Mindfulness Meditation to Improve Social Functioning and Quality of Life in Patients With Facial Paralysis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Changes in Social Functioning as assessed by University of California, Los Angeles 3-point loneliness scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years of age
- •Must have any-cause facial paralysis
排除标准
- •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
结局指标
主要结局
Changes in Social Functioning as assessed by University of California, Los Angeles 3-point loneliness scale
时间窗: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
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
Changes in Social Functioning as assessed by Facial Disability Index
时间窗: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
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
Changes in Social Functioning as assessed by a Social Functioning Visual Analog Scale
时间窗: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
Social functioning visual analog scale - single-item questionnaire ranging from 0 to 100 with greater numbers indicating more comfort in socializing with others
次要结局
- Changes in Reported Quality of Life as assessed by a Visual Analog Scale(Change from baseline at 2 weeks, 4 weeks, and 6 weeks)
- Changes in Physical Functioning as assessed by Facial Disability Index(Change from baseline at 2 weeks, 4 weeks, 6 weeks)
- Changes in Mindfulness as measured using the Cognitive and Affective Mindfulness Scale-Revised(Change from baseline at 2 weeks, 4 weeks, 6 weeks)
- Changes in Anxiety assessed by the State-Trait Anxiety Inventory(Change from baseline at 2 weeks, 4 weeks, 6 weeks)