Does Virtual Reality Reduce Pain, Anxiety, Physiologic Stress, and Return-Visit Fear During Pediatric Forearm Casting? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Child Psychiatry-Assessed Cast Experience Anxiety Score at 1 Day
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Children, caregivers, and the orthopedic casting team cannot be blinded because the VR headset is visible during cast application. However, the child psychiatry clinician who performs the approximately 30-minute follow-up assessment 1 day after cast application will be blinded to group allocation. Children and caregivers will be instructed not to disclose whether virtual reality was used during the procedure.
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Child Psychiatry-Assessed Cast Experience Anxiety Score at 1 Day
时间窗: 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.
次要结局
- Procedural Anxiety Score During Cast Application(During cast application)
- Procedural Pain Score During Cast Application(During cast application)
- Change in Heart Rate During Cast Application(Before, during, and 2 minutes after cast application)
- Procedure Duration(During cast application)
- Physician-Rated Procedural Difficulty Score(During cast application)
- Child Behavioral Response During Cast Application(During cast application)
- Caregiver-Rated Child Anxiety(Immediately after cast application)
- Caregiver Anxiety Score(Immediately after cast application)
- Caregiver-Rated Child Pain Before and After Cast Application(Before and immediately after cast application)
- Doctor-Related Fear at Follow-up(1 day after cast application)
- Post-Procedural Fear-Related Behaviors at Home(From cast application to 1-day follow-up)
- Distress When Remembering the Cast Procedure(1 day after cast application)
- Caregiver Preference for Future Virtual Reality Use(Immediately after cast application)
研究者
Lezgin Mert
Principal Investigator
Başakşehir Çam & Sakura City Hospital