Preoperative Mindfulness Meditation for Total Knee Arthroplasty: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall mental health score
研究概览
简要总结
The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls, and if a preop mindfulness meditation intervention can train resilience. The main questions it aims to answer are:
- Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery?
- Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study?
- Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls? Can preoperative a mindfulness meditation intervention train resilience (as measured by increased resilience score)?
Participants will be randomly assigned to be in the intervention group or the waitlist control group. The intervention group gets the mindfulness mediation intervention prior to their day of surgery, and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery.
The waitlist control group allows for comparison between those who got the mindfulness meditation intervention prior to surgery and those who did not while still offering the potential benefits of the intervention after 90 days.
详细描述
This study will investigate the effect of a preoperative mindfulness meditation intervention (MMI) on outcomes for total knee arthroplasty (TKA) patients at the Hospital for Special Surgery in a randomized controlled trial. Mindfulness meditation is a practice well-known to psychology research based on sustained attention on the present and a non-judgment of one's current situation. It has been used for numerous psychological issues including stress, anxiety, and depression. This intervention group will be compared against a waitlist control group (patients will be told they are on a waitlist to receive the mindfulness intervention, which will occur after data collection has finished for their group). This control has been utilized in several mindfulness meditation studies.
Measures of anxiety, depression, resilience, pain and pain unpleasantness, and overall physical and mental health will be taken after randomization, but before the intervention (or being told they are on the waitlist). Overall physical and mental health measures will also be taken on the day of surgery and final surveys will be collected at 90 days post-op.
The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls, and if a preop mindfulness meditation intervention can train resilience. The main questions it aims to answer are:
- Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery?
- Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study?
- Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls? Can preoperative a mindfulness meditation intervention train resilience (as measured by increased resilience score)?
Participants will be randomly assigned to be in the intervention group or the waitlist control group. The intervention group gets the mindfulness mediation intervention prior to their day of surgery, and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Patients, research assistants, surgeons, and anesthesiologists are all unblinded
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
- •Adult patients undergoing primary total knee arthroplasty with a participating surgeon
- •Patients on these medications for anxiety/depression: Fluoxetine, Paroxetine, Citalopram, Escitalopram, Sertraline, Fluvoxamine, Venlafaxine, Duloxetine, Levomilnacipran, Desvenlafaxine, Bupropion, Mirtazapine, Amitriptyline, Nortriptyline, Clonazepam, Alprazolam, Lorazepam, Diazepam, Oxazepam, Chlordiazepoxide
- •Patients receiving intraoperative auricular acupuncture as part of participating surgeon's preferred anesthetic care
- •Patients fluent in English
- •ASA I-III
- •BMI < 40
排除标准
- •Patient not fluent in English (inability to understand the intervention video will likely affect ability to utilize the mindfulness techniques taught)
- •Pediatric patients < 18 years of age
- •Patients with contraindications to intra-op protocol
- •Patients with contraindications to auricular acupuncture (non-native ear, active ear infection, gauges in the ears)
- •Patients unable/unwilling to participate in the questionnaires or view the scripted intervention
- •Patients scheduled for consecutive or staged surgeries
- •Patients allergic to local anesthetics or study medications
- •Patients who have kidney disease
研究组 & 干预措施
Waitlist control: Receive MMI After 90 days
The waitlist control group will allow for comparison of those who had access to the mindfulness meditation intervention (MMI) prior to surgery to those who did not. This group will be given the mindfulness meditation intervention 90 days after their surgery when all study questionnaires are complete. Up until 90-days, they will be asked the same questionnaires as the intervention group aside from the MMI practice survey and the exit survey. They will then be given the exit survey 2 weeks after receiving the MMI. This is done to ensure that both groups receive the potential benefit of the teachings and to deter patient dropout for those interested in the study because of wanting to receive the mindfulness training.
干预措施: Mindfulness Meditation Intervention (Other)
Intervention: Receive MMI before their day of surgery
The intervention group will be given the mindfulness meditation intervention (MMI) 1 week prior to their day of surgery. Up until 90-days, they will be asked the same questionnaires as the waitlist control group, with the addition of the MMI practice survey and the exit survey.
干预措施: Mindfulness Meditation Intervention (Other)
结局指标
主要结局
Overall mental health score
时间窗: 1 week prior to surgery to post operative day 90
PROMIS Mental Health Questionnaire is to assess general mental health in patients 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questionsare excellent, very good, good, fair, or poor.
Anxiety
时间窗: 1 week prior to surgery to post operative day 90
Generalized Anxiety Disorder Assessment (GAD-7) is used to assess severe anxiety in patients 1 Week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are not at all sure, several days, over half the days, or nearly every day.
Exit Survey
时间窗: pre-operative holding to post-operative day 90
The exit survey is used to assess ease and helpfulness of the mindfulness meditation intervention to the patients. This is asked to the intervention group in pre-operative holding, post-operative day 14 and post-operative day 90. This survey includes several different respnses to its questions. Responses include; open ended responses; yes or no; \< 1 week, 1-2 weeks, 3-4 weeks, or 4+ weeks.
Depression
时间窗: 1 week prior to surgery to post operative day 90
The Patient Health Questionnaire (PHQ-9) is to assess depression in patients 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are not at all, Several days, more than half the days, and nearly every day.
Overall physical health scores
时间窗: 1 week prior to surgery to post operative day 90
PROMIS Physical Health Questionnaire is used to assess general physical health in patients 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are excellent, very good, good, fair, or poor.
Knee health
时间窗: 1 week prior to surgery to pre operative holding
The KOOS-JR questionnaire will assess knee health after a total knee replacement surgery 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are none, mild, moderate, severe, or extreme.
MMI Practice Survey
时间窗: pre-operative holding to post-operative day 90
The mindfulness meditation intervention practice survey helps to assess enrollment, retention, intervention completion and use measured by time to full enrollment, dropout number/proportion, number of MMI views/uses. The MMI practice survey is asked to the intervention group in pre-operative holding, post-operative day 14 and post-operative day 90. There are several different responses to these questions. These responses include yes or no; from 1-5+; emotional destress or physical pain; Not at all, somewhat improved, improved, or greatly improved.
次要结局
- Pain outcomes of patients(1 week prior to surgery to post operative day 90)
- Numerical Rating Scale (NRS)(1 week prior to surgery to post operative day 90)
- Resilience training(1 week prior to surgery to post operative day 90)
- Patient satisfaction(Post operative day 14)
- Pain catastrophizing scale(1 week prior to surgery)