Virtual Reality for Chest Pain

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Proton pump inhibitors

Disqualifiers: Major illness, Drug/alcohol use, Vertigo, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot start a proton pump inhibitor (a type of medication for stomach acid) within 8 weeks before joining.

Is virtual reality therapy safe for use in humans?

Virtual reality therapy has been used safely in various settings, including for pain management in burn injuries and chronic pain, with most patients experiencing mild or no side effects like nausea. It is considered a low-risk, non-drug treatment option that can improve mood and reduce pain without significant adverse effects. ^{1 2 3 4 5}

How does virtual reality treatment for chest pain differ from other treatments?

Virtual reality treatment for chest pain is unique because it uses immersive technology to potentially reduce anxiety and pain through distraction and enhanced procedural understanding, unlike traditional methods that may rely on medication or physical interventions. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Virtual Reality Therapy for chest pain?

Research shows that virtual reality (VR) can help reduce pain by immersing people in a computer-simulated environment, which has been effective in managing pain from burns and other conditions. This suggests that VR might also help with chest pain by providing a distraction and reducing the perception of pain. ^{2 5 8 10 11}

Who Is on the Research Team?

Andree Koop, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people with non-cardiac chest pain who've had tests to rule out severe esophagus issues and heart problems. They shouldn't have started new acid reflux medication recently, have major illnesses, substance abuse issues, or vertigo that would make using VR hard.

Inclusion Criteria

Negative prior cardiac evaluation (including electrocardiogram)

I experience chest pain that is not related to heart issues.

I've had tests to check for severe throat or swallowing problems.

Exclusion Criteria

Major concomitant illness

Current drug or alcohol use that would interfere with adherence to study requirements

I started taking a proton pump inhibitor less than 8 weeks ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive virtual reality therapy to assess its feasibility and effectiveness in treating non-cardiac chest pain

2 weeks

1 visit (in-person), multiple virtual sessions

Follow-up

Participants are monitored for changes in symptoms, anxiety, and quality of life after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview The study is testing if virtual reality can help ease chest pain that's not related to the heart. Participants will use a VR headset as part of the treatment to see if it improves their symptoms.

How Is the Trial Designed?

Group I: VR Arm Experimental Treatment 1 Intervention

Viritual Reality therapy arm. All patients will receive virtual reality therapy.

Virtual Reality is already approved in United States for the following indications:

Approved in United States as Virtual Reality Therapy for:

• Functional Dyspepsia
• Irritable Bowel Syndrome (IBS)
• Gastroparesis

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The study found that a virtual reality (VR) program, when added to conventional cardiac rehabilitation for patients with ischemic heart disease, led to significant improvements in various fitness and health measures, including exercise capacity and quality of life, despite no significant differences between the VR and control groups overall.

Patients using the VR program reported high levels of satisfaction and adherence, indicating that this innovative approach could enhance the rehabilitation experience for individuals recovering from heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Virtual Reality on Cardiac Rehabilitation Programs for Ischemic Heart Disease: A Randomized Pilot Clinical Trial. García-Bravo, S., Cano-de-la-Cuerda, R., Domínguez-Paniagua, J., et al.[2021]

A systematic review of 122 randomized controlled trials involving 9,138 patients found that virtual reality (VR) significantly reduces pain, with a standardized mean difference of -0.65, indicating a strong effect across various types of pain, including acute, chronic, and procedural.

The effectiveness of VR in pain management was particularly notable in younger patients and those experiencing moderate to severe pain, suggesting that VR could be a valuable tool for these groups, although the studies showed considerable variability and moderate to high risk of bias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect modifiers of virtual reality in pain management: a systematic review and meta-regression analysis. Lier, EJ., de Vries, M., Steggink, EM., et al.[2023]

A review of 11 controlled studies indicates that virtual reality (VR) distraction is effective in reducing both experimental pain and discomfort during burn injury care.

More advanced VR technology that fully immerses users in a virtual environment tends to provide greater pain relief, suggesting that VR could be a valuable tool for clinicians managing various pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality distraction for pain reduction: a systematic review. Malloy, KM., Milling, LS.[2022]

In a study of 39 adults with burn injuries, immersive virtual reality (VR) significantly reduced pain scores during physical therapy sessions, with reductions of 27% in worst pain, 37% in time spent thinking about pain, and 31% in pain unpleasantness compared to standard therapy without VR.

