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?

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Procedural
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Courtney A McNamara, MD; Phone Number: 540 514 4389; Email: comcnama@montefiore.org
• Study Contact Backup: Name: Katherine O'Connor, MD; Phone Number: (917) 776-0512; Email: koconnor@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

patients aged 5-21 years old admitted to the 6th floor of the inpatient unit who are scheduled for a venipuncture during morning phlebotomy rounds

Exclusion Criteria:

Patients developmentally or physically not appropriate to use the VR equipment as determined by their parent, guardian or healthcare provider, if there is discomfort related to wearing the goggles (for example: recent neurosurgery, migraines, hardware on head), patient have photosensitive seizures or infectious concern such as scabies, lice, COVID-19 that can't reliably be disinfected.

Patient (>18) or Parent or guardian (for patient < 18) that does not speak English, Spanish or Arabic will be excluded.

If patient refuses Lidocaine 2.5%/Prilocaine 2.5% cream use they will also be excluded from the study.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR goggle with venipuncture; Virtual reality goggles SamsungGearVR supplied by KindVR will be placed on patients at least 2 min prior to venipuncture. All patients will also receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture.	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.
No Intervention: no VR goggle with venipuncture; Patients will receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture but NO virtual reality goggles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perceived Pain: scale	change in the perceived pain using Wong-Baker FACES scale pre/post venipuncture. Faces scale converts 6 faces to numbers (0, 2,4,6,8,10) with high "number" indicating worse pain.	Approximately 1 hour prior to venipuncture and again immediately after venipuncture.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Scores	Changed in pre/post venipuncture anxiety scores using visual analogue scale where patients mark on a scale their value from 0-100mm.	Approximately 1 hour prior to venipuncture and again immediately after venipuncture.
Heart Rate	Change in HR for patients on cardiac monitor pre/post venipuncture	Approximately 1 hour prior to venipuncture and again immediate after venipuncture.
Level of simulator sickness	Level of simulator sickness with immersive VR distraction during venipuncture using serum sickness survey (4 questions 0-10 asking degree of head hurt, eye hurt, upset stomach and dizziness with 10 being worse outcome)	Approximately 1 hour prior to venipuncture and again immediately after venipuncture

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Courtney A McNamara, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: virtual reality
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural
• Other Study ID Numbers: 2020-11200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes