VIRTUAL REALITY-BASED 360° CLINIC WALKTHROUGH: EFFECTS ON EXAMINATION ANXIETY AND PHYSICIAN EXAMINATION EASE IN CHILDREN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- FLACC (Face-Legs-Activity-Cry-Consolability) behavioral distress score during examination
研究概览
简要总结
This prospective, double-blind, randomized controlled trial investigates whether a short, 360° virtual reality (VR) pre-examination walkthrough can reduce anxiety, behavioral distress, and physiological stress responses in preschool children undergoing routine outpatient physical examination. A total of 100 children aged 3-5.5 years were randomized to either a VR group, which viewed a 3-minute real-clinic 360° video via VR goggles, or a control group, which experienced routine waiting only. Primary outcome measures include the Face-Legs-Activity-Cry-Consolability (FLACC) score and crying duration during examination. Secondary outcomes include heart and respiratory rate changes, Wong-Baker Faces Pain Rating Scale (WBS) scores, parent satisfaction, and physician-rated examination ease. The study aims to determine whether immersive, procedure-specific VR preparation can improve examination experience and cooperation while reducing stress for both children and caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Children and parents were unaware of the study hypothesis. The examining pediatrician and the observer scoring behavioral outcomes were blinded to group allocation. The data analyst also remained blinded until after data lock, ensuring double-blind assessment at evaluator and analyst levels.
入排标准
- 年龄范围
- 36 Months 至 66 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 3 to 5.5 years (36-66 months)
- •Clinically stable and presenting for routine outpatient physical examination
- •Able to engage with a short audiovisual VR/360° video
- •Written informed consent from a parent or legal guardian
- •Verbal assent from the child when appropriate
排除标准
- •Severe neurodevelopmental delay or communication difficulty
- •Autism spectrum disorder or significant behavioral dysregulation
- •History of epilepsy or photosensitivity
- •Visual or hearing impairment preventing VR use
- •Acute illness requiring urgent intervention
- •Body temperature ≥ 38.0°C at presentation
- •Previous exposure to VR or 360° clinic simulations
- •Concomitant sedative medication use
- •Refusal of participation by parent or child
研究组 & 干预措施
irtual Reality (VR) Group
Children in this arm receive a 3-minute, 360° virtual reality (VR) pre-examination walkthrough of the actual pediatric outpatient clinic using a smartphone-based VR headset. The video presents the waiting area, greeting the pediatrician, and routine non-invasive examination steps from a child's eye-level perspective.
Intervention(s): Behavioral: Virtual Reality 360° Clinic Walkthrough
干预措施: irtual Reality 360° Clinic Walkthrough (Behavioral)
Control Group
Children in this arm undergo standard pre-examination waiting without any VR or structured visual preparation. The waiting period is kept similar (approximately 3-5 minutes) to match the duration of the VR exposure.
Intervention(s): None (routine waiting only)
结局指标
主要结局
FLACC (Face-Legs-Activity-Cry-Consolability) behavioral distress score during examination
时间窗: During the physical examination (same clinic visit).
Behavioral distress and pain level during physical examination, assessed using the FLACC scale (score range 0-10; higher scores indicate greater distress).
次要结局
- Crying duration during examination(During the physical examination (same clinic visit).)
- Parent satisfaction score(Immediately after the physical examination (same clinic visit).)
研究者
Berker Okay
MD - Pediatrician (Principal Investigator)
Haseki Training and Research Hospital