Description

This single-blind, parallel-group, randomized controlled clinical trial is designed to evaluate and compare the efficacy of two distinct cognitive distraction techniques, namely virtual reality goggles and interactive distraction cards, against a standard care control group on fear, anxiety, and vital physiological parameters in pediatric patients aged four to six years requiring inhaler medication within an emergency department setting. The study is actively being conducted at the Emergency Department of Susurluk State Hospital, having commenced in September 2025. The target sample size was rigorously calculated using G\*Power software based on a standard effect size of 0.25, a significance level of 0.05, and a statistical power of 0.90 for a mixed-design repeated measures analysis of variance, determining a minimum required sample size of 45 participants per group. To account for potential data loss or attrition during the ongoing clinical process, the sample size was increased by approximately ten percent, aiming to recruit a total of 150 pediatric patients equally distributed with 50 participants in each of the three study arms.

To eliminate selection bias and ensure an equal distribution of demographic factors, a stratified block randomization method based on gender is utilized. An online randomizer program is managed by an independent faculty member not involved in the research team to generate two separate randomization sequences for female and male children with variable block sizes of three and six to ensure balanced allocations across the arms. Sequential protocol numbers corresponding to the gender-specific lists are kept completely concealed from the primary researcher until immediately prior to the clinical intervention. While researcher blinding is impossible due to the nature of administering the interventions, a strict single-blind protocol is maintained for data analysis where the biostatistician will be provided a masked dataset labeling the cohorts as Group 1, Group 2, and Group 3 without knowing their true clinical identities.

The clinical protocol follows a precise chronological order across all groups within standardized, visually isolated monitoring bays in the observation unit to minimize external noise and patient-to-patient cross-contamination. First, parents are thoroughly briefed on the trial framework, written informed voluntary consent is obtained, and the introductory information form is completed. Second, children undergo a brief cognitive triage assessing basic counting skills up to ten and size relations to ensure developmental compliance with the testing instruments, and patients in the active arms are given two to three minutes to physically touch and acclimate to the intervention devices to diminish initial novelty anxiety while the control group receives standard nebulizer mask orientation only. Third, baseline physiological parameters including heart rate and oxygen saturation are continuously recorded using a calibrated pediatric vital monitor equipped with a soft finger probe, respiratory rates are assessed manually via visual observation for a full 60 seconds, pre-procedure state anxiety is self-reported by the child using the state anxiety scale thermometer tool, and baseline procedural fear is measured utilizing a strict multi-evaluator triangulation method where the child, the accompanying parent, and the researcher independent of each other fill out the fear scale.

During the intra-procedural interventions, simultaneously with the emergency nurse initiating the standard nebulization therapy, the first intervention group utilizes an immersive, age-appropriate 360-degree panoramic underwater animation video launched via a smartphone inside the VR BOX headset with an adjustable head strap that accommodates the concurrent placement of the respiratory mask, allowing the child to actively navigate the digital marine environment via head movements. Simultaneously with the nebulization in the second intervention group, the researcher presents the patented laminated distraction cards set at the child's eye level, verbally engaging the child with structured, age-specific interactive riddles and visual search tasks printed on the back of the cards to ensure active cognitive load recruitment and prevent passive looking. The control group receives standard medical nebulization therapy administered by the clinical staff per emergency department routines without any external distraction tools or technological interventions. Immediately following the completion of the nebulization and mask removal, post-test evaluations are executed across all cohorts where vital signs are re-recorded, post-procedure state anxiety is self-scored by the child, and procedural fear is independently re-evaluated by the child, parent, and researcher, followed by the systematic sanitation of all non-disposable materials with medical-grade alcohol wipes between participants.