NCT04479735

Virtual Reality Goggle Utilization for Venipuncture Distraction

Optimizing the Patient Experience: Virtual Reality Goggle Utilization for Venipuncture Distraction - Can we Decrease Anxiety and Pain During This Common Procedure?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 5 Years – 21 Years
• Healthy volunteers: Accepted

Summary

This is a randomized non-blinded trial evaluating the effect of virtual reality goggles on perceived pain and anxiety scores during venipuncture on hospitalized children ages 5-21. We will randomized patients to either standard of care (including Lidocaine 2.5%/Prilocaine 2.5% cream as a topical anesthetic 60-240 minutes prior to venipuncture) or standard of care plus virtual reality goggles.

Detailed description

Study personnel will identify patients on CHAM 6 and CHAM 8 scheduled for lab draw prior to child life rounds and subsequently ask the health care providers if there are any patients that are not developmentally or physically appropriate to use the VR equipment. They will then screen and consent the patients approximately 1 hour prior to the Child Life rounds (see appendix A \& B). Patients aged 12-17 years old who are able to read the form will be asked to fill out an assent form (see appendix C) and patients aged 5-12 years old and those unable to read the form will be read the assent form to ensure verbal assent. Those patients who consent to the study will be randomized to a VR arm and non VR arm using computer generated randomization. Lidocaine 2.5%/Prilocaine 2.5% cream will be placed on all patients that have consented to the study by the patient's nurse if they don't already have it applied. After consent and assurance of topical anesthetic application, a brief demographic questionnaire (see appendix D) will also be completed. For efficiency and feasibility, two study personnel will screen and consent families, assist with VR set up and removal, and conduct post procedure assessment.

Conditions

• Pain, Procedural

Interventions

Type	Name	Description
DEVICE	Virtual Reality Goggles	Virtual reality goggles will placed at least 2 min prior to venipuncture to deteremine if it mitigates perceived anxiety or perceived pain scores.

Timeline

• Start date: 2021-07-16
• Primary completion: 2025-10-20
• Completion: 2025-10-20
• First posted: 2020-07-21
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States