The use of VR did not negatively impact the range of motion (ROM) during therapy, and 97% of patients reported only zero to mild nausea, indicating that VR is a safe and effective nonpharmacologic option for pain management in postburn rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of virtual reality on pain and range of motion in adults with burn injuries. Carrougher, GJ., Hoffman, HG., Nakamura, D., et al.[2021]

In a case series involving 10 chronic pain patients, 5 reported reduced pain during virtual reality (VR) therapy sessions, suggesting potential short-term benefits of VR for pain management.

While VR therapy did not show significant overall changes in pain scores after treatment, it was safe with no serious adverse events, although 60% of participants experienced some cybersickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. Garrett, B., Taverner, T., McDade, P.[2020]

This study demonstrates that immersive virtual reality (VR) can significantly increase heat-pain tolerance limits in healthy participants, suggesting its potential as a nonpharmacological intervention for pain management.

VR not only enhances pain tolerance but also improves mood and reduces situational anxiety when the experience is enjoyable, although these mood changes do not directly affect pain tolerance levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality: physiological and behavioral mechanisms to increase individual pain tolerance limits. Colloca, L., Raghuraman, N., Wang, Y., et al.[2022]

A systematic review of nine studies on the use of immersive virtual reality (VR) for pain and anxiety management in cancer patients showed a trend towards improvement, but only two studies demonstrated statistically significant results.

The current evidence is inconclusive due to methodological limitations and small sample sizes, highlighting the need for further research to better understand the effectiveness of VR in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. Chow, H., Hon, J., Chua, W., et al.[2021]

In a study involving 22 older adults with chronic back pain, the immersive Virtual Reality (VR) therapy group showed a significant improvement in functional capacity after four weeks, increasing from 73.11% to 81.82%.

While the VR therapy did not significantly reduce pain intensity compared to conventional therapy, both groups experienced a reduction in pain, indicating that VR can still be a beneficial tool for managing chronic pain in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exergame for supplementing multimodal pain therapy in older adults with chronic back pain: a randomized controlled pilot study. Stamm, O., Dahms, R., Reithinger, N., et al.[2022]

This systematic review and meta-analysis aims to evaluate the effectiveness of virtual reality (VR) technology in reducing anxiety and pain during cardiac procedures, comparing it to standard care, based on randomized controlled trials (RCTs).

Previous studies suggest that VR can enhance patient experiences by improving understanding of procedures and potentially leading to better outcomes, making it a promising tool for managing anxiety and pain in cardiac settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality on anxiety and pain management in patients undergoing cardiac procedures: a protocol for systematic review and meta-analysis. Bashir, Z., Misquith, C., Has, P., et al.[2023]

In a study involving 34 patients with coronary artery disease, VR therapy significantly reduced symptoms of anxiety and depression, as shown by a decrease in Hospital Anxiety and Depression Scale (HADS) scores after 4 weeks of treatment.

Unlike the control group, which received standard autogenic training, the VR therapy group experienced a notable reduction in stress levels, indicating that immersive VR can effectively enhance cardiac rehabilitation for patients with mental health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality Therapy as a Support for Cardiac Rehabilitation: A Pilot Randomized-Controlled Trial. Szczepańska-Gieracha, J., Jóźwik, S., Cieślik, B., et al.[2021]

Virtual reality (VR) has shown promise in pain management by utilizing distraction techniques, as evidenced by a review of six studies that included both adults and children with various pain conditions.

In addition to distraction, VR may induce neurophysiologic changes that could lead to new treatment options for chronic pain, potentially reducing reliance on opioids, though further large-scale studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It? Gupta, A., Scott, K., Dukewich, M.[2022]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Virtual Reality on Cardiac Rehabilitation Programs for Ischemic Heart Disease: A Randomized Pilot Clinical Trial. [2021]

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

Effect modifiers of virtual reality in pain management: a systematic review and meta-regression analysis. [2023]

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

The effectiveness of virtual reality distraction for pain reduction: a systematic review. [2022]

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

The effect of virtual reality on pain and range of motion in adults with burn injuries. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. [2020]

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

Virtual reality: physiological and behavioral mechanisms to increase individual pain tolerance limits. [2022]

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

Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Virtual reality exergame for supplementing multimodal pain therapy in older adults with chronic back pain: a randomized controlled pilot study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality on anxiety and pain management in patients undergoing cardiac procedures: a protocol for systematic review and meta-analysis. [2023]

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

Immersive Virtual Reality Therapy as a Support for Cardiac Rehabilitation: A Pilot Randomized-Controlled Trial. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It? [2022]