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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Crying duration during examination | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Berker Okay | Contact | +905385860550 | drberkerokay@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SBÜ Sultangazi Haseki Training and Research Hospital | Recruiting | Istanbul | Istanbul | 34010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34374768 | Background | 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. | |
| 36787767 | Background | 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. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.
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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.
|
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). |
| 30885632 | Background | 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. |
| 35444779 | Background | 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. |
| 31356268 | Background | 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. |