Facial ParalysisNCT07127016
Mindfulness in Nonflaccid Facial Paralysis
A study testing Mindfulness Sessions and No Mindfulness Sessions in people with Facial Paralysis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Paralysis
- What is being tested?
- Mindfulness Sessions and No Mindfulness Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2027to Apr 2028
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Received treatments such as botox or physical therapy for facial paralysis
- History of malignancy or facial surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Joann Bluj, MD, 570-952-4527, joann.bluj@advocatehealth.org
About this study
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.
Read the detailed description
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.
- Conditions
- Facial Paralysis
- Being tested
- Mindfulness Sessions, No Mindfulness Sessions
- Keywords
- non-flaccid facial paralysis, synkinesis, mindfulness
- Medical subject headings
- Facial Paralysis, Synkinesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness SessionsBehavioural
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 SessionsBehavioural
Standard of care physical therapy without mindfulness sessions.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Sessions | Experimental | 8 sessions of mindfulness prior to completing their physical therapy session Receives: Behavioral: Mindfulness Sessions |
| No Mindfulness Sessions | Active comparator | Standard of care no mindfulness sessions Receives: Behavioral: No Mindfulness Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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."
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study startApr 2027 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial ParalysisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Gossett, MD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127016
- Sponsor's protocol ID
- IRB00126997
- Status last verified
- Jun 2026
- First submitted
- 11 Aug 2025
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness in Nonflaccid Facial Paralysis
- ClinicalTrials.gov ID
- NCT07127016
- Acronym / sponsor ID
- IRB00126997
- Conditions
- Facial Paralysis
- Keywords
- non-flaccid facial paralysis, synkinesis, mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Apr 2027 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 17 Aug 2025 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Sessions | Experimental | Behavioral: Mindfulness Sessions8 sessions of mindfulness prior to completing their physical therapy session |
| No Mindfulness Sessions | Active comparator | Behavioral: No Mindfulness SessionsStandard of care no mindfulness sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Received treatments such as botox or physical therapy for facial paralysis
- History of malignancy or facial surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Sessions8 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. | Behavioural | Mindfulness Sessions |
| No Mindfulness SessionsStandard of care physical therapy without mindfulness sessions. | Behavioural | No Mindfulness Sessions |
Primary outcome
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).
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).
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).
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.
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.
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.
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.
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.
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.
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."
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."
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."
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 30 Sep 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.
Katherine Gossett, MD principal investigator
Atrium Health Wake Forest Baptist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Sessions and No Mindfulness Sessions in people with Facial Paralysis, run by Wake Forest University Health Sciences at 1 site in United States.
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 1 inclusion and 2 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 30 Sep 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 United States. 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 Joann Bluj, MD (570-952-4527, joann.bluj@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Clinimetric Evaluation Scale (FaCE) (time frame: Baseline). The study lists 12 primary outcomes in all. 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 30 Sep 2026.