Virtual Reality for Procedure-Related Pain

Overseen By Amaad Sulahria, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Pregnancy, Prisoners, Motion sickness, 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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness of virtual reality (VR) distraction in patients undergoing interventional pain procedures in the prone position. VR has been shown to improve patient experience during interventional pain procedures, however, many of these procedures are done in the prone position making VR a challenge. This study will evaluate the effect of a VR headset and support in patients undergoing prone interventional pain procedures compared to control.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Virtual Reality Headset for procedure-related pain?

Research shows that using virtual reality (VR) as a distraction can effectively reduce pain during medical procedures. Studies found that VR can decrease pain intensity and fear, especially when the technology is advanced enough to fully immerse users in a virtual environment. ^{1 2 3 4 5}

Is virtual reality safe for reducing procedure-related pain?

Research shows that using virtual reality (VR) for pain distraction is generally safe for healthy volunteers and patients undergoing medical procedures. Studies have not reported significant safety concerns, and VR is considered a non-drug method to help manage pain. ^{2 4 6 7 8}

How does virtual reality treatment differ from other treatments for procedure-related pain?

Virtual reality (VR) treatment is unique because it uses immersive, three-dimensional environments to distract patients from pain, unlike traditional methods that often rely on medications. This non-drug approach can reduce pain by enhancing the illusion of being in a virtual world, which has been shown to be more effective with advanced VR technology. ^{1 2 4 6 7}

Research Team

Michael Jung, MD MBA

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for adults over 18 who need a pain procedure at the University of California Davis Pain Medicine Clinic, can speak English, and understand instructions. It's not for pregnant women, prisoners, or those with motion sickness risks, seizures, or hearing/vision problems.

Inclusion Criteria

I can speak and understand English instructions.

I am 18 or older and need a pain procedure at UC Davis Pain Clinic.

Exclusion Criteria

I am at high risk for motion sickness, seizures, or have trouble seeing/hearing.

Prisoners

Pregnant women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo prone pain procedures with or without virtual reality distraction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for patient experience satisfaction, sedation requirements, anxiety, and pain scores

Immediately after procedure

Treatment Details

Interventions

• Virtual Reality Headset

Trial Overview The study tests if using a VR headset helps reduce anxiety and pain in patients lying face down during pain procedures compared to those without VR. The effectiveness of this distraction method is being evaluated.

Participant Groups

Group I: Virtual Reality Experimental Treatment 1 Intervention

Patients undergo prone pain procedure with virtual reality distraction

Group II: Control Active Control 1 Intervention

Patients undergo prone pain procedure without virtual reality distraction

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Findings from Research

A study involving 100 hospitalized patients showed that a one-time 3D virtual reality (VR) intervention significantly reduced pain more than a 2D distraction video, with an average pain reduction of -1.3 points compared to -0.6 points for the control group.

The VR intervention was not only effective, with 65% of patients experiencing a meaningful pain response, but it was also safe, as no adverse events were reported during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. Tashjian, VC., Mosadeghi, S., Howard, AR., et al.[2020]

In a study involving healthy volunteers aged 18-20, participants using High Tech virtual reality (VR) reported a stronger sense of immersion and significantly greater pain reduction compared to those using Low Tech VR, with reductions of 3.1 vs. 0.7 in worst pain ratings.

The effectiveness of VR in reducing pain was positively correlated with the level of immersion experienced, suggesting that enhancing the illusion of being in a virtual world can improve pain distraction during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manipulating presence influences the magnitude of virtual reality analgesia. Hoffman, HG., Sharar, SR., Coda, B., et al.[2008]

In a study involving 59 children aged 8-17, virtual reality (VR) was found to significantly reduce fear of pain during medical procedures compared to traditional Child Life interventions and watching television.

While VR did not show a significant difference in pain intensity compared to the other methods, children reported higher satisfaction with the VR experience, suggesting it is an effective and engaging distraction tool in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial on the Use of Virtual Reality for Needle-Related Procedures in Children and Adolescents in the Emergency Department. Dumoulin, S., Bouchard, S., Ellis, J., et al.[2020]

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]

A systematic review of 17 randomized controlled trials involving 1008 children found low-certainty evidence that virtual reality (VR) distraction may reduce acute pain intensity during and after medical procedures, but results were inconsistent and varied by the type of VR used.

While some studies indicated that immersive VR could be beneficial in reducing pain, many showed no significant effects compared to no distraction or other non-VR methods, highlighting the need for more robust research to clarify the effectiveness and safety of VR interventions for pain management in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality distraction for acute pain in children. Lambert, V., Boylan, P., Boran, L., et al.[2023]

In a study involving 14 patients undergoing total knee arthroplasty, the use of virtual reality (VR) distraction significantly reduced the need for intravenous sedation, with only 1 out of 7 patients in the VR group requiring sedation compared to 6 out of 7 in the usual care group.

Patients using VR distraction experienced lower fentanyl and midazolam dosages, as well as reduced procedure-related pain, indicating that VR can be an effective nonpharmacological method to manage pain during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality distraction decreases routine intravenous sedation and procedure-related pain during preoperative adductor canal catheter insertion: a retrospective study. Pandya, PG., Kim, TE., Howard, SK., et al.[2019]

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]

Biofeedback-based virtual reality (VR-BF) is a promising nonpharmacologic approach to pain management that could help reduce the need for opioids in children and adolescents after surgery, addressing the opioid epidemic's impact on this vulnerable population.

In a study involving 23 surgical patients, VR-BF was evaluated for its feasibility and acceptability, aiming to establish a treatment protocol that includes preoperative education and postoperative application to manage pain effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dataset used to refine a treatment protocol of a biofeedback-based virtual reality intervention for pain and anxiety in children and adolescents undergoing surgery. Orgil, Z., Karthic, A., Bell, N., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. [2020]

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

Manipulating presence influences the magnitude of virtual reality analgesia. [2008]

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

A Randomized Controlled Trial on the Use of Virtual Reality for Needle-Related Procedures in Children and Adolescents in the Emergency Department. [2020]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Virtual reality distraction for acute pain in children. [2023]

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

Virtual reality distraction decreases routine intravenous sedation and procedure-related pain during preoperative adductor canal catheter insertion: a retrospective study. [2019]

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

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Dataset used to refine a treatment protocol of a biofeedback-based virtual reality intervention for pain and anxiety in children and adolescents undergoing surgery. [2023]