Rise With Resilience: A Clinical Trial Examining Mindfulness Training for Enhancing Recovery in Injured Student-Athletes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
研究概览
简要总结
The objective of this study is to investigate differences in postoperative pain, physical health, and mental health outcomes between participants receiving evidence-based mindfulness training and those who do not.
Over 200,000 injuries are estimated to occur among National Collegiate Athletic Association (NCAA) athletes annually. For many, these injuries can be season-ending, exacerbating physical, mental, and social well-being. Student-athletes face distinctive challenges compared to traditional students, such as balancing academic and athletic demands, pressures to perform well on and off the field, and the physical demands of competition, all of which can lead to worse mental and emotional outcomes if not properly managed. Injuries heighten stress levels among athletes, remove them from competition, and force students to integrate treatment regimens into already packed academic schedules.
详细描述
In this study, researchers will investigate how student-athletes can enhance their recovery following surgery for an injury by incorporating mindfulness-based practices.
Athletic performance, physical output, and overall wellness have been shown to improve when athletes incorporate evidence-based mindfulness and cognitive skills. Yet, minimal research has examined how cognitive and mindfulness skills can be leveraged specifically by injured student athletes to facilitate return to play, mitigate stress, and support academic performance following surgery. This randomized clinical trial will recruit college athletes undergoing surgery due to injury and randomize them to work with an expert on implementing skills from the Community Resiliency Model® (CRM).
Over the span of three months after surgery, the interdisciplinary research team will compare patient-reported outcomes and objective recovery measures from wrist-worn actigraphy devices to determine the impact of educating athletes on incorporating CRM skills that enhance well-being following surgery, compared to standard of care (SOC) written discharge instructions. Participants will complete questionnaires in person and/or via email about their general health and their pain at each appointment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •College student athletes 18-26 years old,
- •Scheduled for orthopedic surgery due to sports medicine injuries (e.g., anterior cruciate ligament tears, meniscus injury, rotator cuff injury, etc.)
排除标准
- •Individuals unable to provide consent
- •Undergoing revision procedures
- •Individuals without access to an internet-connected device.
- •Unable to speak English
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
时间窗: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
PROMIS Physical Function measures participants' self-reported capability to conduct physical activity. This includes capturing function in upper extremities and lower extremities (walking or mobility) as well as a respondent's ability to conduct activities of daily living. There are 4-items on the short form questionnaire and respondents report their capabilities to perform each task on a Likert scale from 5, "without any difficulty", to 1, "unable to do". All 4-items' saw scores are summed before being transformed into t-scores ranging from 0 to 100. Higher scores are better and indicate greater physical function.
Opioid utilization
时间窗: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
Inpatient and operating room opioid utilization will be extracted from the electronic health record (EHR) by study staff upon participants' discharge from the hospital. Opioid medication dosage will be transformed to a total universal measure known as morphine milligram equivalent (MME). MME will be averaged over the length-of-stay (LOS) for a daily dosage, known as MME/day. Additionally, the study team will review the participants' EHR at each study time point up to 3 months to determine MME throughout postoperative recovery and rehabilitation. Higher values indicate a greater dosage per day.
Pain numerical rating scale (NRS)
时间窗: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)
The NRS requires respondents to rate the intensity of their pain on a defined scale from 0, "no pain", to 10, 'the worst pain imaginable". The NRS is a commonly used pain assessment tool in both clinical practice and research. Higher scores indicate worse pain.
次要结局
- Actigraphy based activity (steps)(Baseline (pre-surgery) and 2 weeks (post-surgery))
- Mindful Attention Awareness Scale (MAAS)(Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery))
- Connor-Davidson Resilience Scale (CD-RISC)(Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery))
- Injury-Psychological Readiness to Return to Sport scale (I-PRRS)(Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery))
- Resilience Scale for Adults(Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery))
- ACL-Return to Sport after Injury (ACL-RSI) scale(Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery))
- Actigraphy based sleep data(Baseline (pre-surgery) and 2 weeks (post-surgery))
- Actigraphy based physical activity intensity(Baseline (pre-surgery) and 2 weeks (post-surgery))
- Actigraphy based activity time(Baseline (pre-surgery) and 2 weeks (post-surgery))
- Actigraphy based activity (steps)(Baseline (pre-surgery) and 2 weeks (post-surgery))
研究者
Nicholas A. Giordano
Assistant Professor
Emory University