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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Virtual Tour of the Operating Theater on Fear and Anxiety of Preoperative Children

NCT05401539

Preoperative Anxiety

UNKNOWN NA

Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations

NCT04755998

Anxiety and Fear

COMPLETED NA

VR for Preoperative Anxiety in Children

NCT03201640

Anxiety

COMPLETED NA

The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children

NCT04824690

Anxiety Pain Satisfaction

COMPLETED NA

How Digital Media Affects Kids' Healthcare Experiences and Outcomes

NCT07073027

Children Adolescent Anxiety +4 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Stress, Psychological Fear

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

irtual Reality 360° Clinic Walkthrough

Intervention Type 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.

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

irtual 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

36 Months

Maximum Eligible Age

66 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes