Therapeutic VR for Pain and Anxiety

Overseen By Man Yee Suen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Severe cognitive impairment, Seizures, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of hospitalization

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using virtual reality for pain and anxiety, so it's best to ask the trial coordinators for more details.

What data supports the effectiveness of the treatment Therapeutic VR for Pain and Anxiety?

Research shows that virtual reality (VR) can effectively reduce pain and anxiety in various settings, such as during medical procedures and surgeries. Studies have found that VR helps distract patients from pain and can also provide relaxation, making it a promising tool for managing both acute and chronic pain. ^{1 2 3 4 5}

Is therapeutic VR safe for humans?

Research on virtual reality (VR) for pain management suggests it is generally safe, with few studies reporting adverse events (unwanted side effects). VR is considered a low-risk, non-drug treatment that can help with pain and anxiety. ^{1 2 6 7 8}

How does Therapeutic VR for Pain and Anxiety differ from other treatments?

Therapeutic VR for Pain and Anxiety is unique because it uses immersive virtual reality to manage pain and anxiety without medication, potentially altering brain networks associated with pain. This treatment can be administered with or without a trained facilitator, offering flexibility and a novel approach compared to traditional pain management methods. ^{1 2 6 7 9}

What is the purpose of this trial?

The study aims to investigate therapeutic virtual reality (VR) facilitation with adult inpatients using VR as an analgesic and anxiolytic during their hospitalization. Specifically, this study will evaluate the outcomes of patients who experience therapeutic VR with and without a trained facilitator as a form of escapism.

Eligibility Criteria

This trial is for adults over 18 who can consent, follow instructions, and use VR equipment with their hands. They must be stable in the hospital, speak English, willing to try therapeutic VR, and have anxiety from their medical condition (VAS-A score >4). It's not for those with aggression issues, seizure history, severe motion sickness or nausea, visual or cognitive impairments that prevent using a VR headset.

Inclusion Criteria

Experiencing anxiety related to their medical condition as evidenced by a VAS-A score >4 at time of enrollment

English speaking

Able to provide informed consent

Exclusion Criteria

Isolation room

Facial trauma prohibiting headset use

Physical limitations in facial, neck, upper extremities that hinder use of VR equipment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants experience therapeutic virtual reality with or without a trained facilitator during their hospitalization

Duration of hospitalization

Daily sessions during hospital stay

Follow-up

Participants are monitored for changes in anxiety, pain, stress, and loneliness immediately after the intervention

Immediately after intervention

Treatment Details

Interventions

• Therapeutic VR with a trained facilitator
• Therapeutic VR without a trained facilitator

Trial Overview The study tests if therapeutic virtual reality (VR) helps hospitalized patients feel less pain and anxiety. One group uses VR with a trained facilitator guiding them; another tries it without help. The goal is to see if having someone assist makes the experience more effective as an escape from discomfort.

Participant Groups

Group I: Therapeutic VR a trained facilitator. Experimental Treatment 1 Intervention

Group II: Therapeutic VR without a trained facilitator. Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Virtual reality (VR) has been found to be an effective method for reducing both acute and chronic pain, with significant improvements in pain intensity (72.1%) and quality (75.0%) observed across 70 studies involving 4105 participants.

The primary mechanism of pain relief through VR is distraction, especially for acute pain, while embodiment is more commonly associated with chronic pain, indicating that different types of pain may benefit from tailored VR approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The State of Science in the Use of Virtual Reality in the Treatment of Acute and Chronic Pain: A Systematic Scoping Review. Baker, NA., Polhemus, AH., Haan Ospina, E., et al.[2023]

Virtual reality (VR) therapies have shown promise in effectively distracting patients from both acute and chronic pain, suggesting a new approach to pain management beyond traditional methods like opioids and physical therapy.

Clinical studies indicate that VR can be beneficial for various pain conditions, including fibromyalgia and phantom limb pain, by immersing patients in interactive environments that reduce their perception of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. Pourmand, A., Davis, S., Marchak, A., et al.[2018]

A study involving 32 patients undergoing head and neck surgery found that different virtual reality (VR) experiences did not significantly differ in their effectiveness for reducing perioperative anxiety and pain, suggesting that both preoperative gaming and postoperative mindfulness VR can be equally beneficial.

Patients reported high satisfaction with both VR interventions, and there were no adverse events, indicating that VR is a safe and effective tool for managing anxiety and pain in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Perioperative Virtual Reality Experiences on Anxiety and Pain: A Randomized Comparative Trial. Pandrangi, VC., Low, G., Slijepcevic, A., et al.[2023]

The Relaxation-VR application is an effective tool for managing pain and anxiety in pediatric patients aged 4-16 years during medical procedures, showing significant reductions in anxiety, pain, and stress while increasing happiness.

Both pediatric patients and clinicians found the use of VR to be acceptable, feasible, and tolerable, highlighting its potential for broader adoption in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for Distraction and Relaxation in a Pediatric Hospital Setting: An Interventional Study With a Mixed-Methods Design. Bernaerts, S., Bonroy, B., Daems, J., et al.[2022]

This study is evaluating the effectiveness of guided relaxation-based virtual reality (VR-GR) compared to distraction-based VR (VR-D) and a passive control (360 video) in managing pain for 90 children and adolescents undergoing surgery, with a focus on pain intensity and related psychological factors.

The trial aims to determine if VR-GR can provide more lasting pain relief than traditional distraction methods, potentially reducing the need for opioid and benzodiazepine medications post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). Olbrecht, VA., Williams, SE., O'Conor, KT., et al.[2021]

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 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 novel virtual reality neuroscience-based therapy (VRNT) significantly reduced pain intensity and interference in 31 participants with chronic back pain compared to usual care, with effects lasting for at least two weeks after treatment.

VRNT not only improved pain-related outcomes but also enhanced overall functioning by potentially altering brain networks associated with pain, as indicated by MRI findings showing changes in connectivity and white matter integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Virtual Reality Neuroscience-based Therapy on Clinical and Neuroimaging Outcomes in Patients with Chronic Back Pain: A Randomized Clinical Trial. Čeko, M., Baeuerle, T., Webster, L., et al.[2023]

References

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

The State of Science in the Use of Virtual Reality in the Treatment of Acute and Chronic Pain: A Systematic Scoping Review. [2023]

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

Virtual Reality as a Clinical Tool for Pain Management. [2018]

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

Use of Perioperative Virtual Reality Experiences on Anxiety and Pain: A Randomized Comparative Trial. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality for Distraction and Relaxation in a Pediatric Hospital Setting: An Interventional Study With a Mixed-Methods Design. [2022]

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

Use of Virtual Reality to Distract From Pain and Anxiety. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). [2021]

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

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

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

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

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

The Effects of Virtual Reality Neuroscience-based Therapy on Clinical and Neuroimaging Outcomes in Patients with Chronic Back Pain: A Randomized Clinical Trial. [2023]