Virtual Reality for Preoperative Anxiety in Pediatric Cancer Patients

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Neethu Chandran

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial uses a VR device to help reduce anxiety in children aged 5-12 undergoing cancer treatment procedures. The VR goggles show interactive videos to distract the children, making them less anxious. The study aims to see if this method can lower anxiety levels by at least five percent.

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.

What data supports the idea that Virtual Reality for Preoperative Anxiety in Pediatric Cancer Patients is an effective treatment?

The available research shows that virtual reality (VR) can be effective in reducing anxiety and pain in pediatric cancer patients. One study found that VR had a medium and significant effect on reducing anxiety and pain compared to standard care. Another study reported that children experienced lower distress levels during medical procedures when using VR, although it didn't significantly change anxiety levels. Additionally, both patients and their families reported high satisfaction with VR, and healthcare professionals found it easy to use and beneficial. These findings suggest that VR is a promising tool for managing anxiety and improving the overall experience for young cancer patients. ^{1 2 3 4 5}

What safety data exists for using virtual reality to reduce anxiety in pediatric cancer patients?

The available studies indicate that virtual reality (VR) is a safe intervention for reducing anxiety in pediatric cancer patients. A prospective randomized clinical trial found no adverse events related to VR use in children undergoing elective surgery. Additionally, systematic reviews and meta-analyses suggest VR is effective in managing anxiety and pain in pediatric oncology without reporting safety concerns. However, further studies with larger sample sizes are recommended to strengthen the evidence base. ^{1 5 6 7 8}

Is virtual reality a promising treatment for reducing preoperative anxiety in children with cancer?

Yes, virtual reality is a promising treatment for reducing preoperative anxiety in children with cancer. It offers a unique way to gradually expose children to medical environments, which can help lower anxiety. VR is also highly accepted by children and their families, and it may reduce distress during painful procedures. ^{1 2 7 9 10}

Research Team

Sarah Rebstock, MD

Principal Investigator

UT Southwestern

Neethu Chandran

Principal Investigator

UT Southwestern

Eligibility Criteria

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.

Treatment Details

Interventions

• Virtual Reality (Behavioural Intervention)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Kiley Poppino Dallas, TX

UT Southwestern Dallas, TX

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1102

Patients Recruited

1,077,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Virtual reality for pain and anxiety of pediatric oncology patients: A systematic review and meta-analysis. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a VR Intervention to Decrease Anxiety in Children with Tumors Undergoing CVC Dressing. [2023]

3. United States 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. [2021]

4. Scotland 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. [2022]

5. United States 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. [2023]

6. United States 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. [2022]

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

Effects of immersive virtual reality exposure in preparing pediatric oncology patients for radiation therapy. [2023]

8. Switzerland 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. [2023]

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

Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. [2020]

10. Canada 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. [2020]