VR Therapy for Pain and Anxiety During Medical Procedures

Overseen By Nhat Ngo, BS, BA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Must not be taking: Pain medications, Anxiolytics

Disqualifiers: Psychiatric disorder, Cognitive disorders, Seizure, others

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

Compensation: Varies

Number of Visits: 1

Duration: Single session

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality (VR) might reduce pain and anxiety in children during medical procedures, such as receiving an IV or having a cast removed. Researchers compare the standard care at Children's Hospital Los Angeles with an added VR experience using devices like Merge VR and Oculus Go. Children aged 7 to 21, who speak English and undergo a painful procedure, may qualify if they are not currently on pain or anxiety medication and do not have certain medical conditions. The goal is to determine if VR can make these experiences less stressful and painful for children. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could transform pediatric care.

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

Yes, if you are currently taking pain or anxiety medications, you cannot participate in this trial.

What prior data suggests that virtual reality is safe for reducing pain and anxiety in children during medical procedures?

Research has shown that virtual reality (VR) is generally safe and effective for managing pain during medical procedures. Studies have found that VR can help control pain in various situations, such as surgeries and long-term pain conditions.

Most people tolerate VR therapy well. However, if discomfort occurs, it is important to stop using it. Some individuals might experience dizziness or headaches, so taking breaks is advisable if needed.

Overall, VR is considered a safe method to reduce pain and anxiety, especially for children undergoing medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VR therapy for managing pain and anxiety during medical procedures because it offers a totally different approach compared to traditional methods like medication or sedation. Unlike these standard treatments, VR therapy uses immersive virtual environments to distract and engage patients, which can reduce the perception of pain and anxiety without the side effects associated with drugs. This cutting-edge technique not only provides a novel delivery method through head-mounted displays but also has the potential to enhance the overall patient experience, making medical procedures less daunting for children.

What evidence suggests that VR is effective for reducing pain and anxiety in children during medical procedures?

Research has shown that virtual reality (VR) therapy can help reduce pain and anxiety during medical procedures. In this trial, some participants will receive VR therapy, engaging with virtual worlds to distract them during their procedures. Studies have found that VR technology effectively controls pain through such distractions. For children undergoing painful procedures, VR can significantly lower pain and anxiety. Reviews highlight VR's success in managing sudden pain, making it a promising tool for pain relief without medication. Using VR in medical settings offers a fun and engaging way to ease discomfort during difficult procedures. ^{1 3 6 7 8}

Who Is on the Research Team?

Jeffrey I Gold, PhD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for children aged 7-21 who speak English, undergoing painful medical procedures like IV placements or cast removals. They must be developing normally as reported by parents and not taking pain or anxiety medication, have no seizure history, flu-like symptoms, cognitive disorders, sensory deficits, or motion sickness.

Inclusion Criteria

Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.

This criterion does not provide specific information.

Inclusion criteria for healthcare providers:

Exclusion Criteria

My child has a history of seizures.

My child gets motion sickness.

My child is currently experiencing flu-like symptoms, a headache, or an earache.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo painful medical procedures with or without VR distraction

Single session

1 visit (in-person)

Follow-up

Participants are monitored for pain and anxiety levels post-procedure

Approximately 5-15 minutes after procedure

Data Analysis

Data collected from surveys and scales are analyzed to assess the effectiveness of VR

What Are the Treatments Tested in This Trial?

Interventions

• Merge VR
• Oculus Go
• Samsung Gear VR

Trial Overview The study tests if VR headsets (Samsung Gear VR, Merge VR, Oculus Go) can reduce pain and anxiety in kids during medical procedures at CHLA. It measures their comfort levels through what they and their caregivers say.

How Is the Trial Designed?

Group I: VR Randomization Experimental Treatment 3 Interventions

Children in the VR condition will undergo the invasive procedure while distracted by interaction with an immersive virtual environment (VE) presented via a head mounted display (HMD). The intervention group will receive standard CHLA treatment with VR distraction.

Group II: Standard of Care (No VR) Randomization Active Control 1 Intervention

In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for the medical procedure.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

AppliedVR Inc.

Industry Sponsor

Trials

11

Recruited

3,100+

Published Research Related to This Trial

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]

Virtual reality (VR) has been shown to effectively reduce pain and anxiety in patients undergoing dental treatments, particularly in children, with a significant effect size of -0.82 for pain reduction based on a meta-analysis of 10 studies.

Despite its effectiveness in pediatric patients, there is a need for more research on the use of VR for adults and its potential as a preparatory tool for dental treatments, as current studies are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality for the Management of Anxiety and Pain in Dental Treatments: Systematic Review and Meta-Analysis. López-Valverde, N., Muriel Fernández, J., López-Valverde, A., et al.[2020]

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]

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]

Virtual reality (VR) therapy has shown potential to improve clinical outcomes, such as reduced pain and anxiety, in adult patients undergoing surgical procedures, based on a review of 18 studies.

