Virtual Reality Biofeedback for Postoperative Pain

No longer recruiting at 1 trial location

Overseen By Julie Rice-Weimer, RN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Vanessa Olbrecht

Must not be taking: Opioids, Benzodiazepines

Disqualifiers: Developmental delay, Epilepsy, Chronic pain, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests virtual reality biofeedback as a new method to manage pain after surgery in children and teens. Researchers are evaluating two technology-based treatments to determine their effectiveness for postoperative care. The trial seeks English-speaking children and teens aged 12-18 who are scheduled for surgery likely to cause moderate to severe pain and require at least a two-day hospital stay. Participants must also have access to a mobile device or computer for the study. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques and contribute to advancements in postoperative care for young patients.

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

The trial does not specify if you need to stop taking your current medications. However, if you are chronically using opioids or benzodiazepines for pain management, you may not be eligible to participate.

What prior data suggests that this technology-based treatment protocol is safe for children and adolescents undergoing surgery?

Research has shown that using virtual reality (VR) to manage pain after surgery is generally safe. Many studies have found that VR is easy to use and effective for people of all ages, including children and teens. While these studies often focus on VR's ability to reduce pain, they report very few safety issues.

The FDA, a government agency that ensures the safety of medical devices, classifies the VR technology used in these treatments as a "relaxation device." This classification indicates it is very low risk and unlikely to cause harm. Using VR to distract patients has been shown to lower pain and anxiety without causing negative side effects.

Although different VR systems might function slightly differently, studies consistently show they are safe to use. Therefore, those considering joining a clinical trial using VR for pain relief can feel reassured about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality biofeedback for postoperative pain because it offers a non-drug approach to managing pain, which could reduce reliance on opioids and other medications. Unlike traditional pain management methods that often involve pharmaceuticals, this approach uses immersive technology to help patients gain better control over their pain response. Additionally, the biofeedback component allows patients to see real-time data about their physiological responses, potentially leading to faster recovery and improved outcomes. By providing an engaging, interactive experience, this method might not only ease pain but also enhance patients' overall recovery experience.

What evidence suggests that this trial's technology-based interventions could be effective for postoperative pain?

Research has shown that virtual reality (VR) biofeedback can help reduce pain after surgery in children and teens. Studies have found that interactive VR can significantly lower pain levels. Recent findings in young patients suggest VR effectively decreases pain intensity. In this trial, participants will join different technology-based intervention groups to evaluate VR biofeedback's effectiveness. When combined with biofeedback, a method to help control body functions, VR has produced promising results in easing pain when used regularly after surgery. Using VR three times a day post-surgery might enhance its pain-relief benefits. These studies suggest VR biofeedback is a promising tool for managing pain in young patients after surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Vanessa Olbrecht, MD

Principal Investigator

Nemours Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 12-18 who are about to have surgery that will likely cause moderate to severe pain and require a hospital stay of at least two days. Participants must speak English, be managed by the Acute Pain Service, and have access to a mobile device or computer. It's not for those with developmental delays, uncontrolled psychiatric conditions, chronic pain, vertigo, seizures, severe motion sickness or those using opioids/benzodiazepines regularly.

Inclusion Criteria

Possession of a mobile device/computer available for study participation

I am scheduled for surgery expected to cause significant pain and a hospital stay of 2 or more days.

I am under the care of the Acute Pain Service for my pain management.

Exclusion Criteria

I have a long-term history of pain.

I have had surgery or have abnormalities in my head or neck area.

I have no history of severe developmental delays, uncontrolled psychiatric conditions with hallucinations or delusions, or major neurological issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Training

Participants undergo preoperative training using the technology-based intervention

Up to 2 weeks

Postoperative Intervention

Participants receive the technology-based intervention to manage postoperative pain

2-7 days

Follow-up

Participants are monitored for satisfaction, anxiety, and pain management effectiveness

Up to 2 weeks post intervention

What Are the Treatments Tested in This Trial?

Interventions

• Technology Based Intervention Group 1
• Technology Based Intervention Group 2

Trial Overview

The study is testing a new technology-based treatment protocol involving virtual reality as preoperative education/training and postoperative care for young patients undergoing surgery. The goal is to see if this approach can help manage their post-surgery pain better than current methods.

How Is the Trial Designed?

