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OpenTrials
Completed

NCT Number: NCT03689868

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

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).

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Key information

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Virtual reality

Behavioral

Virtual Reality headset with calming scenery

Primary outcomes

  1. Procedural-Related Anxiety

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

    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)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Addressing Parental and Pediatric Anxiety Through Virtual Reality (VR) Intervention in (Limited-English Proficiency) LEP Populations

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2018
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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