Factors like patient comfort and healthcare worker concerns about cost-effectiveness and infection control influence the acceptability and feasibility of VR therapy in acute care settings, indicating a need for further research to solidify its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions and the outcome measures of adult patients in acute care settings undergoing surgical procedures: An integrative review. Wang, S., Lim, SH., Aloweni, FBAB.[2022]

A meta-analysis of 17 studies involving pediatric patients showed that virtual reality (VR) significantly reduces pain (SMD = 1.30) and anxiety (SMD = 1.32) during medical procedures, indicating its effectiveness as a distraction tool.

The research primarily focused on VR as a distraction during procedures like burn care, but more studies are needed to explore its potential as a preparatory tool for medical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Eijlers, R., Utens, EMWJ., Staals, LM., et al.[2020]

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 clinical trial involving 107 young patients (ages 10-21) undergoing peripheral intravenous catheter placement, those who used a virtual reality (VR) intervention reported significantly lower levels of pain and anxiety compared to those receiving standard care.

The VR group showed a reduction in anxiety scores by 1.85 points and pain scores by 1.34 points, indicating that VR can be an effective tool for improving the experience of painful medical procedures in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an Immersive Virtual Reality Intervention on Pain and Anxiety Associated With Peripheral Intravenous Catheter Placement in the Pediatric Setting: A Randomized Clinical Trial. Gold, JI., SooHoo, M., Laikin, AM., et al.[2022]

A case study demonstrated that immersive virtual reality (VR) significantly reduced pain intensity by 43% and anxiety by 43% during the removal of external fixator pins in a conscious patient, compared to standard care without VR.

Using VR as a non-pharmacologic analgesic not only improved patient satisfaction with pain management but also has the potential to lower opioid use and associated risks during outpatient orthopedic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Virtual Reality Analgesia in an Opioid Sparing Orthopedic Outpatient Clinic Setting: A Case Study. Firoozabadi, R., Elhaddad, M., Drever, S., et al.[2021]

An 11-year-old burn patient experienced significant pain reduction during therapy when using inexpensive Oculus Rift Virtual Reality (VR) goggles, with pain intensity ratings dropping from severely painful to moderately painful.

This study suggests that immersive VR environments can be an effective and cost-efficient method for managing acute procedural pain in burn patients, warranting further research into its broader applications in pain control and therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of articulated arm mounted Oculus Rift Virtual Reality goggles for adjunctive pain control during occupational therapy in pediatric burn patients. Hoffman, HG., Meyer, WJ., Ramirez, M., et al.[2022]

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]

In a feasibility study involving 14 veterans, a virtual reality (VR) treatment modeled after mirror therapy significantly reduced phantom limb pain (PLP) intensity, with only 28.6% of participants reporting PLP after treatment compared to 57.1% before.

Participants rated the VR treatment highly in terms of helpfulness, realism, and satisfaction, with no adverse experiences reported, indicating that VR could be a safe and effective option for managing PLP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virtual Reality Intervention for the Treatment of Phantom Limb Pain: Development and Feasibility Results. Rutledge, T., Velez, D., Depp, C., et al.[2020]

Citations

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10382225/

Virtual reality for pain management: an umbrella review This umbrella review demonstrates successful application of virtual reality in pain control, including perioperative, periprocedural, and chronic pain settings.

3. withpower.com withpower.com/trial/phase-anxiety-disorders-1-2016-1480b

VR Therapy for Pain and Anxiety During Medical Procedures This trial tests if VR can reduce pain and anxiety in children aged 7-21 during medical procedures by distracting them with a virtual world.

4. researchgate.net researchgate.net/publication/378210965_Efficacy_of_virtual_reality_for_pain_relief_in_medical_procedures_a_systematic_review_and_meta-analysis

(PDF) Efficacy of virtual reality for pain relief in medical ... We aimed to evaluate the efficacy of Immersive virtual reality (VR) technology in reducing patient's pain perception during various medical ...

5. valueinhealthjournal.com valueinhealthjournal.com/article/S1098-3015(21)01540-0/fulltext

Using Virtual Reality Exposure Therapy in Pain Management VR can effectively alleviate acute pain. In terms of chronic low back pain and cancer-related pain, there was no statistical difference between ...

6. mergeedu.com mergeedu.com/health-safety

Health & Safety Information | AR/VR Learning & Creation NEVER continue to use the Merge Headset if you are experiencing any discomfort. WARNING-IN THE EVENT YOU EXPERIENCE DISCOMFORT. IMMEDIATELY DISCONTINUE USE ...

7. 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 ...

8. jamda.com jamda.com/article/S1525-8610(23)00036-1/fulltext

Fully Immersive Virtual Reality Using 360° Videos to ... The aim of this scoping review is to assess the effectiveness of 360° interventions on well-being in older adults with or without cognitive impairment.