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Virtual Reality-Assisted Cast Application in Children With Forearm Fractures (VR-CAST)

2026年7月1日 更新者：Lezgin Mert、Başakşehir Çam & Sakura City Hospital

Does Virtual Reality Reduce Pain, Anxiety, Physiologic Stress, and Return-Visit Fear During Pediatric Forearm Casting? A Randomized Controlled Trial

This prospective randomized controlled trial will evaluate whether virtual reality can reduce procedural distress in children undergoing cast application for forearm fractures. Children will be assigned to either a virtual reality group or a standard care group. In the virtual reality group, children will watch a 3-minute child-friendly animated educational video using a VR headset during cast application. The video explains the casting procedure, how to protect the cast, and what the child should do after the cast is applied.

The study will compare pain, anxiety, heart rate response, caregiver anxiety, and procedure-related fear between the two groups. The casting team will assess the child during the procedure. One day after cast application, each child will undergo an approximately 30-minute evaluation by a child psychiatry clinician who is blinded to group allocation. This follow-up assessment will evaluate the child's current anxiety, anxiety related to the cast experience, fear of returning to the hospital or doctor, and fear-related behaviors after the procedure.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Forearm fractures are common injuries in children and frequently require cast immobilization. Although cast application is a routine orthopedic procedure, children may experience pain, anxiety, fear, and physiologic stress during the procedure. In some children, this experience may also lead to fear of returning to the hospital or doctor, sometimes referred to as doctor-related or white coat-related fear.

Virtual reality may help children during medical procedures by providing immersive visual and auditory distraction. In addition, an age-appropriate educational video may reduce uncertainty by explaining what will happen during the procedure and how the child should care for the cast afterward.

This study is designed as a prospective, randomized, parallel-group clinical trial. Children with forearm fractures requiring cast application will be randomized into two groups: a virtual reality group and a standard care group. Children in the virtual reality group will wear a Meta Quest 3 headset during cast application and watch a 3-minute child-friendly animated educational video generated using Google Flow. The video explains the cast application process, cast protection, and post-cast care instructions. Children in the standard care group will undergo routine cast application without virtual reality. Apart from the virtual reality intervention, all clinical care will be the same between the two groups.

During cast application, the orthopedic casting team will record procedural pain, procedural anxiety, heart rate before the procedure, mean heart rate during the procedure, heart rate after a 2-minute recovery period, procedure duration, whether the virtual reality headset was removed, and whether nausea, dizziness, or discomfort occurred. Caregivers will also rate the child's anxiety, their own anxiety, and the child's pain before and after the procedure.

One day after cast application, each child will undergo an approximately 30-minute follow-up assessment by a child psychiatry clinician who is blinded to group allocation. Children and caregivers will be instructed not to disclose whether virtual reality was used. This blinded assessment will evaluate the child's current anxiety, anxiety related to the cast experience, anxiety while returning to the hospital or doctor, reluctance to return to the doctor, fear-related behaviors at home such as crying or sleep disturbance, and distress when remembering the cast procedure.

The primary objective of the study is to determine whether virtual reality reduces cast-related anxiety and subsequent doctor-related fear after cast application. Secondary objectives include evaluating the effect of virtual reality on procedural pain, procedural anxiety, heart rate response, caregiver anxiety, procedure duration, virtual reality tolerability, and caregiver preference for future use of virtual reality during similar procedures.

研究类型

介入性

注册 (估计的)

120

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。

学习联系方式

学习地点

  • 土耳其（türkiye）
    • Istanbul
      • Istanbul、Istanbul、土耳其（türkiye）、34010
        • 招聘中
        • Basaksehir Çam Ve Sakura City Hospital
        • 接触：

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

接受健康志愿者

不

描述

Inclusion Criteria:

  • Children aged 4 to 15 years.
  • Diagnosis of an isolated forearm fracture requiring cast application with traction (greenstick injuries plastic deformation if NOT over 20 degrees bayonet apposition ok if <10 years and growth remains)
  • First cast application for the current fracture episode.
  • Typically developing children without a known developmental delay or cognitive impairment that would prevent participation in the study assessments.
  • Ability of the child to understand age-appropriate instructions and respond to pain, anxiety, and fear-related assessments with caregiver assistance when necessary.
  • At least one upper extremity free of immobilization, allowing heart rate assessment during the procedure.
  • Parent or legal guardian able to provide written informed consent.
  • Child assent when appropriate according to age and local ethics committee requirements.
  • Ability and willingness of the child and caregiver to attend an approximately 30-minute blinded child psychiatry assessment 1 day after cast application.

Exclusion Criteria:

  • Open forearm fracture.
  • Multiple trauma or an additional painful injury that may affect pain, anxiety, or fear assessment.
  • Need for emergency surgery, procedural sedation, or general anesthesia during cast application.
  • Previous participation in this study.
  • Known developmental delay, cognitive impairment, autism spectrum disorder with inability to complete study assessments, or severe psychiatric disorder that may interfere with questionnaire-based evaluation.
  • Known epilepsy, photosensitive seizure disorder, severe motion sickness, vestibular disorder, or any condition considered unsafe for VR headset use.
  • Visual or hearing impairment preventing use of the VR intervention or completion of the assessments.
  • Head, face, or scalp injury preventing safe or comfortable use of a VR headset.
  • Nausea, dizziness, or severe discomfort before the procedure that would prevent VR use.
  • Refusal of the child or caregiver to participate.
  • Inability to complete the 1-day child psychiatry follow-up assessment.

