About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- irtual Reality 360° Clinic Walkthrough
Treatment groups
Sponsors and collaborators
Berker Okay
Lead sponsor
Haseki Training and Research Hospital
Sponsor institution