Rise With Resilience

NCT07217275 | Recruiting

• 1 other identifier: 2025P011851
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Athletic Injuries; Sport Injuries

Keywords

Orthopedic surgery; Student Athletes; Mindfulness skills

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)

• 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.

  Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)

• 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.

  Baseline (pre-surgery), 2 weeks, 6 weeks, and 3 months (post-surgery)

Secondary Outcomes (9)

• 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)

Study Arms (2)

Community Resiliency Model (CRM)

EXPERIMENTAL

Athletes randomized to the intervention will receive education before surgery. The intervention includes pairing participants with a specialist who will introduce mindfulness skills to athletes, educate them on how to apply the skills, and observe athletes practicing the skills via Zoom®.

Other: Community Resiliency Model (CRM)

Standard of Care (SOC)

ACTIVE COMPARATOR

Athletes randomized to the control group will receive standard of care, written instructions, and handouts on postoperative pain management interventions.

Other: Control

Interventions

Control OTHER

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 minimally enhanced usual care attention-based control group design has been successfully utilized in other trials to mitigate biases and dropouts.

Also known as: Standard of Care (SOC)

Standard of Care (SOC)

Community Resiliency Model (CRM) OTHER

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®. 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.

Also known as: Virtual Intervention

Community Resiliency Model (CRM)

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.)

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• National Collegiate Athletic Association - NCAA: collaborator

Study Sites (1)

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Athletic Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nicholas A Giordano, PhD, RN

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas A Giordano, PhD, RN

CONTACT

404.727.7980; nicholas.a.giordano@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 13, 2025
• First Posted: October 15, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)