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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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.
Johns Hopkins Hospital
Baltimore, Maryland, United States
Johns Hopkins - Green Spring Station
Lutherville-Timonium, Maryland, United States
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
Time frame: 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
Time frame: 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
Time frame: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
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)
Time frame: 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)
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Time frame: 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
Time frame: 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
Time frame: Change from baseline at 2 weeks, 4 weeks, 6 weeks