Rise With Resilience

Официальное название

Rise With Resilience: A Clinical Trial Examining Mindfulness Training for Enhancing Recovery in Injured Student-Athletes

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Community Resiliency Model (CRM)
  CRM is an evidence-based mindfulness approach that provides patients with a biological perspective on behavioral health and stress reactions. CRM teaches six (6) mindfulness-based skills to address body sensation perception to attenuate symptoms of stress and anxiety, which in turn contribute to reducing pain and stress response. Trained specialists will introduce mindfulness skills to athletes, educate them on how to apply the skills, and observe athletes practicing the skills via Zoom®. Partic
• Другое Control
  Participants will receive written discharge instructions on postoperative pain management interventions given to all patients seeking care at Emory. The handout includes guidance on when to take prescribed pain medications and how to implement non-pharmacological pain management approaches, such as cryotherapy or aroma therapy. To mitigate attention biases, study staff and clinical staff will meet with control arm participants at each follow-up visit for 15-30 minutes to review the handout. This

Первичные конечные точки

• Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function [Срок оценки: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)]
• Opioid utilization [Срок оценки: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)]
• Pain numerical rating scale (NRS) [Срок оценки: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)]

Вторичные конечные точки (9)

• Mindful Attention Awareness Scale (MAAS) [Срок оценки: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)]
• Connor-Davidson Resilience Scale (CD-RISC) [Срок оценки: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)]
• Injury-Psychological Readiness to Return to Sport scale (I-PRRS) [Срок оценки: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)]
• Resilience Scale for Adults [Срок оценки: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)]
• ACL-Return to Sport after Injury (ACL-RSI) scale [Срок оценки: Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)]
• Actigraphy based sleep data [Срок оценки: Baseline (pre-surgery) and 2 weeks (post-surgery)]
• Actigraphy based physical activity intensity [Срок оценки: Baseline (pre-surgery) and 2 weeks (post-surgery)]
• Actigraphy based activity time [Срок оценки: Baseline (pre-surgery) and 2 weeks (post-surgery)]
• Actigraphy based activity (steps) [Срок оценки: Baseline (pre-surgery) and 2 weeks (post-surgery)]

Критерии участия

Критерии включения

• 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.)

Критерии исключения

• Individuals unable to provide consent
• Undergoing revision procedures
• Individuals without access to an internet-connected device.
• Unable to speak English

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Emory Orthopaedics and Spine Center — Atlanta

Идентификаторы

NCT: NCT07217275 · 2025P011851

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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