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NCT05729347 Clinical Trial

Treatment of Parental Anxiety Virtual Reality (VR)

Anxiety Clinical Trial

Official title:
Treatment of Parental Anxiety With Virtual Reality (VR): A Prospective, Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05729347
Other study ID # 69068
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date May 31, 2025

Study information
Verified date April 2024
Source Stanford University
Contact Thomas J Caruso, MD
Phone 650-723-5728
Email tjcaruso@stanford.edu
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

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 99 Years
Eligibility Inclusion Criteria: - Ages 18-99 (Patient's parents will be enrolled) - Able to consent 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 headset with calming scenery
Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes

Locations
Country Name City State
United States Lucile Parkard Children's Hospital Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chang ZY, Kang GC, Koh EYL, Fong RJK, Tang J, Goh CK, Tan NC. Immersive Virtual Reality in Alleviating Pain and Anxiety in Children During Immunization in Primary Care: A Pilot Randomized Controlled Trial. Front Pediatr. 2022 Mar 25;10:847257. doi: 10.3389/fped.2022.847257. eCollection 2022. — 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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