Treatment of Parental Anxiety Virtual Reality (VR)

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

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

Study Overview

• Status: Completed
• Conditions: Anxiety; Parents; Virtual Reality
• Intervention / Treatment: Behavioral: Virtual Reality headset with calming scenery

• Study Type: Interventional
• Enrollment (Actual): 485
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Lucile Parkard Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes	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
No Intervention: Control; No intervention (i.e. virtual reality headset) will be applied to the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Assessed in participants enrolled in both general hospital setting and specifically in the Emergency Department setting.	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Modified Pain Catastrophizing Scale	Modified Pain Catastrophizing Scale(PCS); It is a self-report measure adapted from the Adult Pain Catastrophizing Scale used to assess negative thinking associated with pain. It contains 3 items rated on a 5-point scale ranging from 0 = "not at all" to 4 = "very much".	immediately after intervention
State-Trait Anxiety Inventory	The State-Trait Anxiety Inventory (STAI) is a validated self-report questionnaire consisting of two subscales that measure state anxiety (temporary condition) and trait anxiety (general tendency). Each subscale contains 20 items rated on a 4-point Likert scale. Scores range from 20 to 80 per subscale, with higher scores indicating greater anxiety. Assessed in participants enrolled in both general hospital setting and specifically in the Emergency Department setting.	baseline, immediately after the intervention
Device satisfaction	To evaluate the overall impact of device satisfaction, participants will complete the self-developed satisfaction survey. Participants will rank each factor on a Likert scale from 1 = not at all to 5 = a lot. Assessed in participants enrolled in both general hospital setting and specifically in the Emergency Department setting.	immediately after intervention

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): October 13, 2025
• Study Completion (Actual): October 13, 2025

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 69068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No