Anxiety Clinical Trial
Official title:
Addressing Parental and Pediatric Anxiety Through Virtual Reality (VR) Intervention in (Limited-English Proficiency) LEP Populations
| 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 |
| Verified date | April 2023 |
| Source | Stanford University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Lucile Packard Children's Hospital Stanford | Palo Alto | California |
| Lead Sponsor | Collaborator |
|---|---|
| Stanford University |
United States,
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
| 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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