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

November 30, 2025 updated by: Berker Okay

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • SBÜ Sultangazi Haseki Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: irtual Reality (VR) Group

Children in this arm receive a 3-minute, 360° virtual reality (VR) pre-examination walkthrough of the actual pediatric outpatient clinic using a smartphone-based VR headset. The video presents the waiting area, greeting the pediatrician, and routine non-invasive examination steps from a child's eye-level perspective.

Intervention(s): Behavioral: Virtual Reality 360° Clinic Walkthrough
Behavioral: irtual 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.
No Intervention: Control Group

Children in this arm undergo standard pre-examination waiting without any VR or structured visual preparation. The waiting period is kept similar (approximately 3-5 minutes) to match the duration of the VR exposure.

Intervention(s): None (routine waiting only)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
During the physical examination (same clinic visit).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the physical examination (same clinic visit).
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).
Immediately after the physical examination (same clinic visit).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Berker Okay

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2025

Primary Completion (Estimated)

December 20, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Estimated)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 30, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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