Virtual Reality Biofeedback for Postoperative Pain

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

93 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

To develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery.

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.

Is virtual reality biofeedback safe for humans?

Research on virtual reality biofeedback (VR-BF) shows it is generally safe for humans, with studies involving children, adolescents, and adults reporting no significant safety concerns. Participants often experience higher motivation and better user experience compared to traditional biofeedback methods. ^{1 2 3 4 5}

How does the Virtual Reality Biofeedback treatment for postoperative pain differ from other treatments?

Virtual Reality Biofeedback (VR-BF) is unique because it combines virtual reality with biofeedback, a mind-body therapy that helps patients learn to control involuntary processes like heart rate. This approach not only provides pain relief by redirecting attention but also enhances motivation and user experience, making it more engaging than traditional biofeedback or medication-based treatments. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for postoperative pain management?

Virtual reality (VR) has been shown to effectively reduce pain in various conditions, including postoperative pain, by providing immersive experiences that distract patients from pain. Combining VR with biofeedback (a technique that helps people control bodily processes) may enhance these benefits by teaching relaxation techniques and improving heart rate variability, which can help manage pain. ^{2 3 6 7 8}

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

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]

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]

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]

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]

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]

Citations

1. England 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. [2023]

2. 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]

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

Effect of Virtual Reality on Pain Management and Opioid Use Among Hospitalized Patients After Head and Neck Surgery: A Randomized Clinical Trial. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Self-Administered Virtual Reality for Postsurgical Pain Management: A Qualitative Study of Hospital Patients' Reported Experiences. [2023]

5. Iran 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. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Virtual Reality Biofeedback in Health: A Scoping Review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Designing and developing a nature-based virtual reality with heart rate variability biofeedback for surgical anxiety and pain management: evidence from total knee arthroplasty patients. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Virtual Reality Neurofeedback Therapy as a Novel Modality for Sustained Analgesia in Centralized Pain Syndromes. [2021]