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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03689868
Other study ID # 46551
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 24, 2018
Est. completion date July 9, 2021

Study information

Verified date April 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date July 9, 2021
Est. primary completion date July 9, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual Reality
Virtual Reality headset with calming scenery

Locations

Country Name City State
United States Lucile Packard Children's Hospital Stanford Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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