Virtual Reality for Preoperative Anxiety in Pediatric Cancer Patients

No longer recruiting at 1 trial location

Overseen By Sarah E Rebstock

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Age, PICU recovery, Developmental delays, 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: 4

Duration: 1 session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) can reduce anxiety in children with cancer who need port access for treatment. The goal is to determine if VR as a distraction lowers anxiety levels compared to not using VR. Children aged 5-12 who require port access at least twice in six months may be suitable for this study. The trial will compare children playing a VR game before their procedure with those who do not use VR to assess which method more effectively calms nerves. As an unphased study, this trial provides a unique opportunity to explore innovative ways to ease anxiety during medical procedures.

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

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications, as the study focuses on using virtual reality to reduce anxiety and does not mention medication changes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using virtual reality to reduce anxiety, so it's unlikely that your medications would be affected.

What prior data suggests that this virtual reality device is safe for pediatric cancer patients?

Research has shown that virtual reality (VR) is safe and effective for reducing anxiety in children with cancer. Studies have found that VR helps children better understand medical procedures and reduces anxiety for both them and their parents. The VR device is non-invasive, meaning it doesn't go inside the body. By distracting the child, it helps reduce anxiety. The device resembles goggles and poses minimal risk, with measures in place to prevent discomfort or infection. Overall, VR appears well-tolerated and safe for children undergoing medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for reducing preoperative anxiety in pediatric cancer patients because it offers a non-invasive and engaging way to help kids relax before procedures. Unlike traditional methods like medication or psychological interventions, VR immerses patients in a different environment, distracting them and potentially lowering anxiety levels without side effects. This approach could make hospital experiences less stressful for young patients, improving their overall well-being and cooperation during medical procedures.

What evidence suggests that virtual reality is effective for reducing preoperative anxiety in pediatric cancer patients?

Research shows that virtual reality (VR) can help reduce anxiety in children with cancer. In this trial, some participants will use VR therapy, which studies have found lowers anxiety before medical procedures for both kids and their parents. Reviews of multiple studies show that VR effectively manages anxiety and pain in children with cancer and is safe to use. Additionally, VR therapy has proven effective in helping patients with anxiety disorders feel less anxious. These findings suggest that VR could be a useful tool to help children feel less anxious during medical procedures. ^{2 3 5 6 7}

Who Is on the Research Team?

Neethu Chandran

Principal Investigator

UT Southwestern

Sarah Rebstock, MD

Principal Investigator

UT Southwestern

Are You a Good Fit for This Trial?

This trial is for kids aged 5-12 with cancer, treated at the CCBD clinic, who need a port (a long-term IV) accessed multiple times over six months. They must understand and agree to participate. It's not suitable for those outside this group.

Inclusion Criteria

Patients who receive care at Children's Medical Center CCBD cannot participate in the study.

Being able to understand and agreeing to sign a written agreement.

I use a port for chemotherapy and blood tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Anxiety Assessment

Participants undergo preoperative anxiety assessment using the modified Yale Preoperative Anxiety Scale (mYPAS) with or without VR distraction

15 minutes

1 visit (in-person)

Treatment

Participants are randomized to receive either VR or non-VR distraction methods prior to port access

1 session

1 visit (in-person)

Follow-up

Participants are monitored for anxiety levels and any adverse effects post-procedure

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview The study tests if Virtual Reality (VR) can lower anxiety in kids before they get medical procedures like port access. Kids will be randomly chosen to use VR or standard distraction methods first, and their anxiety levels will be compared using a special scale.

How Is the Trial Designed?

Group I: VR (Virtual Reality) Experimental Treatment 1 Intervention

The patient is assigned to play the VR game for 15 minutes prior to actual port access procedure start. mYPAS scoring while playing VR device for Port access

Group II: Non-VR (Virtual reality) Active Control 1 Intervention

The patient is not assigned to play the VR game. mYPAS scoring for port access is done.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

In a study involving 22 children with tumors, a virtual reality (VR) intervention significantly reduced distress levels during painful medical procedures compared to no VR, with median distress scores of 2 versus 4.

While the VR intervention did not show a measurable impact on anxiety levels, it was highly accepted by children and their families, suggesting potential for routine clinical use, though further research with larger samples is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a VR Intervention to Decrease Anxiety in Children with Tumors Undergoing CVC Dressing. Russo, L., Tozzi, AE., Mastronuzzi, A., et al.[2023]

A study involving 30 children aged 6-18 years undergoing radiation therapy showed that an immersive Virtual Reality (VR) intervention significantly reduced anxiety levels in both children and their parents, enhancing their understanding of the procedures.

The VR intervention was highly accepted by participants, with only one child (3.33%) requiring general anesthesia after the intervention, suggesting that VR could improve compliance and reduce the need for more invasive sedation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of immersive virtual reality exposure in preparing pediatric oncology patients for radiation therapy. Tennant, M., Anderson, N., Youssef, GJ., et al.[2023]

A systematic review of six randomized controlled trials involving 379 pediatric cancer patients found that virtual reality (VR) significantly reduces pain, anxiety, and fear symptoms, indicating its efficacy as a supportive treatment.

