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OpenTrials
Completed

NCT Number: NCT07280910

Exploring Virtual Reality in Clinical Care - Impacts on Patient Distress, Parental Anxiety and Nurse Satisfaction

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

This retrospective study analyzes de-identified data from a nine-month quality improvement initiative to evaluate the impact of a custom VR intervention on pediatric preoperative anxiety, parental anxiety, and nurse satisfaction in a real clinical setting. The findings offer preliminary, practice-relevant evidence that VR can be a feasible, acceptable, and clinically meaningful non-pharmacologic tool in pediatric preoperative care, and they provide actionable insights to guide future implementation efforts and rigorous trials aimed at improving the hospital experience for children, families, and providers.

Who can participate

Healthy volunteers accepted: No

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

Pediatric Subjects

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients with developmental delays, head injuries, or seizures were excluded from the study.
  • Only those pediatric patients who met the inclusion criteria and did not exhibit the specified exclusion conditions were included. Data protection and de-identification procedures were rigorously applied throughout the study

Caregivers/Parents

Inclusion criteria

  • pediatric patients who were eligible and received VR during the QI initiative, aged 6-15 years

Exclusion criteria

  • N/A

Nurses

Inclusion criteria

  • nurses of pediatric patients who were eligible and received VR during the QI initiative, aged 6-15 years

Exclusion criteria

  • N/A

Treatment and study plan

Virtual Reality

Other

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.

Survey Responses/Parent Caregivers

Behavioral

Survey responses from parents regarding anxiety and satisfaction.

Survey Responses/Nurses

Behavioral

Survey responses from nurses regarding anxiety and satisfaction.

Primary outcomes

  1. Change in patient anxiety levels, as measured by heart rate

    Time frame: Before and after VR intervention, one visit only

    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.

  2. Change in patient anxiety levels, as measured by blood pressure

    Time frame: Before and after VR intervention, one visit only

    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.

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

    Time frame: Before and after VR intervention, one visit only

    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).

Secondary outcomes

  1. Parental anxiety levels

    Time frame: Before and after VR intervention, one visit only

    Change in parental anxiety levels, measured by pre- and post-intervention State-Trait Anxiety Inventory (STAI) scores. The State-Trait Anxiety Inventory (STAI) scoring involves summing the scores from the 40 items, each rated on a 4-point Likert scale, to assess state and trait anxiety. The higher the score, the higher the level of anxiety.

    • = Not at all
    • = Somewhat
    • = Moderately so
    • = Very much so

  2. Nurse satisfaction ratings

    Time frame: Before and after VR intervention, one visit only

    Nurse satisfaction ratings with the VR intervention, measured via survey responses. Nurse satisfaction with the VR intervention was measured using a brief, Likert-scale survey developed for this quality improvement project.

    Survey Format: A 5-point Likert scale was used for all items:

    • 1 = Very Dissatisfied / Very Difficult (bad)
    • 2 = Dissatisfied
    • 3 = Neutral
    • 4 = Satisfied
    • 5 = Very Satisfied / Very Easy to Use (good) Higher scores indicate better satisfaction and more straightforward implementation.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

Retrospective Observational Study Analyzing De-identified Data Originally Collected as Part of a Quality Improvement (QI) Initiative.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

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.

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