived severity of synkinesis using a five-point scale. Total score ranges from 20-100. High score means a greater perceived severity of synkinesis symptoms, low score means less perceived severity of synkinesis symptoms.

  Week 8

• Synkinesis Assessment Questionnaire (SAQ)

  9-item questionnaire assessing patient perceived severity of synkinesis using a five-point scale. Total score ranges from 20-100. High score means a greater perceived severity of synkinesis symptoms, low score means less perceived severity of synkinesis symptoms.

  Week 16

• Mindfulness Attention Awareness Scale (MAAS)

  15-item questionnaire to assess a core characteristic of mindfulness and how much you experience mindfulness in everyday life, not just during meditation. Total score range is 15-90. High score indicates more mindful, more likely to be aware of your thoughts, feelings, and sensations in the present moment. Low score indicates less mindful, more distracted or on "automatic pilot."

  Baseline

• Mindfulness Attention Awareness Scale (MAAS)

  15-item questionnaire to assess a core characteristic of mindfulness and how much you experience mindfulness in everyday life, not just during meditation. Total score range is 15-90. High score indicates more mindful, more likely to be aware of your thoughts, feelings, and sensations in the present moment. Low score indicates less mindful, more distracted or on "automatic pilot."

  Week 8

• Mindfulness Attention Awareness Scale (MAAS)

  15-item questionnaire to assess a core characteristic of mindfulness and how much you experience mindfulness in everyday life, not just during meditation. Total score range is 15-90. High score indicates more mindful, more likely to be aware of your thoughts, feelings, and sensations in the present moment. Low score indicates less mindful, more distracted or on "automatic pilot."

  Week 16

Study Arms (2)

Mindfulness Sessions

EXPERIMENTAL

8 sessions of mindfulness prior to completing their physical therapy session

Behavioral: Mindfulness Sessions

No Mindfulness Sessions

ACTIVE COMPARATOR

Standard of care no mindfulness sessions

Behavioral: No Mindfulness Sessions

Interventions

Mindfulness Sessions BEHAVIORAL

8 sessions of mindfulness prior to completing their physical therapy session. Each mindfulness session will take 5-10 minutes and will be completed once weekly, immediately prior to their physical therapy sessions. Mindfulness prompts will focus on self-reflection, relaxation, body scanning and being present.

Mindfulness Sessions

No Mindfulness Sessions BEHAVIORAL

Standard of care physical therapy without mindfulness sessions.

No Mindfulness Sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Diagnosed with non-flaccid facial paralysis (NFFP) due to Bell's Palsy, Ramsay Hunt syndrome, Lyme disease, or post-acoustic neuroma resection, at least 8 months from the initial diagnosis

You may not qualify if:

• Received treatments such as botox or physical therapy for facial paralysis
• History of malignancy or facial surgery

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Facial Paralysis; Synkinesis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias

Study Officials

• Katherine Gossett, MD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joann Bluj, MD

CONTACT

570-952-4527; joann.bluj@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)