Mindfulness in Nonflaccid Facial Paralysis
ConditionFacial Paralysis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Received treatments such as botox or physical therapy for facial paralysis
History of malignancy or facial surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness Sessions
Behavioral8 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
BehavioralStandard of care physical therapy without mindfulness sessions.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Mindfulness SessionsExperimental treatment 1 intervention
Group B: No Mindfulness SessionsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline2
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).
Time frame
Week 83
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).
Time frame
Week 164
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.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: