Mindfulness in Nonflaccid Facial Paralysis

Not Applicable

Not yet recruiting

• Conditions: Facial Paralysis

• Registration Number: NCT07127016
• Lead Sponsor: Wake Forest University Health Sciences

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.

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 Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-11
• Study First Posted: 2025-08-17
• Last Update Submitted: 2025-08-22
• Last Update Posted: 2025-08-24
• Study Start: 2025-09-01
• Primary Completion: 2027-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Facial Clinimetric Evaluation Scale (FaCE)	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)	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)	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)	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."

Trial Locations

Locations (1)

Atrium Health Wake Forest Baptist; 🇺🇸 Winston-Salem, North Carolina, United States