Group I: Technology Based Intervention 2 (Phase 2) Experimental Treatment 1 Intervention

Group II: Technology Based Intervention 1 (Phase 2) Experimental Treatment 1 Intervention

Group III: Technology Based Intervention 1 (Phase 1) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vanessa Olbrecht

Lead Sponsor

Trials

2

Recruited

220+

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

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]

Virtual reality (VR) biofeedback (BF) therapy has been shown to effectively reduce anxiety, stress, and pain, with outcomes comparable to traditional biofeedback methods, based on a review of 18 studies involving mostly healthy adult participants.

Participants in VR-BF interventions reported higher motivation and better user experiences, suggesting that while VR may not yet be proven more effective than traditional BF, it offers advantages in engagement and attentional focus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Biofeedback in Health: A Scoping Review. Lüddecke, R., Felnhofer, A.[2022]

This study is testing the feasibility of using biofeedback-based virtual reality (VR-BF) for pain management in children and adolescents undergoing surgery, with 70 participants aged 12-18 years involved in a randomized controlled trial.

The primary goal is to evaluate how well VR-BF can be integrated into perioperative care, while secondary aims include assessing its acceptability and initial effectiveness in reducing pain, anxiety, and opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of perioperative application of biofeedback-based virtual reality versus active control for pain and anxiety in children and adolescents undergoing surgery: protocol for a pilot randomised controlled trial. Orgil, Z., Johnson, L., Karthic, A., et al.[2023]

A systematic review and meta-analysis of 30 studies involving 1,293 burn patients found that virtual reality (VR) significantly reduces pain severity during wound care procedures, with a strong effect size (SMD: -0.70).

Immersive VR interventions were particularly effective in decreasing pain intensity compared to control groups, while non-immersive VR did not show significant benefits, suggesting that immersive VR should be prioritized in burn care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality-Based Interventions on Pain During Wound Care in Burn Patients; a Systematic Review and Meta-Analysis. Norouzkhani, N., Chaghian Arani, R., Mehrabi, H., et al.[2022]

Self-administered Virtual Reality (VR) has been found to effectively aid in managing postsurgical pain, with patients reporting benefits and no serious drawbacks during its use.

Patients preferred intuitive, immersive 3D VR experiences and recommended using VR 2-3 times a day for 10-15 minutes, highlighting the importance of tailoring VR interventions to individual needs for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Administered Virtual Reality for Postsurgical Pain Management: A Qualitative Study of Hospital Patients' Reported Experiences. Lier, EJ., Smits, MLM., de Vries, M., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12185076/

Immersive Virtual Reality for Postoperative Pain Among ...

Our review presents varied results. First, studies using more interactive IVR environments tended to show significant decreases in pain scores.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/12331363

Virtual Reality for Pediatric Postoperative Pain Management

Recent studies involving various pediatric surgical populations have demonstrated VR's potential to reduce postoperative pain intensity, pain ...

3.

periop.jmir.org

periop.jmir.org/2024/1/e48959

Use of Biofeedback-Based Virtual Reality in Pediatric ...

... VR-BF effective for pain reduction, with daily once postoperative use. It is possible that “dosing” VR-BF 3 times daily after surgery could ...

4.

bmjopen.bmj.com

bmjopen.bmj.com/content/bmjopen/13/1/e071274.full.pdf

based virtual reality versus active control for pain

The primary outcome is feasibility of VR- BF use in adolescents undergoing surgery as assessed through recruitment, enrolment, retention and ...

5.

acrjournals.onlinelibrary.wiley.com

acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr2.70048

Efficacy of Immersive Virtual Reality Combined With ...

The primary outcome was reduction in visual analog scale (VAS) pain scores in the TR group, after five IVR-BF sessions, compared to the WL group ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04943874

Biofeedback Based Virtual Reality Intervention to Manage ...

This is not an FDA-regulated drug or device trial as the technology used in this study is categorized as a relaxation device by the FDA and considered "minimal ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8056576/

A virtual reality-based intervention for surgical patients

As far as we know, to date, there are no studies estimating the effectiveness of VR for postoperative pain following surgery under general anesthesia in a ...

8.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08975-8

Effectiveness and safety of adjuvant software based on virtual ...

The primary outcome measure will be the effectiveness of the VR-based adjuvant analgesic software, as assessed by the reduction in NRS scores ...

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S003960602400391X

Virtual reality for postsurgical pain management

VR is safe and suitable for a wide target audience, and feasibility differed between interventions. Personalizing and improving VR technology may enhance its ...

10.

jmir.org

jmir.org/2025/1/e68348

Virtual Reality for Pediatric Postoperative Pain Management

Several VR modalities have shown potential for reducing pain and anxiety in pediatric populations, including virtual reality–distraction therapy ...