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临床试验/NCT07280910
NCT07280910已完成不适用

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

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
1
主要终点
Change in patient anxiety levels, as measured by heart rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Change in patient anxiety levels, as measured by heart rate

时间窗: 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.

Change in patient anxiety levels, as measured by blood pressure

时间窗: 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.

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

时间窗: 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).

次要结局

  • Parental anxiety levels(Before and after VR intervention, one visit only)
  • Nurse satisfaction ratings(Before and after VR intervention, one visit only)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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