Virtual Reality Goggle Utilization for Venipuncture Distraction

Pain, Procedural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04479735
• Other study ID #: 2020-11200
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2021
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Montefiore Medical Center
• Contact: Courtney A McNamara, MD
• Phone: 540 514 4389
• Email: comcnama[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

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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Related Conditions & MeSH terms

• Pain, Procedural

Intervention

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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Heart Rate	Change in HR for patients on cardiac monitor pre/post venipuncture	Approximately 1 hour prior to venipuncture and again immediate after venipuncture.
Secondary	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