Skip to main content
OpenTrials
Completed

NCT Number: NCT05729347

Treatment of Parental Anxiety Virtual Reality (VR)

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. The study will be conducted in the general inpatient area, Emergency Department and Heart Center.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Parents State Anxiety Trait Anxiety Virtual Reality

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Parkard Children's Hospital

Stanford, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality headset with calming scenery

Behavioral

Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes

Primary outcomes

  1. Anxiety levels (General inpatient area, Emergency Department)

    Time frame: Baseline, immediately after the intervention

    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.

  2. State-Trait Anxiety Inventory [Heart Center]

    Time frame: baseline, immediately after the intervention

    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 specifically in the Heart Center.

Secondary outcomes

  1. Anxiety levels (Heart Center)

    Time frame: Baseline, immediately after the intervention

    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 specifically in the Heart Center setting.

  2. State-Trait Anxiety Inventory (General inpatient area, Emergency Department)

    Time frame: baseline, immediately after the intervention

    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.

  3. Caregiver Device satisfaction scale (investigator-developed Satisfaction Questionnaire)

    Time frame: immediately after intervention

    To evaluate the overall impact of device satisfaction, participants will complete the self-developed satisfaction survey containing 5 items. Participants will rank each factor on a Likert scale from 1 = not at all to 5 = a lot.

    Assessed in participants enrolled in general hospital setting and specifically in the Emergency Department setting and Heart Center setting.

  4. Caregiver-reported acceptability and tolerability of virtual reality (investigator-developed VR Questionnaire)

    Time frame: immediately after virtual reality intervention

    Caregiver response to the virtual reality intervention was assessed with an investigator-developed questionnaire administered in English or Spanish after the VR session. Four items assessed relaxation, distraction, willingness to use VR again for a future procedure or hospitalization, and interest in VR; each is scored on a 5-point Likert scale from 1 ("Do not agree at all"/"No interest at all") to 5 ("Completely agree"/"Completely interested"), with higher scores indicating greater acceptability.

    A final checklist item asked caregivers to indicate whether they experienced any of the following during the virtual reality experience, selecting all that applied: nausea, dizziness, headache, disorientation, eye strain, none of the above, or other.

    Assessed in participants enrolled in general hospital setting and Heart Center setting.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2023
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.