Virtual Reality Mindfulness Meditation for ACL Injury

Overseen by Shelby E Baez, Ph.D., ATC

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: CNS medications

Disqualifiers: Male, Neurological conditions, Pregnancy, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests if using virtual reality for mindfulness meditation can help women who had ACL surgery reduce their fear of injury, improve their movements, and enhance brain activity. The study compares this method to another VR experience over a period of time. Virtual Reality (VR) has been increasingly used to enhance mindfulness practices, showing benefits in mental health and engagement.

Will I have to stop taking my current medications?

The trial requires that participants not be on any medication that affects the central nervous system.

What data supports the effectiveness of the treatment Virtual Reality Mindfulness Meditation for ACL Injury?

Research shows that virtual reality can help reduce anxiety and pain in medical settings, such as during orthopedic procedures and preoperative situations. Additionally, using virtual reality for mindfulness training has been effective in reducing negative emotions and anxiety in patients with spinal cord injuries. ^{1 2 3 4 5}

Is Virtual Reality Mindfulness Meditation safe for humans?

Research on Virtual Reality Mindfulness Meditation shows it is generally safe, with mild side effects like VR sickness (feeling dizzy or nauseous) reported in some cases. Studies involving people with PTSD, chronic pain, and psychosis found no major safety concerns, suggesting it is a safe option for various conditions. ^{6 7 8 9 10}

How does Virtual Reality Mindfulness Meditation treatment differ from other treatments for ACL injury?

Virtual Reality Mindfulness Meditation is unique because it uses immersive technology to deliver mindfulness practices, which can improve mood and reduce stress, potentially enhancing recovery from ACL injuries. Unlike traditional physical therapies, this approach leverages VR to create an engaging and accessible environment for mindfulness, which may also help manage pain and emotional well-being. ^{2 7 8 11 12}

Research Team

Shelby E Baez, Ph.D., ATC

Principal Investigator

UNC-Chapel Hill

Eligibility Criteria

This trial is for females aged 14-25 who had left-side ACL reconstruction surgery 1 to 5 years ago, are right-hand dominant, and injured their knee in sports. They must have MRI compliance, specific levels of fear related to movement (measured by a special scale), and poor jump-landing patterns. Excluded are males, those with recent concussions or CNS medications, claustrophobia, metal implants that can't be removed, under drug influence or pregnant.

Inclusion Criteria

Injured their knee playing or training for sports (recreational or organized)

I have had ACL reconstruction surgery on my left knee.

Have self-reported levels of fear on the Tampa Scale of Kinesiophobia-11

Exclusion Criteria

Presence of metal fragments, pins, plates, or clips, shrapnel, permanent makeup, body piercings that cannot be removed, surgical implants, or orthodontics that cannot be removed

I have a neurological condition like epilepsy.

Pregnancy or suspicion of pregnancy

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 weeks of virtual reality mindfulness meditation or sham intervention along with an advanced neuromuscular training program

8 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in injury-related fear, jump-landing movement patterns, and brain activity

4 weeks

Treatment Details

Interventions

• Virtual Reality Mindfulness Meditation (Behavioural Intervention)
• Virtual Reality Sham (Behavioural Intervention)

Trial Overview The study tests if virtual reality mindfulness meditation helps reduce injury-related fear, improves jump-landing movements and brain activity after ACL surgery compared to a sham VR experience. Participants will be divided into two groups: one experiencing the meditation VR and the other a fake version.

Participant Groups

Group I: VR Mindfulness Meditation Group Experimental Treatment 1 Intervention

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.

Group II: VR Sham Group Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Dr. Lindsey A. Criswell

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Director since 2021

MD, MPH, DSc

Dr. Robert Colbert

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Clinical Director since 2014

MD

Findings from Research

A systematic review of 11 randomized controlled trials involving 892 adult patients found that virtual reality (VR) interventions significantly reduce preoperative anxiety, with VR exposure being particularly effective.

In addition to lowering anxiety, VR interventions also effectively reduced heart rate and blood pressure compared to traditional methods, although they did not significantly impact respiration rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. Gao, Y., Wang, N., Liu, N.[2023]

In a pilot study with 47 healthy participants, both immersive virtual reality (VR) mindfulness and computer-based mindfulness meditation effectively reduced negative emotions, but there were no significant differences in mood improvement between the two methods.

The study found that using VR did not cause simulator sickness, indicating that it is a safe and viable method for delivering mindfulness interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive virtual reality or computerised mindfulness meditation for improving mood? Preliminary efficacy from a pilot randomised trial. Poetar, CR., Bradley, N., Voinescu, A.[2023]

A study involving 77 healthy volunteers demonstrated that a High-Tech VR helmet significantly reduced procedural pain more effectively than a Low-Tech VR helmet, with participants reporting up to 34% less worst pain and 46% less pain unpleasantness.

The High-Tech VR helmet also led to a higher percentage of participants experiencing clinically significant pain reduction (65% vs. 29% in the Low-Tech group), emphasizing the importance of VR technology quality in pain management during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. Hoffman, HG., Seibel, EJ., Richards, TL., et al.[2022]

A study involving 20 patients with spinal cord injury showed that combining virtual reality (VR) training with conventional rehabilitation significantly improved upper limb function compared to conventional therapy alone.

Participants in the VR group experienced notable enhancements in grip strength and overall upper extremity motor scores, indicating that VR can be a safe and effective addition to rehabilitation programs for improving upper limb function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Fully Immersive Virtual Reality Method for Upper Limb Rehabilitation in Spinal Cord Injury. Lim, DY., Hwang, DM., Cho, KH., et al.[2020]

Virtual reality (VR) mindfulness applications show potential benefits for managing chronic pain, including improvements in both physical and mental health, based on a review of seven studies.

However, the effectiveness of these applications is limited by weak study designs and small sample sizes, indicating a need for more rigorous research to validate their impact on health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality-Based Mindfulness for Chronic Pain Management: A Scoping Review. O'Connor, S., Mayne, A., Hood, B.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality to Facilitate Mindfulness Skills Training in Dialectical Behavioral Therapy for Spinal Cord Injury: A Case Study. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Preoperative Virtual Reality Magnetic Resonance Imaging on Preoperative Anxiety in Patients Undergoing Arthroscopic Knee Surgery: A Randomized Controlled Study. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Virtual Reality Analgesia in an Opioid Sparing Orthopedic Outpatient Clinic Setting: A Case Study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Meditating in virtual reality: Proof-of-concept intervention for posttraumatic stress. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The feasibility and effectiveness of virtual reality meditation on reducing chronic pain for older adults with knee osteoarthritis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Immersive virtual reality or computerised mindfulness meditation for improving mood? Preliminary efficacy from a pilot randomised trial. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Effects and safety of virtual reality-based mindfulness in patients with psychosis: a randomized controlled pilot study. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. [2022]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

A Fully Immersive Virtual Reality Method for Upper Limb Rehabilitation in Spinal Cord Injury. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality-Based Mindfulness for Chronic Pain Management: A Scoping Review. [2022]