Rise With Resilience
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-26
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.)
Disqualifiers
Individuals unable to provide consent
Undergoing revision procedures
Individuals without access to an internet-connected device.
Unable to speak English
Trial design
Design model
Parallel
Treatments tested in this trial
Community Resiliency Model (CRM)
Other interventionCRM 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®. Participants will be randomized to work with a mindfulness specialist at the baseline visit for 90 minutes and at follow-up visits for 15-30 minutes over Zoom®. The team's mindfulness specialists will deliver the evidence-based mindfulness training.
Control
Other interventionParticipants 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 minimally enhanced usual care attention-based control group design has been successfully utilized in other trials to mitigate biases and dropouts.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Community Resiliency Model (CRM)Experimental treatment 1 intervention
Group B: Standard of Care (SOC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
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.
Time frame
Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)2
Opioid utilization
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.
Time frame
Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)3
Pain numerical rating scale (NRS)
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.
Time frame
Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)Secondary outcomes
1
Mindful Attention Awareness Scale (MAAS)
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.
Time frame
Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)2
Connor-Davidson Resilience Scale (CD-RISC)
The Connor-Davidson (CD) Resilience Scale (RISC) assesses the ability to recover from a stressful event. The abbreviated version of this scale, CD-RISC-2, uses two questions from the original CD-RISC that capture the essence of resilience. Question 1, which asks if the respondent is "Able to adapt to change," and question 8, which asks the respondent whether 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.
Time frame
Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)3
Injury-Psychological Readiness to Return to Sport scale (I-PRRS)
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
Time frame
Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)4
Resilience Scale for Adults
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.
Time frame
Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Collegiate Athletic Association - NCAA
Collaborator
Source ClinicalTrials.gov