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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689868
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Samuel Rodriguez, Stanford University

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).

Condition or disease Intervention/treatment Phase
Anxiety Parents Language Behavioral: Virtual Reality Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Addressing Parental and Pediatric Anxiety Through Virtual Reality (VR) Intervention in (Limited-English Proficiency) LEP Populations
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 24, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Virtual Reality Behavioral: Virtual Reality
Virtual Reality headset with calming scenery

No Intervention: Control



Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689868


Contacts
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Contact: Ahtziri Fonseca, BS 6504970927 aef22011@stanford.edu
Contact: Fatima Rodriguez, MD, MPH

Locations
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United States, California
Lucile Packard Children's Hospital Stanford Recruiting
Palo Alto, California, United States, 94304
Contact: Ahtziri Fonseca         
Sub-Investigator: Fatima Rodriguez, MD, MPH         
Sponsors and Collaborators
Stanford University
Publications:
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Responsible Party: Samuel Rodriguez, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03689868    
Other Study ID Numbers: 46551
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samuel Rodriguez, Stanford University:
virtual reality
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders