Mindfulness intervention for patients undergoing ACL surgery
The Influence of Mindfulness on Patient-Reported Outcomes, Return to Sport and Re-Injury Following Anterior Cruciate Ligament (ACL) Reconstruction Surgery
This study is testing whether an 8-week mindfulness program delivered through an app can help people recovering from ACL surgery feel better, manage pain and anxiety, and get back to sports safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 16 Years to 40 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05542563 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of an 8-week mindfulness intervention delivered remotely via the Healthy Minds Program App for patients undergoing anterior cruciate ligament (ACL) reconstruction surgery. It aims to assess improvements in patient-reported outcomes such as pain, quality of life, anxiety, and the likelihood of returning to sports. The study employs a single-blind, randomized controlled trial design to determine the impact of mindfulness training on both psychological and physical recovery following surgery. Additionally, it seeks to explore the potential reduction in re-injury risk among participants who return to sports after the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16-40 who are scheduled for ACL surgery and have access to a compatible mobile device.
Not a fit: Patients with serious mental illnesses or significant prior experience with mindfulness practices may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve recovery outcomes and quality of life for ACL surgery patients.
How similar studies have performed: Other studies have shown promising results with mindfulness interventions in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 16-40 years old at the time of the pre-operative visit * Regular access to a mobile device compatible with the Healthy Minds Program (HMP) App (Android or iOS) * Undergoing ACL surgery Exclusion Criteria: * Prior diagnosis of serious mental illness (schizophrenia, bipolar disorder, schizoaffective disorder, etc). * Significant prior experience with meditation or mindfulness, defined as greater than 30 minutes in a month during the past year * Knee injury requiring multi-ligament reconstruction * Prior ipsilateral knee surgery * Prior contralateral ACL reconstruction
Where this trial is running
Madison, Wisconsin
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Watson, MD, MS — University of Wisconsin, Madison
- Study coordinator: Kristin Haraldsdottir
- Email: ACLMindfulnessResearch@ortho.wisc
- Phone: 608-263-6647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.