AnxietyNCT07255365
Virtual Reality-Based 360° Clinic Walkthrough for Reducing Examination Anxiety in Preschool Children
A study testing irtual Reality 360° Clinic Walkthrough in people with Anxiety and Stress, Psychological, run by Berker Okay at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 66 monthsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Stress, Psychological, Fear
- What is being tested?
- irtual Reality 360° Clinic Walkthrough
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to 9 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 66 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Previous exposure to VR or 360° clinic simulations
- Concomitant sedative medication use
- Refusal of participation by parent or child
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBÜ Sultangazi Haseki Training and Research Hospital
Istanbul, Istanbul, 34010
About this study
Official title: 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.
- Conditions
- Anxiety, Stress, Psychological, Fear
- Being tested
- irtual Reality 360° Clinic Walkthrough
- Keywords
- pediatric physical examination, examination anxiety, behavioral distress
- Medical subject headings
- Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irtual Reality 360° Clinic WalkthroughBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the physical examination (same clinic visit).
Secondary outcomes (2)
Crying duration during examination
Duration of crying (in seconds) recorded with a stopwatch during physical examination; shorter duration reflects lower procedural distress.
Measured: During the physical examination (same clinic visit).
Parent satisfaction score
Parent-rated satisfaction with the examination process, measured using a 5-point Likert scale (1 = very poor, 5 = excellent).
Measured: Immediately after the physical examination (same clinic visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start20 Nov 2025
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berker Okay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Berker Okay, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255365
- Sponsor's protocol ID
- 248-2025
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 34374768PSA-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 36787767Baron-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 30885632Chen 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 35444779Zhang 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIRTUAL REALITY-BASED 360° CLINIC WALKTHROUGH: EFFECTS ON EXAMINATION ANXIETY AND PHYSICIAN EXAMINATION EASE IN CHILDREN
- ClinicalTrials.gov ID
- NCT07255365
- Acronym / sponsor ID
- 248-2025
- Conditions
- Anxiety, Stress, Psychological, Fear
- Keywords
- pediatric physical examination, examination anxiety, behavioral distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Berker OkayUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| irtual Reality (VR) Group | Experimental | Behavioral: irtual Reality 360° Clinic WalkthroughChildren 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 |
| 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) |
Who may qualify
- Ages
- 36 to 66 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| irtual Reality 360° Clinic WalkthroughA 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. | Behavioural | irtual Reality (VR) Group |
Primary outcome
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).
2 secondary outcomes
Crying duration during examination
Time frame: During the physical examination (same clinic visit).
Parent satisfaction score
Time frame: Immediately after the physical examination (same clinic visit).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 34374768Escalante 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.
- Background: PubMed 36787767PSA-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.
- Background: PubMed 30885632Baron-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.
- Background: PubMed 35444779Chen 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.
- Background: PubMed 31356268Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing irtual Reality 360° Clinic Walkthrough in people with Anxiety and Stress, Psychological, run by Berker Okay at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC (Face-Legs-Activity-Cry-Consolability) behavioral distress score during examination (time frame: During the physical examination (same clinic visit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07255365, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.