Virtual Reality Mindfulness Meditation for Patients After Anterior Cruciate Ligament Reconstruction: Protocol for the Development of a National Institutes of Health Stage 1 Behavioral Intervention.

Background: About 1 in 3 individuals will sustain a secondary anterior cruciate ligament (ACL) injury within 24 months of returning to sport after ACL reconstruction (ACLR). While aberrant biomechanics and poor quadriceps strength have been associated with secondary ACL injury risk, unresolved injury-related fear has also been identified as a potential risk factor for additional ACL injuries in previously high-functioning, physically active populations. Virtual reality mindfulness meditation (VRMM) is a psychological intervention that may reduce injury-related fear and improve an individual's ability to stay in the present moment during stressful situations such as sport. There is a critical need to identify whether VRMM is a feasible intervention that could be implemented to address injury-related fear and reduce secondary ACL injury risk. Objective: This study aims to determine the feasibility, acceptability, and preliminary efficacy of a VRMM intervention with neuromuscular training rehabilitation (NTR) to reduce injury-related fear and improve jump-landing biomechanics in females with a history of ACLR, when compared to a sham virtual reality (VR) intervention+NTR. Methods: A double-blinded, 2-arm feasibility trial of 48 participants (24 per group) comparing VRMM+NTR and VR sham+NTR will be conducted. Recruitment, retention, adherence, and acceptability outcomes will be collected throughout the trial. Injury-related fear will be measured using the 11-Item Tampa Scale of Kinesiophobia. Jump-landing biomechanics will be assessed via peak knee abduction moment and peak knee flexion excursion. The change in outcomes will be compared between groups using 2×2 repeated measures ANOVA and partial η2 effect sizes. Significance will be set at P<.05. Results: The study was funded in May 2021. The trial started in September 2023 and is anticipated to be completed in May 2027, with the first results expected to be submitted for publication in winter 2027. We expect to observe acceptable rates of retention, adherence, and acceptability to the VRMM intervention and more favorable outcomes in the VRMM+NTR group compared to the VR sham+NTR group. As of now, 55 participants have been screened for eligibility, of which 33 were ineligible. Twelve participants have been randomized, and 10 have completed the trial. Two participants withdrew from the trial before the completion of the full intervention protocol due to the study time commitment. Conclusions: The results of this trial will improve our understanding of the feasibility of VRMM and inform the next steps in behavioral intervention development to test the efficacy of VRMM in reducing injury-related fear in females after ACLR.