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CompletedNCT07255365Updated Jul 21, 2026

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

An interventional study of irtual Reality 360° Clinic Walkthrough in Anxiety, Stress, Psychological and Fear, sponsored by Berker Okay. Completed at 1 site in Turkey (Türkiye). Open to participants aged 36 Months to 66 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Berker Okay · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
36 Months to 66 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Anxiety
  • Stress, Psychological
  • Fear

Keywords

  • pediatric physical examination
  • examination anxiety
  • behavioral distress
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Berker Okay is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
36 Months to 66 Months
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • 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

  • 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)

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.

06

What researchers measure

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).

    Time frame: During the physical examination (same clinic visit).

Secondary outcomes

  1. Crying duration during examination

    Duration of crying (in seconds) recorded with a stopwatch during physical examination; shorter duration reflects lower procedural distress.

    Time frame: During the physical examination (same clinic visit).

  2. Parent satisfaction score

    Parent-rated satisfaction with the examination process, measured using a 5-point Likert scale (1 = very poor, 5 = excellent).

    Time frame: Immediately after the physical examination (same clinic visit).

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Study locations

1 site
  • SBÜ Sultangazi Haseki Training and Research Hospital
    Istanbul, Istanbul 34010, Turkey (Türkiye)
08

References and documents

Publications

  • Escalante A, Mendoza-Flores R, Gosset G, Bolivar F. The aminoshikimic acid pathway in bacteria as source of precursors for the synthesis of antibacterial and antiviral compounds. J Ind Microbiol Biotechnol. 2021 Dec 23;48(9-10):kuab053. doi: 10.1093/jimb/kuab053. PubMed 34374768 ↗
  • PSA-Screening in Schweden: Deutlich geringere Prostatakarzinom-Mortalitat. Aktuelle Urol. 2023 Feb;54(1):10. doi: 10.1055/a-1925-4156. Epub 2023 Feb 14. No abstract available. German. PubMed 36787767 ↗
  • Baron-Mendoza I, Del Moral-Sanchez I, Martinez-Marcial M, Garcia O, Garzon-Cortes D, Gonzalez-Arenas A. Dendritic complexity in prefrontal cortex and hippocampus of the autistic-like mice C58/J. Neurosci Lett. 2019 Jun 11;703:149-155. doi: 10.1016/j.neulet.2019.03.018. Epub 2019 Mar 15. PubMed 30885632 ↗
  • Chen B, Wang Z, Chen Z, Qu X, Fang X, Wang X, Ke G. Comparison of Two Surgical Approaches to Supination-External Rotation-Type Ankle Fractures. J Healthc Eng. 2022 Apr 11;2022:7726726. doi: 10.1155/2022/7726726. eCollection 2022. PubMed 35444779 ↗
  • 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. PubMed 31356268 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07255365
Lead sponsor
Berker Okay
Responsible party
Berker Okay (MD - Pediatrician (Principal Investigator), Haseki Training and Research Hospital) — Sponsor-investigator
First posted
Dec 1, 2025
Start date
Nov 20, 2025
Primary completion
Jan 9, 2026
Completion
Jan 9, 2026
Last update
Jul 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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