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?

This trial aims to determine if virtual reality (VR) can reduce symptoms in individuals with non-cardiac chest pain (NCCP), meaning chest pain unrelated to heart issues. Participants will use VR therapy, a form of immersive therapy, to potentially alleviate discomfort. Suitable participants should have ongoing chest pain not linked to heart problems and previous tests confirming no severe esophagus issues. As an unphased trial, this study provides a unique opportunity to explore innovative therapy options for symptom relief.

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.

What prior data suggests that virtual reality therapy is safe for non-cardiac chest pain?

Research shows that virtual reality (VR) therapy is generally safe for managing pain and anxiety. Studies have found that VR effectively reduces anxiety in patients undergoing heart procedures and helps control pain during various medical treatments.

Another study examined VR for long-term pain management in rehabilitation settings and found it safe and effective. This indicates that VR does not cause significant side effects or harm.

Overall, based on these studies, VR therapy appears to be a promising tool for relieving pain and anxiety without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for treating chest pain because it offers a unique, non-invasive approach that differs from traditional options like medications and physical therapy. Unlike standard treatments that primarily focus on addressing the physical aspects of pain, VR therapy engages patients' senses and cognitive processes, which may help distract them from pain and reduce anxiety. This innovative method can potentially provide quick relief without the side effects often associated with pain medications, offering a promising alternative for those seeking a holistic and integrative approach to pain management.

What evidence suggests that virtual reality is effective for non-cardiac chest pain?

Research has shown that virtual reality (VR) therapy can help reduce pain. A study from Cedars-Sinai found that patients in the hospital experienced less pain when using VR therapy. VR distracts patients, which can lessen their perception of pain. Other studies also indicate that VR can help manage pain during medical procedures. Although specific data on non-cardiac chest pain (NCCP) is lacking, these findings suggest VR might help by using similar pain relief methods. In this trial, all participants will receive virtual reality therapy to evaluate its effectiveness for chest pain. ^{1 3 6 7 8}

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

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]

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]

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]

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 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]

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]

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 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]

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]

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]

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]

Citations

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Early health economic analysis of virtual reality therapy for ... Virtual reality (VR) therapy is increasingly used to mitigate pain and anxiety in inpatient settings, with varying effectiveness in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10865524/

Efficacy of virtual reality for pain relief in medical procedures Immersive VR technology offers effective pain control across various medical procedures, albeit statistical heterogeneity.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1098301521015400

Using Virtual Reality Exposure Therapy in Pain ... This study aimed to assess the effectiveness of virtual reality (VR) in managing different types of pain in different age groups.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04601545

The Virtual Reality Therapy as a Pulmonary Rehabilitation ... In this study the investigators want to assess the effectiveness of the virtual reality (VR) therapy compared to standard psychological support (Schultz ...

5. cedars-sinai.org cedars-sinai.org/newsroom/cedars-sinai-study-finds-virtual-reality-therapy-helps-decrease-pain-in-hospitalized-patients/

Cedars-Sinai Study Finds Virtual Reality Therapy Helps ... Virtual reality therapy is effective in significantly reducing pain for hospitalized patients, according to a new Cedars-Sinai study.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0146280624001713

Effectiveness of virtual reality on pain and anxiety in ... Virtual reality, compared to standard care, significantly reduced anxiety levels in patients undergoing cardiac procedures.

7. games.jmir.org games.jmir.org/2024/1/e54389/

Pulmonary and Physical Virtual Reality Exercises for Patients ... In this study, the primary aim was to assess the effectivity of breathing and physical exercises using VR on the pulmonary recovery of patients ...

8. scientificarchives.com scientificarchives.com/article/virtual-reality-in-chronic-pain-rehabilitation-a-systematic-review

Virtual Reality in Chronic Pain Rehabilitation: A Systematic ... VR interventions are safe and effective for chronic pain management in rehabilitation settings. Immersive and non-immersive techniques are used in VR ...