Virtual Reality Mindfulness Meditation After ACL Reconstruction
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- University of North Carolina, Chapel Hill
- Study ID
- NCT05527171
- Status
- Recruiting
Conditions
- Anterior Cruciate Ligament Injury
Eligibility Criteria
- Sex
- FEMALE
- Age
- 14 Years - 25 Years
- Healthy Volunteers
- Not accepted
Interventions
- Virtual Reality Mindfulness Meditation — BEHAVIORALParticipants will be immersed in a virtual environment of their choosing. While in the virtual environment, participants will follow a guided mindfulness meditation script. Participants will complete the intervention 3 times a week over the course of 8-weeks.
- Virtual Reality Sham — BEHAVIORALParticipants will be immersed in a virtual environment of their choosing, such as at a beach, forest, or lake.
Study Details
To evaluate the effect of virtual reality mindfulness meditation on patients after ACLR, the investigators will determine the effect of virtual reality mindfulness meditation to 1) decrease self-reported injury-related fear, 2) improve poor jump-landing movement patterns, and 3) improve brain activity in women 1 to 5 years post-ACLR when compared to a virtual reality sham group.
Key Dates
- Start date
- Sep 5, 2023
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 48 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: VR Mindfulness Meditation GroupParticipants will complete 8-weeks of virtual reality mindfulness meditation and an advanced neuromuscular training program. Mindfulness meditation is the practice of sustaining attention on the body, breath, or sensations in any given moment and allows for the self-regulation of attention by decreasing rumination about past or future events. During the practice of mindfulness meditation, the individual is aware of all incoming thoughts and feelings, but rather than reacting to them, the individual accepts them. Virtual reality mindfulness meditation has been demonstrated to be superior in inducing mindfulness states when compared to traditional mindfulness meditation. Use of a virtual reality system to implement mindfulness meditation not only decreases the barrier of time to implement psychological interventions, but also improves the clinician's confidence in implementing the intervention as the virtual reality system guides the patient through the mindfulness meditation process.
- Sham Comparator: VR Sham GroupParticipants will complete 8-weeks of virtual reality sham and an advanced neuromuscular training program. Participants will be immersed in a virtual environment but will not receive the mindfulness meditation.
Primary Outcome Measure
Percentage of participants who were eligible and enrolled in the study [ Time Frame: Through study completion, a total of approximately 3 years. ]
Central Contacts
- Shelby E Baez, Ph.D., ATC910-273-1821
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fetzer Hall, 210 South Road | Chapel Hill | North Carolina | 27514 | Shelby E Baez, PhD |
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