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：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Virtual Reality-Assisted Cast Application
Children in this group will undergo cast application while watching a 3-minute child-friendly educational animated video through a VR headset. The video explains the cast application procedure, cast protection, and post-cast care instructions. Apart from the VR intervention, routine orthopedic care will be provided.
行为的：Virtual Reality-Based Educational Animation
Children assigned to the virtual reality group will watch a 3-minute child-friendly educational animated video through a VR headset during cast application. The video explains the cast application procedure, cast protection, and post-cast care instructions. The intervention is intended to reduce procedural distress through immersive visual and auditory distraction and age-appropriate education.
有源比较器：Standard Cast Application
Children in this group will undergo routine cast application without virtual reality. Standard verbal explanation and routine orthopedic care will be provided by the casting team.
其他：Standard Care
Children assigned to the control group will undergo routine cast application without virtual reality. Standard verbal explanation and routine orthopedic care will be provided by the casting team.

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
Child Psychiatry-Assessed Cast Experience Anxiety Score at 1 Day
大体时间：1 day after cast application
Cast-related fear and anxiety will be assessed 1 day after cast application by a child psychiatry clinician blinded to group allocation using a structured questionnaire. The assessment will evaluate the child's fear or anxiety related to the cast experience, reluctance to return to the doctor or hospital, fear-related behaviors at home such as crying or sleep disturbance, and distress when remembering the cast procedure.
1 day after cast application

次要结果测量

结果测量
措施说明
大体时间
Procedural Anxiety Score During Cast Application
大体时间：During cast application
The orthopedic casting team will assess the child's anxiety during cast application using a 0-100 score, where higher scores indicate greater procedural anxiety.
During cast application
Procedural Pain Score During Cast Application
大体时间：During cast application
The orthopedic casting team will assess the child's pain during cast application using a 0-10 score, where higher scores indicate greater procedural pain.
During cast application
Change in Heart Rate During Cast Application
大体时间：Before, during, and 2 minutes after cast application
Heart rate will be recorded before cast application, during the procedure, and after a 2-minute recovery period. Changes in heart rate from baseline to the procedural and recovery periods will be compared between groups.
Before, during, and 2 minutes after cast application
Procedure Duration
大体时间：During cast application
The duration of cast application will be recorded in minutes from the start of the cast application procedure to completion of the procedure. Procedure duration will be compared between the virtual reality group and the standard care group.
During cast application
Physician-Rated Procedural Difficulty Score
大体时间：During cast application
The physician performing the cast application will rate the procedural difficulty using a 0-10 score according to the child's cooperation, movement, crying, fear response, and overall behavioral reaction during cast application. Higher scores indicate greater procedural difficulty.
During cast application
Child Behavioral Response During Cast Application
大体时间：During cast application
The child's behavioral response during cast application will be assessed by the casting physician. The assessment will include cooperation, crying, avoidance behavior, agitation, movement during the procedure, and overall tolerance of the cast application.
During cast application
Caregiver-Rated Child Anxiety
大体时间：Immediately after cast application
Caregivers will rate how anxious they think their child is using a 0-100 score, where higher scores indicate greater child anxiety.
Immediately after cast application
Caregiver Anxiety Score
大体时间：Immediately after cast application
Caregivers will rate their own anxiety using a 0-100 score, where higher scores indicate greater caregiver anxiety.
Immediately after cast application
Caregiver-Rated Child Pain Before and After Cast Application
大体时间：Before and immediately after cast application
Caregivers will rate the child's pain before and after cast application using a 0-10 score, where higher scores indicate greater pain.
Before and immediately after cast application
Doctor-Related Fear at Follow-up
大体时间：1 day after cast application
Doctor-related fear after the cast experience will be assessed by a blinded child psychiatry clinician using a structured questionnaire. The assessment will include anxiety while returning to the hospital or doctor and reluctance to return to the doctor after the cast experience.
1 day after cast application
Post-Procedural Fear-Related Behaviors at Home
大体时间：From cast application to 1-day follow-up
Fear-related behaviors at home after cast application will be assessed by the blinded child psychiatry clinician using caregiver and child responses. These behaviors may include fear, crying, sleep disturbance, reluctance to visit the doctor, or other procedure-related distress.
From cast application to 1-day follow-up
Distress When Remembering the Cast Procedure
大体时间：1 day after cast application
The child's distress when remembering the cast application procedure will be assessed by the blinded child psychiatry clinician using a structured questionnaire item. Higher scores or more severe responses indicate greater procedure-related distress.
1 day after cast application
Caregiver Preference for Future Virtual Reality Use
大体时间：Immediately after cast application
Caregivers will be asked whether they would want virtual reality to be used again if a similar procedure is required. Responses will be recorded as yes, no, or undecided.
Immediately after cast application

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。

赞助

Başakşehir Çam & Sakura City Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2025年12月5日

初级完成 (估计的)

2026年8月30日

研究完成 (估计的)

2026年9月1日

研究注册日期

首次提交

2026年6月27日

首先提交符合 QC 标准的

2026年7月1日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年7月1日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2024KAEK11

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the results reported in the published article may be shared upon reasonable request. Shared data will not include names, national identification numbers, contact information, or any directly identifiable personal information. Because the study includes children and child psychiatry assessments, data sharing will be limited to anonymized research data and will require approval by the principal investigator and compliance with applicable ethics committee and institutional regulations.

IPD 共享时间框架

Data will become available beginning 6 months after publication of the main study results and will be available for 5 years.

IPD 共享访问标准

Data may be shared with qualified researchers who submit a scientifically sound research proposal. Requests will be reviewed by the principal investigator. Data will be shared only for approved research purposes and after completion of any required data use agreement and ethics or institutional approvals.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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