Limited-English Proficiency (LEP) Virtual Reality (VR) Study
Addressing Parental and Pediatric Anxiety Through Virtual Reality (VR) Intervention in (Limited-English Proficiency) LEP Populations
1 other identifier
interventional
44
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable anxiety
Started Aug 2018
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2018
CompletedFirst Submitted
Initial submission to the registry
September 27, 2018
CompletedFirst Posted
Study publicly available on registry
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2021
CompletedApril 20, 2023
April 1, 2023
2.9 years
September 27, 2018
April 19, 2023
Conditions
Keywords
Outcome Measures
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)
Duration of intervention, approximately 20-30 minutes
Study Arms (2)
Virtual Reality
EXPERIMENTALControl
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304, United States
Related Publications (2)
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.
PMID: 24882604BACKGROUNDFabiyi 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.
PMID: 22962543BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
September 27, 2018
First Posted
October 1, 2018
Study Start
August 24, 2018
Primary Completion
July 9, 2021
Study Completion
July 9, 2021
Last Updated
April 20, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share