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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual reality (VR) can reduce pain during certain medical procedures performed while lying face-down. The goal is to determine if a virtual reality headset (also known as VR Headset or Virtual Reality Distraction Therapy) can make the experience more comfortable compared to not using VR. Patients who need a pain procedure at the UC Davis Pain Medicine Clinic and can understand English might be eligible. However, this trial is not suitable for those prone to motion sickness or with certain health issues, such as seizure disorders. As an unphased trial, this study offers a unique opportunity to explore innovative pain management techniques.

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 prior data suggests that this virtual reality technique is safe for patients undergoing interventional pain procedures?

Research has shown that using virtual reality (VR) headsets is generally safe for easing pain during medical procedures. Studies have found that VR can lower pain and anxiety levels. For example, children who used VR during needle procedures felt less scared and experienced less pain.

No reports of serious side effects have emerged from using a VR headset in these situations. Most people handle VR well, though some might feel slightly dizzy or uncomfortable if they wear the headset for too long. Overall, VR is considered a safe way to help people feel more at ease during medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for managing procedure-related pain because it offers a unique, non-drug approach to pain relief. Unlike traditional pain treatments that often rely on medications, VR uses immersive distraction to engage the brain and reduce the perception of pain. This method can minimize the need for painkillers, potentially reducing the side effects and risks associated with medication use. Plus, VR can be customized for different patients and settings, making it a versatile tool for pain management.

What evidence suggests that virtual reality is effective for procedure-related pain?

Research has shown that virtual reality (VR) can help reduce pain during medical procedures. People using VR often report feeling less pain and stress. For instance, VR has been found to lower pain by a full point on a pain scale and reduce anxiety. One study found that children using VR during procedures felt much less pain and anxiety compared to those who did not use it. In this trial, participants will undergo a prone pain procedure either with VR distraction or without it. Overall, VR is becoming a promising tool for managing pain during various medical procedures. ^{3 4 6 7 8}

Who Is on the Research Team?

Michael Jung, MD MBA

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3138477/

Virtual reality and pain management: current trends and future ...

In clinical settings and experimental studies, participants immersed in VR experience reduced levels of pain, general distress/unpleasantness and report a ...

2.

bmcmedicine.biomedcentral.com

bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03266-6

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/S0882596325000697

Virtual reality for distraction during painful procedures in ...

The study shows how VR affects the pain and anxiety of pediatric surgery patients. Children in the experimental group reported less pain and anxiety.

4.

researchprotocols.org

researchprotocols.org/2024/1/e52649

Effectiveness of Virtual Reality in Reducing Perceived Pain ...

Results: The study is already underway, and results support a decrease in perceived pain by 1.00 and a decrease in perceived anxiety by 0.3 ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03680625?tab=table

Virtual Reality vs Passive Distraction for Pain Management

A recent randomized-controlled trial comparing VR and standard distraction in children undergoing blood drawn procedures, demonstrated a significant positive ...

6.

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.

7.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT05157893?lupd_s=12%2F02%2F2021&lupd_d=14

Effects of Virtual Reality (VR) Based Distraction and ...

This study is a pilot study to explore the use of VR based distraction and relaxation therapy as an adjunctive analgesic method for Chinese patients with ...

8.

psychiatry-psychopharmacology.com

psychiatry-psychopharmacology.com/Content/files/sayilar/1/PCP_20251216_nlm_new_indd.pdf

Virtual Reality Headset Use During Venipuncture in Children

In this study, children who used a virtual reality (VR) headset during venipuncture experienced significantly less fear and pain.