Virtual Reality Goggle Utilization for Venipuncture Distraction

NCT04479735 | Completed

• 1 other identifier: 2020-11200
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Procedural

Keywords

virtual reality

Outcome Measures

Primary Outcomes (1)

• Change in Perceived Pain Scale

  Change in perceived pain from pre-venipuncture to post-venipuncture (during the blood draw) will be assessed using the Wong-Baker FACES Pain Rating scale. Children, or parents on behalf of children, will be asked to communicate the severity of the pain the child is experiencing using the FACES scale which contains a series of 6 different facial expressions correlated to numbers (i.e., 0, 2, 4, 6, 8, 10) ranging from a happy face at "0" indicating "no hurt" to a crying face at "10" indicating "hurts worst." Higher scale scores signify worse pain severity. Change in group mean FACES scale scores will be summarized by study arm and subsequently analyzed using Wilcoxon signed rank test for paired data.

  Approximately 1 hour prior to venipuncture and again immediately after venipuncture

Secondary Outcomes (4)

• Change in Anxiety Scores

  Approximately 1 hour prior to venipuncture and again immediately after venipuncture

• Change in Heart Rate

  Approximately 1 hour prior to venipuncture and again immediate after venipuncture

• Change in Level of simulator sickness

  Approximately 1 hour prior to venipuncture and again immediately after venipuncture

• Pre-venipuncture anxiety scores in participants with prior hospitalizations or prior medical problems.

  Baseline

Study Arms (2)

VR goggle with venipuncture

EXPERIMENTAL

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

no VR goggle with venipuncture

NO INTERVENTION

Patients will receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture but NO virtual reality goggles.

Interventions

Virtual Reality Goggles DEVICE

Virtual reality goggles will placed at least 2 min prior to venipuncture to deteremine if it mitigates perceived anxiety or perceived pain scores.

VR goggle with venipuncture

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• KindVR: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Gold JI, SooHoo M, Laikin AM, Lane AS, Klein MJ. Effect of an Immersive Virtual Reality Intervention on Pain and Anxiety Associated With Peripheral Intravenous Catheter Placement in the Pediatric Setting: A Randomized Clinical Trial. JAMA Netw Open. 2021;4(8):e2122569. doi:10.1001/jamanetworkopen.2021.22569

  BACKGROUND

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Courtney A McNamara, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized non blinded study

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: July 16, 2021
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)