Clinical trial NCT04479735: Virtual Reality Goggle Utilization for Venipuncture Distraction
Official title: Optimizing the Patient Experience: Virtual Reality Goggle Utilization for Venipuncture Distraction - Can we Decrease Anxiety and Pain During This Common Procedure?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Procedural
Keywords: virtual reality
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized non blinded study
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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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Primary outcomes:
measure: Change in Perceived Pain Scale
timeFrame: Approximately 1 hour prior to venipuncture and again immediately after venipuncture
Secondary outcomes:
measure: Change in Anxiety Scores
timeFrame: Approximately 1 hour prior to venipuncture and again immediately after venipuncture
measure: Change in Heart Rate
timeFrame: Approximately 1 hour prior to venipuncture and again immediate after venipuncture
measure: Change in Level of simulator sickness
timeFrame: Approximately 1 hour prior to venipuncture and again immediately after venipuncture
measure: Pre-venipuncture anxiety scores in participants with prior hospitalizations or prior medical problems.
timeFrame: Baseline
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Courtney A McNamara, MD
role: PRINCIPAL_INVESTIGATOR
References: