Recruiting

Mindfulness Training

Sponsor:

Emory University

Code:

NCT07217275

Conditions

Athletic Injuries

Sport Injuries

Eligibility Criteria

Sex: All

Age: 18 - 26

Healthy Volunteers: Accepted

Interventions

Community Resiliency Model (CRM)

Control

Study Details

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

Study ID

NCT07217275

Start date

Nov 1, 2025

Status verified date

Dec, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 26

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.)

Exclusion Criteria:

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Community Resiliency Model (CRM)

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®.

active comparator: Standard of Care (SOC)

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

Interventions

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®. 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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nicholas A Giordano, PhD, RN

404.727.7980nicholas.a.giordano@emory.edu

Locations

Emory Orthopaedics and Spine Center

Recruiting

Atlanta, Georgia, United States, 30329

More Information

Sponsor

Emory University

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • Orthopedic surgery
  • Student Athletes
  • Mindfulness skills

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-12-16.