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

Primary Purpose

Anxiety, Parents, Language

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring virtual reality

Eligibility Criteria

undefined - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lucile Packard Children's Hospital Stanford

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality

Control

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
September 27, 2018
Last Updated
April 19, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03689868
Brief Title
Limited-English Proficiency (LEP) Virtual Reality (VR) Study
Official Title
Addressing Parental and Pediatric Anxiety Through Virtual Reality (VR) Intervention in (Limited-English Proficiency) LEP Populations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 24, 2018 (Actual)
Primary Completion Date
July 9, 2021 (Actual)
Study Completion Date
July 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Parents, Language
Keywords
virtual reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality
Intervention Description
Virtual Reality headset with calming scenery
Primary Outcome Measure Information:
Title
Procedural-Related Anxiety
Description
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Lucile Packard Children's Hospital Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24882604
Citation
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.
Results Reference
background
PubMed Identifier
22962543
Citation
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.
Results Reference
background

Learn more about this trial

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

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