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 — BEHAVIORAL
    Participants 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 — BEHAVIORAL
    Participants 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 Group
    Participants 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 Group
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Fetzer Hall, 210 South RoadChapel HillNorth Carolina27514
Shelby E Baez, PhD

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