Anxiety, Fear, Stress, Psychological
Conditions
Keywords
pediatric physical examination, examination anxiety, behavioral distress
Brief summary
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.
Interventions
BEHAVIORALirtual Reality 360° Clinic Walkthrough
A 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.
Sponsors
Berker Okay
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
Children were randomly assigned in a 1:1 ratio to either the virtual reality (VR) pre-examination group or the control group (routine waiting). Both groups underwent the same clinical examination by a blinded pediatrician.
Eligibility
Sex/Gender
ALL
Age
36 Months to 66 Months
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FLACC (Face-Legs-Activity-Cry-Consolability) behavioral distress score during examination | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Crying duration during examination | During the physical examination (same clinic visit). | Duration of crying (in seconds) recorded with a stopwatch during physical examination; shorter duration reflects lower procedural distress. |
| Parent satisfaction score | Immediately after the physical examination (same clinic visit). | Parent-rated satisfaction with the examination process, measured using a 5-point Likert scale (1 = very poor, 5 = excellent). |
Countries
Turkey (Türkiye)
Outcome results
None listed