Mindfulness Meditation to Improve Patient Satisfaction and Post-operative Outcomes in Rhinoplasty Patients: 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
- Change in Patient Satisfaction with patient's Nose as measured by the FACE-Q Satisfaction with Nose Scale
研究概览
简要总结
A key factor in determining success of facial plastic plastic surgery is overall patient satisfaction. While a number of patient-reported outcomes tools has been developed, there is still limited research in how physicians can improve patient satisfaction and post-operative outcomes.
The goal of this study is to investigate the effect of a mindfulness meditation phone application on rhinoplasty outcomes. This study will also explore whether mindfulness meditation is a feasible adjunct to current pharmacological modalities of postoperative pain control as well as its potential impact on patient satisfaction. These questions will be answered using a randomized controlled trial.
详细描述
The field of facial plastic surgery continues to grow as evidenced by the increasing number of services sought by both men and women each year. Among these procedures, rhinoplasty remains one of the most popular surgeries, ranking in the top three most performed cosmetic surgical procedures according to the 2017 Plastic Surgery Statistics Report. A key factor in determining the success of rhinoplasty is overall patient satisfaction. Although many patient-reported outcomes tools have been developed in this space, there is a paucity of research aimed at understanding how physicians can improve patient satisfaction in this patient population. Moreover, strategies to address the psychologic and coping ability for patients undergoing facial plastic surgery have not been investigated. To better provide patient-centered care, physicians should seek to understand the psychosocial impact of perceived nasal deformity and identify patients who may benefit from additional support interventions to complement current rhinoplasty 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 18 years of age or older
- •Patients who will undergo rhinoplasty
- •Patients with access to a smart-phone
排除标准
- •Patients younger than 18 years of age
- •Non-English speakers
- •Patients without smart-phone access
结局指标
主要结局
Change in Patient Satisfaction with patient's Nose as measured by the FACE-Q Satisfaction with Nose Scale
时间窗: Baseline (prior to intervention), postoperatively at 2 weeks and 4 weeks
FACE-Q Satisfaction with Nose scale is a 10-item questionnaire with minimum score 10, maximum score 40 assessing patient satisfaction with patient's nose; each item on the questionnaire can be answered between a range of 1 (very dissatisfied) to 4 (very satisfied) with higher scores indicating greater satisfaction with patient's nose
Change in Patient Satisfaction with patient's Nose as measured by the Rhinoplasty Outcome Evaluation scale
时间窗: Baseline (prior to intervention), postoperatively at 2 weeks and 4 weeks
Rhinoplasty Outcome Evaluation scale is a 6-item questionnaire with minimum score of 0 and maximum score of 24 assessing patient satisfaction with patient's nose; each item on the questionnaire can be answered between a range of 0 to 4 regarding statements related to patient's nose with higher scores indicating greater satisfaction with patient's nose
次要结局
- Change in Mindfulness as measured by the Cognitive and Affective Mindfulness Scale-Revised(Baseline (prior to intervention), 2 weeks, 4 weeks)
- Patient Satisfaction with Doctor as measured by FACE-Q Satisfaction with Doctor Scale(Postoperatively at 4 weeks)
- Pain Control as measured by Prescription Analgesic Use(Single measure postoperatively at routine follow-up appointment up to 1 month post procedure)
- Pain as measured by Visual Analog Scale(Postoperatively at day 2, 2 weeks and 4 weeks)
- Change in Anxiety as measured by the State-Trait Anxiety Inventory(Baseline (prior to intervention), 2 weeks, 4 weeks)
- Early Postoperative Symptoms as measured by FACE-Q Recovery Early Symptoms Scale(Postoperatively at day 2)
- Screen for Body Dysmorphic Disorder as measured by the Body Dysmorphic Disorder Questionnaire(Baseline (prior to intervention))