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

NCT ID: NCT03689868

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-24

Study Completion Date

2021-07-09

Brief Summary

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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).

Detailed Description

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Conditions

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Anxiety Parents Language

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Virtual Reality

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type BEHAVIORAL

Virtual Reality headset with calming scenery

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality

Virtual Reality headset with calming scenery

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Samuel Rodriguez

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24882604 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22962543 (View on PubMed)

Other Identifiers

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46551

Identifier Type: -

Identifier Source: org_study_id

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