CClinicalTrials.gg
CompletedNCT03689868Updated Apr 20, 2023

Limited-English Proficiency (LEP) Virtual Reality (VR) Study

An interventional study of Virtual Reality in Anxiety, Parents and Language, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged Up to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-20.

Sponsored by Stanford University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
Up to 99 Years
Sex
All
01

Study summary

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations with limited English proficiency (LEP).

02

Conditions studied

  • Anxiety
  • Parents
  • Language

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Keywords

  • virtual reality
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 44 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Ages 0-99 (Child participants will be ages 0 to 17. Parents of children of any age may also be enrolled)
  • Able to consent
  • Self-identified as having a limited English proficiency or English-proficiency

Exclusion criteria

Exclusion Criteria:

  • People who do not consent
  • Significant Cognitive Impairment
  • History of Severe Motion Sickness
  • Current Nausea
  • Seizures
  • Visual Problems
  • Patients whose children are clinically unstable or require urgent/emergent intervention
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Virtual Reality

    Behavioral: Virtual Reality

  • No intervention
    Control

Interventions

  • BehavioralVirtual Reality

    Virtual Reality headset with calming scenery

06

What researchers measure

Primary outcomes

  1. Procedural-Related Anxiety

    Validated questionnaires regarding anxiety will be administers pre- and post-intervention (i.e virtual reality) and compared to those in the control arm (i.e no virtual reality)

    Time frame: Duration of intervention, approximately 20-30 minutes

07

Study locations

1 site
  • Lucile Packard Children's Hospital Stanford
    Palo Alto, California 94304, United States
08

References and documents

Publications

  • West AM, Bittner EA, Ortiz VE. The effects of preoperative, video-assisted anesthesia education in Spanish on Spanish-speaking patients' anxiety, knowledge, and satisfaction: a pilot study. J Clin Anesth. 2014 Jun;26(4):325-9. doi: 10.1016/j.jclinane.2013.12.008. Epub 2014 Jun 2. PubMed 24882604 ↗
  • Fabiyi C, Rankin K, Norr K, Shapiro N, White-Traut R. Anxiety among Black and Latina Mothers of Premature Infants at Social-Environmental Risk. Newborn Infant Nurs Rev. 2012 Sep 1;12(3):132-140. doi: 10.1053/j.nainr.2012.06.004. PubMed 22962543 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03689868
Lead sponsor
Stanford University
Responsible party
Samuel Rodriguez (Clinical Assistant Professor, Stanford University) — Principal investigator
First posted
Oct 1, 2018
Start date
Aug 24, 2018
Primary completion
Jul 9, 2021
Completion
Jul 9, 2021
Last update
Apr 20, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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