NCT07255365 Virtual Reality-Based 360° Clinic Walkthrough for Reducing Examination Anxiety in Preschool Children
| NCT ID | NCT07255365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Berker Okay |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2025-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-11-20 with a primary completion date of 2025-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07255365 clinical trial?
This trial is open to participants of all sexes, aged 36 Months or older, up to 66 Months, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07255365 currently recruiting?
Yes, NCT07255365 is actively recruiting participants. Contact the research team at drberkerokay@gmail.com for enrollment information.
Where is the NCT07255365 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07255365 clinical trial?
NCT07255365 is sponsored by Berker Okay. The trial plans to enroll 100 participants.
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