Treatment of Parental Anxiety Virtual Reality (VR)
1 other identifier
interventional
485
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable anxiety
Started Jun 2023
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2023
CompletedFirst Posted
Study publicly available on registry
February 15, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2025
CompletedFebruary 17, 2026
February 1, 2026
2.4 years
February 6, 2023
February 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Anxiety levels
Anxiety level measured by a Visual Analogue Scale - Anxiety (VAS-A) ranging from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels.
immediately after the intervention
Secondary Outcomes (4)
State-Trait Anxiety Inventory
baseline, immediately after the intervention
Modified Pain Catastrophizing Scale
immediately after intervention
Device satisfaction
immediately after intervention
Procedural-Related Anxiety
Duration of intervention, approximately 20-30 minutes
Study Arms (2)
Virtual Reality
EXPERIMENTALParticipants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes
Control
NO INTERVENTIONNo intervention (i.e. virtual reality headset) will be applied to the participant.
Interventions
Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes
Eligibility Criteria
You may qualify if:
- Ages 18-99 (Parents whose children is hospitalized)
- Able to consent
- Parents whose child is undergoing various procedures at LPCH and Stanford Hospital and Clinics.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lucile Parkard Children's Hospital
Stanford, California, 94304, United States
Related 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.
PMID: 35402359BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
February 6, 2023
First Posted
February 15, 2023
Study Start
June 1, 2023
Primary Completion
October 13, 2025
Study Completion
October 13, 2025
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share