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

NCT07255365 | Recruiting

• 1 other identifier: 248-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Stress, Psychological; Fear

Keywords

pediatric physical examination; examination anxiety; behavioral distress

Outcome Measures

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).

  During the physical examination (same clinic visit).

Secondary Outcomes (2)

• Crying duration during examination

  During the physical examination (same clinic visit).

• Parent satisfaction score

  Immediately after the physical examination (same clinic visit).

Study Arms (2)

irtual Reality (VR) Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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)

Interventions

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.

irtual Reality (VR) Group

Eligibility Criteria

• Age: 36 Months - 66 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Berker Okay: lead

Study Sites (1)

SBÜ Sultangazi Haseki Training and Research Hospital

Istanbul, Istanbul, 34010, Turkey (Türkiye)

RECRUITING

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• Zhang DDQ, Sussman J, Dossa F, Jivraj N, Ladha K, Brar S, Urbach D, Tricco AC, Wijeysundera DN, Clarke HA, Baxter NN. A Systematic Review of Behavioral Interventions to Decrease Opioid Prescribing After Surgery. Ann Surg. 2020 Feb;271(2):266-278. doi: 10.1097/SLA.0000000000003483.

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MeSH Terms

Conditions

Anxiety Disorders; Stress, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Berker Okay

CONTACT

+905385860550; drberkerokay@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD - Pediatrician (Principal Investigator)

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: November 20, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 31, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)