Mindfulness in Nonflaccid Facial Paralysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness Sessions, No Mindfulness Sessions.
- Who it may be relevant to
- Registry conditions: Facial Paralysis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Mindfulness Sessions
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. - Behavioral No Mindfulness Sessions
Standard of care physical therapy without mindfulness sessions.
Primary outcome measures
- Facial Clinimetric Evaluation Scale (FaCE) [Time frame: Baseline]
- Facial Clinimetric Evaluation Scale (FaCE) [Time frame: Week 8]
- Facial Clinimetric Evaluation Scale (FaCE) [Time frame: Week 16]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: Baseline]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: Week 8]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: Week 16]
- Synkinesis Assessment Questionnaire (SAQ) [Time frame: Baseline]
- Synkinesis Assessment Questionnaire (SAQ) [Time frame: Week 8]
- Synkinesis Assessment Questionnaire (SAQ) [Time frame: Week 16]
- Mindfulness Attention Awareness Scale (MAAS) [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Atrium Health Wake Forest Baptist — Winston-Salem
Identifiers
NCT: NCT07127016 · IRB00126997