The results showed a notable decrease in pain (mean difference of -4.82), anxiety (standardized mean difference of -1.47), and fear (mean difference of -1.25) when using VR, suggesting it can be a valuable tool in managing the psychological and physical discomfort of young cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for pain and anxiety of pediatric oncology patients: A systematic review and meta-analysis. Cheng, Z., Yu, S., Zhang, W., et al.[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]

The study aims to evaluate a virtual reality exposure (VRE) tool designed to prepare children aged 4 to 12 for surgery, with a focus on reducing preoperative anxiety and improving overall surgical experience, in a randomized controlled trial involving 200 participants.

The VRE intervention is expected to significantly reduce preoperative anxiety, postoperative pain, and the need for analgesics, potentially leading to a less stressful experience for both children and their parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial. Eijlers, R., Legerstee, JS., Dierckx, B., et al.[2020]

Virtual reality interventions significantly reduce pain and anxiety in children and adolescents undergoing cancer treatment, with medium effect sizes of 0.60 for anxiety and -0.667 for pain based on a meta-analysis of seven randomized controlled trials.

Age was identified as an important factor influencing the effectiveness of virtual reality for pain management, highlighting the need for further large-scale randomized controlled trials to strengthen the evidence for its use in pediatric oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality in Anxiety and Pain Management in Children and Adolescents Receiving Cancer Treatment: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Ozturk, CS., Toruner, EK.[2023]

A study involving 90 pediatric oncology patients and their caregivers found that an Immersive VR therapeutic intervention was highly acceptable and satisfactory, with minimal adverse effects reported by patients.

Healthcare professionals expressed favorable perceptions of the VR technology, indicating it was easy to use and useful, suggesting strong potential for future implementation in pediatric oncology settings to improve patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Clinical Implementation of an Immersive Virtual Reality Intervention to Address Psychological Well-Being in Children and Adolescents With Cancer. Tennant, M., McGillivray, J., Youssef, GJ., et al.[2021]

The study involving 19 pediatric cancer patients showed that immersive virtual reality significantly reduced anxiety and acute nausea during their first chemotherapy sessions, indicating its potential effectiveness as a supportive intervention.

The high consent and low withdrawal rates suggest that immersive virtual reality is not only feasible but also well-accepted by patients, parents, and healthcare providers in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of immersive virtual reality for managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: An exploratory randomised controlled trial. Lee Wong, C., Li, CK., Choi, KC., et al.[2022]

In a study of 40 children aged 12 to 17 undergoing elective surgery, preoperative virtual reality (VR) significantly reduced heart rates and anxiety levels compared to a control group, indicating its efficacy in managing preoperative anxiety.

The VR group reported a much more positive experience in the operating room, with higher relaxation scores and no adverse events related to the VR intervention, suggesting it is a safe and effective tool for anxiety relief in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Virtual Reality Program in Pediatric Surgery to Reduce Anxiety and Distress Symptoms in the Preoperative Phase: A Prospective Randomized Clinical Trial. Esposito, C., Autorino, G., Iervolino, A., et al.[2022]

A systematic review of 13 studies involving children and adolescents with cancer found that virtual reality (VR) can effectively reduce pain during invasive procedures, particularly during painful vascular access.

There is limited evidence on the effectiveness of VR for reducing anxiety in pediatric cancer patients, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive and Non-Immersive Virtual Reality for Pain and Anxiety Management in Pediatric Patients with Hematological or Solid Cancer: A Systematic Review. Comparcini, D., Simonetti, V., Galli, F., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9640949/

Virtual reality for pain and anxiety of pediatric oncology ... The aim of this paper is to systematically evaluate the effects of virtual reality (VR) on pain, anxiety, and fear symptoms of pediatric patients with cancer.

2. sciencedirect.com sciencedirect.com/science/article/pii/S240563242100024X

Effects of immersive virtual reality exposure in preparing ... The VR intervention was found to improve children's understanding of the RT procedures (health literacy) and lower pre-procedural child and parental anxiety.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11904249/

Effectiveness of virtual reality therapy in the treatment ... The current findings suggest that VR therapy interventions have a positive effect on improving the anxiety state of patients with anxiety disorders.

4. withpower.com withpower.com/trial/phase-anxiety-disorders-2021-33edc

Virtual Reality for Preoperative Anxiety in Pediatric Cancer ... Additionally, systematic reviews and meta-analyses suggest VR is effective in managing anxiety and pain in pediatric oncology without reporting safety concerns.

5. jmir.org jmir.org/2025/1/e55291

Effects of Virtual Reality–Based Interventions on ... Compared with usual care, VR-based interventions showed substantial benefits in decreasing preoperative anxiety in patients undergoing elective ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11951881/

Virtual reality on perioperative anxiety in pediatric patients Virtual reality is a nonpharmacological intervention that alleviates pain and preoperative anxiety through cognitive distraction, redirecting patients' focus ...

7. researchprotocols.org researchprotocols.org/2024/1/e55692

An Immersive Virtual Reality Intervention for Preoperative ... This study seeks to develop and investigate a targeted PSA intervention in patients undergoing oncological surgery using a single preoperative VR exposure.