Virtual Reality-Based 360° Clinic Walkthrough for Reducing Examination Anxiety in Preschool Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age36-66
SponsorBerker Okay
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
irtual Reality 360° Clinic Walkthrough
BehavioralA brief, 3-minute 360° video recorded in the actual pediatric outpatient clinic, viewed via VR goggles before examination. The content is child-friendly, non-invasive, and designed to familiarize children with the clinical environment and examination steps to reduce anticipatory anxiety and distress.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: irtual Reality (VR) GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
FLACC (Face-Legs-Activity-Cry-Consolability) behavioral distress score during examination
Behavioral distress and pain level during physical examination, assessed using the FLACC scale (score range 0-10; higher scores indicate greater distress).
Time frame
During the physical examination (same clinic visit).Secondary outcomes
1
Crying duration during examination
Duration of crying (in seconds) recorded with a stopwatch during physical examination; shorter duration reflects lower procedural distress.
Time frame
During the physical examination (same clinic visit).2
Parent satisfaction score
Parent-rated satisfaction with the examination process, measured using a 5-point Likert scale (1 = very poor, 5 = excellent).
Time frame
Immediately after the physical examination (same clinic visit).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Berker Okay
Lead sponsor
Haseki Training and Research Hospital
Sponsor institution
Source ClinicalTrials.gov