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OpenTrials
Completed

NCT Number: NCT07255365

Virtual Reality-Based 360° Clinic Walkthrough for Reducing Examination Anxiety in Preschool Children

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Fear Mental Disorders Stress, Psychological

Age range

36 month–66 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SBÜ Sultangazi Haseki Training and Research Hospital

Istanbul, 34010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

irtual Reality 360° Clinic Walkthrough

Behavioral

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.

Primary outcomes

  1. FLACC (Face-Legs-Activity-Cry-Consolability) behavioral distress score during examination

    Time frame: 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 outcomes

  1. Crying duration during examination

    Time frame: 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.

  2. Parent satisfaction score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Berker Okay

Other

Registry information

Official study title

VIRTUAL REALITY-BASED 360° CLINIC WALKTHROUGH: EFFECTS ON EXAMINATION ANXIETY AND PHYSICIAN EXAMINATION EASE IN CHILDREN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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