Actively Recruiting

Phase Not Applicable
Age: 36Months - 66Months
All Genders
Healthy Volunteers
NCT07255365

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

Led by Berker Okay · Updated on 2025-12-05

100

Participants Needed

1

Research Sites

5 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 36Months - 66Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 5.5 years (36-66 months)
  • Clinically stable and attending routine outpatient physical exams
  • Able to engage with a short audiovisual VR/360° video
  • Written informed consent from parent or guardian
  • Verbal assent from child when appropriate
Not Eligible

You will not qualify if you...

  • 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
  • Use of sedative medication
  • Refusal of participation by parent or child

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

SBÜ Sultangazi Haseki Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye), 34010

Actively Recruiting

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Research Team

B

Berker Okay

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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