Active — Not RecruitingNot Applicable

Mindfulness and ACL Surgery

United States47 participantsStarted 2022-07-01

Plain-language summary

Anterior cruciate ligament (ACL) surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential long-lasting adverse effects such as muscle weakness, diminished joint function, hip pain, and fear. Many of these patients report more significant anxiety and depression following surgery, which can further compound these patients' adverse outcomes. This study is a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes (PROs) following ACL reconstruction surgery.

Who can participate

Age range16 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in PROMIS Global Health Questionnaire (GHQ) Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Change in PROMIS Anxiety Questionnaire Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Change in PROMIS Depression Questionnaire Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Change in Single Assessment Numeric Evaluation (SANE) Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Change in Horowitz Impact of Events Scale Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Change in Tampa Scale of Kinesiophobia 11 (TSK-11) Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Change in Pain Catastrophizing Scale (PCS) Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Trial details

NCT IDNCT05542563

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

View on ClinicalTrials.gov More ACL trials

Plain-language summary

Who can participate

Age range16 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in PROMIS Global Health Questionnaire (GHQ) Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Change in PROMIS Anxiety Questionnaire Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Change in PROMIS Depression Questionnaire Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Change in Single Assessment Numeric Evaluation (SANE) Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Change in Horowitz Impact of Events Scale Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Change in Tampa Scale of Kinesiophobia 11 (TSK-11) Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery

Change in Pain Catastrophizing Scale (PCS) Score

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery