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Pain, ProceduralNCT04479735

Virtual Reality Goggle Utilization for Venipuncture Distraction

A study testing Virtual Reality Goggles in people with Pain, Procedural, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 21 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Procedural
What is being tested?
Virtual Reality Goggles
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteUnited States
Study dates
16 Jul 2021to 20 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 21 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Virtual Reality Goggles
Keywords
virtual reality
Medical subject headings
Pain, Procedural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality GogglesDevice

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

Study groups in NCT04479735
Study groupRoleWhat they receive
VR goggle with venipunctureExperimentalVirtual 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.
Receives: Device: Virtual Reality Goggles
no VR goggle with venipunctureNo interventionPatients will receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture but NO virtual reality goggles.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Approximately 1 hour prior to venipuncture and again immediately after venipuncture

Secondary outcomes (4)

  1. Change in Anxiety Scores

    Change in anxiety from pre-venipuncture to post-venipuncture (during the blood draw) will be assessed using the Visual Analog Scale (VAS). Children, or parents on behalf of children, will be asked to estimate the level of anxiety the child is having by marking their estimate on a visual 0-to-100 millimeter (mm) line ranging from "0" (=Not at all Anxious) to "100" (=Extremely Anxious). The line increases by increments of "1" from left to right. A score of ≥ 30mm is considered anxious. Change in anxiety scores will be summarized by study arm using basic descriptive statistics and subsequently analyzed using Wilcoxon signed rank test for paired data.

    Measured: Approximately 1 hour prior to venipuncture and again immediately after venipuncture

  2. Change in Heart Rate

    Change in HR from pre-venipuncture to post-venipuncture will be evaluated for those patients on a cardiac monitor. Increased heart rate can be associated with increases in pain and anxiety. Group mean changes in heart will be summarized by study arm and subsequently analyzed using Wilcoxon signed rank test for paired data.

    Measured: Approximately 1 hour prior to venipuncture and again immediate after venipuncture

  3. Change in Level of simulator sickness

    Change in Level of simulator sickness from pre-venipuncture (pre-placement of Virtual Reality goggles) to post-venipuncture (removal of VR goggles) will be assessed using a Simulator Sickness Questionnaire. The survey consists for 4 questions related to the possible side effects of using the VR goggles. Children, or parents on behalf of children, will be asked to respond to the following 4 questions on a scale ranging from 1-10: Does your head hurt? Do your eyes hurt? Do you have an upset stomach? Do you feel dizzy? Total scores will be summed for an overall possible scoring range of 4-40 with higher scores indicating worse sickness symptoms. Change in simulator sickness scores will be summarized by study arm.

    Measured: Approximately 1 hour prior to venipuncture and again immediately after venipuncture

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

    Level of pre venipuncture anxiety scores in participants with prior hospitalizations or prior medical problems will be evaluated. Anxiety scores will be collected using the VAS tool. Children, or parents on behalf of children, will be asked to estimate the level of anxiety the child is having by marking their estimate on a visual 0-to-100mm line ranging from "0" (=Not at all Anxious) to "100" (=Extremely Anxious). The line increases by increments of "1" from left to right. A score of ≥ 30mm is considered anxious. Prior hospitalization data and prior medical problem information will be extracted via chart review. Anxiety scores will be summarized by study arm using basic descriptive statistics. An independent t test will be used to asses whether anxiety scores are normally distributed or Mann U test if not normally distributed.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2020
  2. Study start16 Jul 2021
  3. Primary completion20 Oct 2025
  4. Study completion20 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized non blinded study
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04479735
Sponsor's protocol ID
2020-11200
Status last verified
Feb 2026
First submitted
16 Jul 2020
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 Aug 2;4(8):e2122569. doi: 10.1001/jamanetworkopen.2021.22569.

    PubMed 34432011

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Goggles in people with Pain, Procedural, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Perceived Pain Scale (time frame: Approximately 1 hour prior to venipuncture and again immediately after venipuncture). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04479735, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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