NCT04251988

VR to Reduce Pain and Anxiety During GU Scans

The Effectiveness of Virtual Reality (VR) to Reduce Pain and Anxiety During Genitourinary (GU) Scans

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 5 Years – 21 Years
• Healthy volunteers: Accepted

Summary

This study aims to test the effectiveness of virtual reality (VR) in reducing pain and anxiety in children undergoing voiding cystourethrograms (VCUG) at Children's Hospital Los Angeles (CHLA). A voiding cystourethrogram is a genitourinary diagnostic scan that provides important urological information, specifically the filling and releasing of the bladder. This information can help diagnose urological issues in children. However, this procedure requires catheterization, which is understood to be a painful and anxiety-provoking procedure. This study will test the effectiveness of VR as a non-pharmaceutical intervention to relieve pain and anxiety in pediatric patients undergoing VCUGs.

Detailed description

Background: VCUGs are genitourinary diagnostic scans that provide valuable medical information for pediatric patients with urological issues. However, these scans require catheterization, which can be anxiety-provoking, painful, and in some cases traumatic. Previous studies have assessed the use of pharmacological agents to address pain and anxiety during these procedures, but few studies exist examining non-pharmacological interventions in a methodologically rigorous way. As pharmacological interventions are associated with numerous side effects, and may not be appropriate for all pediatric patients, effective non-pharmacological interventions are needed for patients undergoing VCUGs. Aims: This study aims to determine the effectiveness of virtual reality (VR) in reducing pain and anxiety among children undergoing VCUGs at CHLA. This study will also assess patient, parent, and provider satisfaction with VR, and ease of completing VCUGs using VR vs. the standard of care. Study Population: CHLA patients aged 5-21 years receiving VCUGs at CHLA. Methods: A stratified randomization scheme will be used to assign patients aged 5-21 undergoing VCUG scans to receive the standard of care (i.e. caregiver presence in the room and Child Life Specialists in the room if desired), or the standard of care plus VR. Individuals assigned to the VR arm will be fitted with a Samsung head-tracking system, and will play an AppliedVR game prior to and during catheterization. Standardized questionnaires will be administered to patients and caregivers before and after the procedure to measure pain and anxiety. Satisfaction questionnaires will be administered post-procedure. Significance: VR is a non-invasive intervention that, if effective, could become part of a standard protocol to reduce pain and anxiety among children undergoing VCUGs. As there is a dearth of knowledge regarding non-pharmacologic interventions for children receiving VCUGs, this study will provide a foundation to inform future research on VR use among pediatric urology patients. See 'References' for Brief Summary References

Conditions

• Urologic Diseases
• Urogenital Disease
• Vesico-Ureteral Reflux

Interventions

Type	Name	Description
DEVICE	Oculus Go VR	virtual reality headset

Timeline

• Start date: 2020-02-15
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-02-05
• Last updated: 2023-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study