Effects of Mindfulness Meditation on Facial Paralysis Patients

Study Overview
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Brief Summary
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Currently, physicians have several options in addressing the anatomic and physiologic sequela of facial paralysis. However, strategies to address the psychologic and coping ability for patients have not been investigated. The goal is to investigate the effect of mindfulness meditation on social functioning in patients with facial paralysis. This study will also explore whether increasing social functioning in patients with facial paralysis will improve overall quality of life. These questions will be answered using a randomized controlled trial.

Detailed Description
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In this study population, facial paralysis was significantly associated with increased loneliness, decreased social function, decreased comfort with socializing, and worse quality of life scores. Furthermore, prior studies have shown that facial paralysis increases the likelihood of depression as measured on validated psychometric instruments. Currently, treating physicians have several options in addressing the anatomic and physiologic sequela of facial paralysis. However, strategies to address the psychologic and coping ability for patients have not been investigated. To better provide patient-centered care, physicians should consider the psychosocial impact of facial paralysis to identify patients who may benefit from additional support interventions to complement facial reanimation treatment plans. This is a prospective repeated measures study examining psychosocial status as measured by validated psychometric instruments. The intervention group will participate in mindfulness meditation using a phone application. Assessment of social functioning and quality of life will be conducted using survey instruments.

Official Title
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Mindfulness Meditation to Improve Social Functioning and Quality of Life in Patients With Facial Paralysis: A Randomized Controlled Trial

Conditions
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Facial Paralysis

Intervention / Treatment
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* Behavioral: Mindfulness Meditation Phone Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years of age Must have any-cause facial paralysis Exclusion Criteria: Patients younger than 18 years old Non-English speakers Patients without smart-phone access Patients with autism Patients with schizophrenia Patients with an affective psychiatric condition

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Meditation Arm<br>Mindfulness meditation intervention: patients will be asked to complete a guided mindfulness meditation phone application intervention. | Behavioral: Mindfulness Meditation Phone Application<br>* Mindfulness meditation intervention: patients will be asked to complete a guided mindfulness meditation intervention using a phone application for at least 4 weeks with periodic survey assessments using validated psychometric tools.<br>|
| No Intervention: Non-Intervention Arm<br>Patients assigned to the non-intervention arm will not be instructed to use a mindfulness meditation phone application and instead will listen to educational materials. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Social Functioning as assessed by University of California, Los Angeles 3-point loneliness scale | University of California, Los Angeles 3-point loneliness scale - minimum score 0, maximum score 100 assessing how often one feels socially isolated, higher indicating greater loneliness | Change from baseline at 2 weeks, 4 weeks, and 6 weeks | 
| Changes in Social Functioning as assessed by Facial Disability Index | Facial disability index (social functioning portion) - categorical responses ranging from never to all of the time for social problems associated with facial muscle function over the past month to measure social functioning; the minimum to maximum score range for social functioning is 5 to 30 with a higher score indicating greater social functioning | Change from baseline at 2 weeks, 4 weeks, and 6 weeks | 
| Changes in Social Functioning as assessed by a Social Functioning Visual Analog Scale | Social functioning visual analog scale - single-item questionnaire ranging from 0 to 100 with greater numbers indicating more comfort in socializing with others | Change from baseline at 2 weeks, 4 weeks, and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Reported Quality of Life as assessed by a Visual Analog Scale | Quality of life will be measured using the validated quality of life visual analog scale (single-item questionnaire ranging from 0 to 100 with greater numbers indicating a higher quality of life) | Change from baseline at 2 weeks, 4 weeks, and 6 weeks | 
| Changes in Anxiety assessed by the State-Trait Anxiety Inventory | Anxiety will be measured using the validated State-Trait Anxiety Inventory with 20 items measuring trait anxiety and 20 items measuring state anxiety, each with categorical responses ranging from never to very much so in response statements regarding how one feels generally (trait) and at the current moment (state) | Change from baseline at 2 weeks, 4 weeks, 6 weeks | 
| Changes in Mindfulness as measured using the Cognitive and Affective Mindfulness Scale-Revised | Mindfulness will be measured using the validated Cognitive and Affective Mindfulness Scale-Revised which is a 12-item questionnaire with categorical responses ranging rarely/not at all to almost always regarding statements about one's experience of mindfulness with minimum score of 12 points to a maximum score of 48 points where a higher score indicates greater mindful qualities | Change from baseline at 2 weeks, 4 weeks, 6 weeks | 
| Changes in Physical Functioning as assessed by Facial Disability Index | Facial disability index (physical functioning portion) - categorical responses ranging from usually with no difficulty to usually did not do because of health for physical problems associated with facial muscle function over the past month to measure physical functioning; the minimum to maximum score range for social functioning is 0 to 25 with a higher score indicating worse physical function | Change from baseline at 2 weeks, 4 weeks, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, meditation, facial paralysis, quality of life, social functioning