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NCT Number: NCT07127016

Mindfulness in Nonflaccid Facial Paralysis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location contact

Joann Bluj, MD

CONTACT

[email protected]

570-952-4527

About this study

This study will utilize a prospective randomized two-arm intervention design to assess the effects of mindfulness on patients with non-flaccid facial paralysis. Patients will either be randomized to the normal standard of care Physical Therapy intervention for 8 weeks, or Physical therapy and 8 sessions of mindfulness for 8 weeks. The patients randomized to the mindfulness intervention will undergo 8 sessions of mindfulness prior to completing their physical therapy session. These mindfulness interventions will be recordings administered through a phone or computer, through mindfulsynkinesis.com. Mindfulness scripts were created using Open Network materials and verified by a medical doctor and physical therapist trained in Mindfulness Based Stress Reduction. Each mindfulness session will take 5-10 minutes and will be completed once weekly, immediately prior to their physical therapy sessions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

No Mindfulness Sessions

Behavioral

Standard of care physical therapy without mindfulness sessions.

Primary outcomes

  1. Facial Clinimetric Evaluation Scale (FaCE)

    Time frame: Baseline

    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).

  2. Facial Clinimetric Evaluation Scale (FaCE)

    Time frame: Week 8

    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).

  3. Facial Clinimetric Evaluation Scale (FaCE)

    Time frame: Week 16

    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).

  4. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline

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

  5. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Week 8

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

  6. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Week 16

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

  7. Synkinesis Assessment Questionnaire (SAQ)

    Time frame: Baseline

    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.

  8. Synkinesis Assessment Questionnaire (SAQ)

    Time frame: Week 8

    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.

  9. Synkinesis Assessment Questionnaire (SAQ)

    Time frame: Week 16

    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.

  10. Mindfulness Attention Awareness Scale (MAAS)

    Time frame: Baseline

    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."

  11. Mindfulness Attention Awareness Scale (MAAS)

    Time frame: Week 8

    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."

  12. Mindfulness Attention Awareness Scale (MAAS)

    Time frame: Week 16

    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."

Study contacts

Contact information is provided by the study sponsor or research team.

Joann Bluj, MD

CONTACT

[email protected]

570-952-4527

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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