Virtual Reality Biofeedback for Postoperative Pain
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Training
Participants undergo preoperative training using the technology-based intervention
Postoperative Intervention
Participants receive the technology-based intervention to manage postoperative pain
Follow-up
Participants are monitored for satisfaction, anxiety, and pain management effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- Technology Based Intervention Group 1
- Technology Based Intervention Group 2
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanessa Olbrecht
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator