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Effectiveness of Virtual Reality in Reducing Anxiety and Pain During the First Postoperative Orthopedic Dressing Change in Pediatric Patients (VR OrthoPed)

2026年7月22日 更新者:Gianluca Catania

Effectiveness of Virtual Reality in Reducing Anxiety and Pain During the First Postoperative Orthopedic Dressing Change in Pediatric Patients: A Randomized Controlled Trial

The goal of this randomized clinical trial is to learn whether immersive virtual reality can reduce anxiety and pain in children and adolescents undergoing postoperative orthopedic dressing changes. The main questions it aims to answer are:

Does immersive virtual reality reduce anxiety during postoperative dressing changes compared with standard care?

Does immersive virtual reality reduce pain and physiological signs of distress, such as changes in heart rate and respiratory rate?

Researchers will compare participants who use an immersive virtual reality headset during the dressing change with participants who receive standard care without virtual reality.

Participants will:

Be randomly assigned to the virtual reality group or the standard care group

Undergo a postoperative orthopedic dressing change with or without immersive virtual reality

Report their anxiety and pain before and after the procedure

Have their heart rate and respiratory rate measured before, during, and after the dressing change

研究概览

详细说明

Postoperative orthopedic dressing changes can cause anxiety, pain, and physiological distress in pediatric patients. Immersive virtual reality may provide a non-pharmacological form of distraction by directing the participant's attention away from the clinical procedure and toward an engaging virtual environment.

This randomized clinical trial was conducted in a pediatric orthopedic unit to evaluate the use of immersive virtual reality during postoperative dressing changes. After enrollment and baseline assessment, participants were randomly assigned to receive either immersive virtual reality in addition to the usual dressing procedure or standard care alone.

Participants assigned to the virtual reality group wore a head-mounted display and viewed an immersive virtual environment during the dressing change. Participants assigned to the standard care group underwent the same clinical procedure according to usual practice without virtual reality. The dressing change was performed by the clinical team in accordance with routine postoperative care.

Anxiety, pain, heart rate, respiratory rate and peripheral oxygen saturation were assessed at predefined time points before, during, and after the procedure, as applicable. These measurements were used to examine whether immersive virtual reality was associated with reduced psychological and physiological distress during the dressing change.

The study was designed to provide evidence on the potential usefulness of immersive virtual reality as a non-drug supportive intervention during postoperative procedures in pediatric orthopedic care.

研究类型

介入性

注册 (实际的)

48

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Liguria
      • Genoa、Liguria、意大利、16132
        • Dipartimento di scienze della salute, DISSAL - UNIGE

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

Inclusion Criteria

  • Patients aged 6-18 years.
  • Undergoing corrective orthopedic surgery for congenital or acquired limb deformities, with or without external fixation devices, or spinal arthrodesis for scoliosis or spondylolisthesis.
  • Undergoing the first postoperative wound dressing procedure.
  • Written informed consent obtained from a parent or legal guardian.
  • Assent obtained from the participant, when appropriate. Exclusion Criteria
  • Neurological disorders.
  • History of epilepsy.
  • Prematurity.
  • Sensory impairments preventing the use of the virtual reality headset.
  • Cognitive impairments preventing the use of the virtual reality headset.
  • Motor limitations preventing the use of the virtual reality headset.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Immersive Virtual Reality Plus Standard Care
Participants received the first postoperative orthopedic dressing procedure according to routine clinical practice while using an immersive virtual reality headset. The headset displayed an immersive virtual environment throughout the dressing procedure as a non-pharmacological distraction intervention. Standard clinical monitoring and nursing care were provided.
Participants used an immersive virtual reality headset during the first postoperative orthopedic dressing procedure. The headset presented an immersive virtual environment intended to divert attention from the clinical procedure and reduce anxiety, pain, and physiological stress. The virtual reality intervention was provided in addition to the routine postoperative dressing care delivered by the clinical team. The headset was worn during the dressing procedure and removed after its completion.
有源比较器:Standard Care Alone
Participants received the first postoperative orthopedic dressing procedure according to routine clinical practice without the use of immersive virtual reality. Standard clinical monitoring and nursing care were provided.
Participants underwent the first postoperative orthopedic dressing procedure according to routine clinical practice without the use of immersive virtual reality. Standard nursing care and clinical monitoring were provided throughout the procedure.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Anxiety Assessed Using the Visual Analogue Scale for Anxiety
大体时间:Immediately before and immediately after the first postoperative orthopedic dressing procedure
Anxiety was assessed using the Visual Analogue Scale for Anxiety (VAS-A), a 100 mm horizontal scale ranging from 0, indicating no anxiety, to 100, indicating maximum anxiety. Higher scores indicate greater anxiety. Change in anxiety was calculated as the score immediately after the procedure minus the score immediately before the procedure. A negative change score indicates a reduction in anxiety.
Immediately before and immediately after the first postoperative orthopedic dressing procedure

次要结果测量

结果测量
措施说明
大体时间
Change in Pain Intensity Assessed Using the Faces Pain Scale
大体时间:Immediately before and immediately after the first postoperative orthopedic dressing procedure
Pain intensity in participants aged 6 to 10 years was assessed immediately before and immediately after the first postoperative orthopedic dressing procedure using the Faces Pain Scale. Higher scores indicate greater pain intensity. Change in pain was calculated as the post-procedure score minus the pre-procedure score.
Immediately before and immediately after the first postoperative orthopedic dressing procedure
Change in Pain Intensity Assessed Using the Numeric Rating Scale
大体时间:Immediately before and immediately after the first postoperative orthopedic dressing procedure.
Pain intensity in participants older than 10 years was assessed immediately before and immediately after the first postoperative orthopedic dressing procedure using the Numeric Rating Scale (0-10). Higher scores indicate greater pain intensity. Change in pain was calculated as the post-procedure score minus the pre-procedure score.
Immediately before and immediately after the first postoperative orthopedic dressing procedure.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年9月1日

初级完成 (实际的)

2025年12月31日

研究完成 (实际的)

2025年12月31日

研究注册日期

首次提交

2026年7月14日

首先提交符合 QC 标准的

2026年7月22日

首次发布 (实际的)

2026年7月27日

研究记录更新

最后更新发布 (实际的)

2026年7月27日

上次提交的符合 QC 标准的更新

2026年7月22日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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