Rise With Resilience
- Conditions
- Athletic InjuriesSport Injuries
- Registration Number
- NCT07217275
- Lead Sponsor
- Emory University
- Brief Summary
The objective of this study is to investigate the 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 NCAA athletes annually. For many, these injuries can be season-ending, which can exacerbate 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.)
- Individuals unable to provide consent
- Undergoing revision procedures
- Individuals without access to an internet-connected device.
- Unable to speak English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 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 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) 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.
- Secondary Outcome Measures
Name Time Method Mindful Attention Awareness Scale (MAAS) Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery) The MAAS is a validated 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present. Each item is rated on a 6-point Likert scale (1 = Almost Always, 6 = Almost Never). The mean or total score is calculated, with higher scores indicating greater mindfulness (i.e., more awareness and attention to the present moment), and lower scores indicating more automatic or distracted behavior.
Connor-Davidson Resilience Scale Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery) The Connor-Davidson Resilience Scale (CD-RISC Scale) assesses the ability to recover or bounce back after a stressful event has occurred. The abbreviated version of this scale, CD-RISC2, uses two questions from the original CD-RISC scale that capture the essence of what resilience is. Question 1, which asks if the respondent is "Able to adapt to change," and question 8, which asks the respondent if they "Tend to bounce back after illness or hardship," are used in this 2-item abbreviated measure. Range: 0-8 (Each item scored 0 = not true at all to 4 = true nearly all the time.)The abbreviated nature of this scale allows for a quick, valid, and reliable measure of a respondent's self-perceived resilience in the face of a potentially stressful event such as orthopedic surgery. Scoring: Sum the two items. Higher scores = greater resilience. Example: 0-2 = very low resilience; 7-8 = very high resilience.
Injury-Psychological Readiness to Return to Sport scale (I-PRRS) Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery) This 10-item scale is used to assess mental readiness, asking questions about confidence to play, ability to give 100% effort, and confidence in the ability to be successful upon return to play. Response format: 0-10 Likert scale 90 = Not at all confident/ready and 10 = Very confident/completely ready). Each item asks how confident the athlete feels about aspects such as: Performing at their pre-injury level, coping with pain, re-injury fears, trust in the injured body part, and overall readiness to return. Scoring range: 0-100, with higher scores indicating greater psychological readiness to return to sport and lower scores = more anxiety, doubt, or lack of confidence
Resilience Scale for Adults Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery) This 33-item scale aims to characterize a respondent's resilience in several contexts and provides a scale ranging from extremely positive outlooks to extremely negative. For example, in response to being asked "in difficult times, my family…", a scale ranging from "keeps a positive outlook on the future" to "views the future as gloomy" is provided to respondents. The breadth of question types included in this resilience scale makes it a comprehensive evaluation of an athlete's ability to respond in times of struggle. Range: 33-231, with each item scored 1-7. Scoring: Mean or total score. Higher scores indicate a greater resilience (stronger protective factors and adaptability), and lower scores indicate lower resilience or more vulnerability to stress.
ACL-Return to Sport after Injury (ACL-RSI) scale Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery) This 12-item questionnaire asks questions regarding an athlete's emotions, confidence in performance, and appraisal of risk specifically related to knee injury. While this scale has been used exclusively for evaluation of an athlete's return to sport in response to knee injury, it has application to all orthopedic related sports injuries that require surgical intervention. Some questions include: Are you nervous about playing your sport? Do you feel relaxed about playing your sport? Are you afraid of accidentally injuring your knee by playing your sport? Are you confident that you can perform at your previous level of sport participation? Do thoughts of having to go through surgery and rehabilitation again prevent you from playing your sport? Scoring extremely low demonstrates significantly worse return to play outcomes.
Actigraphy based sleep data Baseline (pre-surgery) and 2 weeks (post-surgery) The sleep data will be computed using the Cole-Kripke algorithm, which accurately distinguishes sleep from wakefulness approximately 88% of the time. Participants will receive a screenless actigraphy device and will be trained on how to wear it on their wrist. Higher sleep values indicate better or longer sleep.
Actigraphy based physical activity intensity Baseline (pre-surgery) and 2 weeks (post-surgery) Physical activity intensity will be captured using wrist actigraphy. Participants will receive a screenless actigraphy device and will be trained on how to wear it on their wrist. More frequent periods of higher intensity indicate improved activity.
Actigraphy based activity time Baseline (pre-surgery) and 2 weeks (post-surgery) Activity time will be captured using wrist actigraphy. Participants will receive a screenless actigraphy device and will be trained on how to wear it on their wrist. Longer duration indicates more time spent actively.
Actigraphy based activity (steps) Baseline (pre-surgery) and 2 weeks (post-surgery) Steps will be captured using wrist actigraphy. Participants will receive a screenless actigraphy device and will be trained on how to wear it on their wrist. More steps per day indicate greater physical activity.
Trial Locations
- Locations (1)
Emory Orthopaedics and Spine Center
🇺🇸Atlanta, Georgia, United States
Emory Orthopaedics and Spine Center🇺🇸Atlanta, Georgia, United States