NCT07280910

Brief Summary

Prior experience with virtual reality (VR) in clinical care has demonstrated its potential to reduce patient anxiety and distress, particularly in pediatric settings. VR has been shown to effectively decrease preoperative anxiety in children undergoing various medical procedures, including IV catheter replacement, blood draws, and improve their compliance with anesthesia and overall procedural experiences. Limited evidence exists regarding the impact of VR on the broader care environment, including parental anxiety and nursing satisfaction in pediatric settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

December 1, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

Virtual RealityQuality ImprovementProtected Health InformationHeart RateBlood PressureState-Trait Anxiety Inventory

Outcome Measures

Primary Outcomes (3)

  • Change in patient anxiety levels, as measured by heart rate

    Change in patient anxiety levels, as measured by heart rate, before and after VR intervention. Baseline heart rate will be compared to the heart rate after the intervention.

    Before and after VR intervention, one visit only

  • Change in patient anxiety levels, as measured by blood pressure

    Change in patient anxiety levels, as measured by blood pressure, before and after VR intervention. Baseline blood pressure will be compared to the blood pressure after the intervention.

    Before and after VR intervention, one visit only

  • Change in patient anxiety levels, as measured by distress/fear scores

    Change in patient anxiety levels, as measured by distress/fear scores before and after VR intervention Baseline distress/fear scores will be compared to the distress/fear scores after the intervention. Using the Children's Fear Scale (CFS) (0-4): * 0 = no fear (good) * 4 = very high fear (bad) . Higher scores indicate worse anxiety. Anxiety levels were measured immediately before and immediately after the VR intervention).

    Before and after VR intervention, one visit only

Secondary Outcomes (2)

  • Parental anxiety levels

    Before and after VR intervention, one visit only

  • Nurse satisfaction ratings

    Before and after VR intervention, one visit only

Study Arms (3)

Pediatric Patients

Pediatric patients receiving VR interventions (6-15 years)

Other: Virtual Reality

Parent Caregivers

Parents of Pediatric patients receiving VR interventions (6-15 years)

Behavioral: Survey Responses/Parent Caregivers

Nurses

The nursing staff are involved in the care process of the Pediatric patients receiving VR interventions (6-15 years)

Behavioral: Survey Responses/Nurses

Interventions

Administered as part of a QI initiative aimed at reducing anxiety in pediatric patients during clinical care. The intervention involved using a VR system to provide a distraction and relaxation tool during routine procedures. This approach is consistent with recent research showing that VR can be an effective tool for reducing pain and anxiety in pediatric patients undergoing medical procedures. Retrospective data collection.

Pediatric Patients

Survey responses from parents regarding anxiety and satisfaction.

Parent Caregivers

Survey responses from nurses regarding anxiety and satisfaction.

Nurses

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study involved pediatric patients who received VR intervention as part of the original QI initiative. Data protection and de-identification procedures were rigorously applied throughout the study

You may qualify if:

  • pediatric patients who received VR intervention as part of the original QI initiative.
  • pediatric patients who were eligible and received VR during the QI initiative aged 6-15 years.

You may not qualify if:

  • Patients with developmental delays, head injuries, or seizures were excluded from the study.
  • Caregivers/Parents
  • \- pediatric patients who were eligible and received VR during the QI initiative, aged 6-15 years
  • \- N/A
  • Nurses
  • nurses of pediatric patients who were eligible and received VR during the QI initiative, aged 6-15 years
  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Nurses

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Dayanjan Wijesinghe

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 12, 2025

Study Start

October 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations