| Registry | NCT07780331 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 150 (Estimated) |
| Sponsor | Bandırma Onyedi Eylül University (Other) |
| Conditions | Respiratory Tract Diseases, Pediatric Disorders, Anxiety, Fear |
| Interventions | Virtual Reality Goggles (VR BOX), Interactive Distraction Cards (DistrACTION® Cards), Standard Clinical Care (Device, behavioral, other) |
| Dates | start 2025-09-28, primary completion 2026-10-01 (estimated), completion 2026-10-01 (estimated), first posted 2026-08-21, last updated 2026-08-21 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Respiratory Tract Diseases All trials for Pediatric Disorders All trials of Virtual Reality Goggles (VR BOX) All trials of Interactive Distraction Cards (DistrACTION® Cards)
This study aims to evaluate the effects of using virtual reality headsets and play cards during the administration of inhaler medication in pediatric patients. The primary goal is to determine how these distraction methods influence children's fear, anxiety levels, and physiological parameters (such as heart rate and oxygen saturation). The study population consists of pediatric patients aged between 4 and 6 years. Data collection for the targeted sample size of 150 children commenced in September, and the recruitment process is currently ongoing.Children receiving inhaler treatments often experience fear and anxiety, which can negatively affect their treatment compliance and vital signs. In this study, participants are divided into different groups to compare the effectiveness of virtual reality headsets and traditional play cards as distraction tools.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual Reality Goggles (VR BOX) | In the virtual reality application, the researcher introduced the VR BOX goggles to the children before starting the inhaler therapy and allowed a 2 to 3-minute familiarization window. Concurrently with the initiation of the standard nebulization process, an age-appropriate 360-degree panoramic underwater world animation video was started inside the headset. This active distraction phase lasted for the entire duration of the inhalation therapy (approximately 5 to 10 minutes). The child actively explored the digital marine environment via head movements while breathing smoothly. The Children's Fear Scale (CFS), the Children's Anxiety Scale-State (CAS-S), and vital physiological parameters-specifically heart rate (HR), respiratory rate (RR), and peripheral oxygen saturation (SpO2)-were continuously monitored, evaluated, and recorded immediately before starting the therapy (baseline pre-test) and immediately after the final mask removal (post-test). |
| Distraction Cards Group | Experimental | Behavioral: Interactive Distraction Cards (DistrACTION® Cards) | In the distraction cards group, the researcher introduced the laminated interactive Pain Care Labs DistrACTION® Cards to the children before inhaler therapy. At the start of nebulization, the cards were presented at the child's eye level and used throughout the 5-10-minute inhalation period. The researcher maintained the child's attention through age-appropriate riddles, character identification, and search-and-find activities on the cards. The Children's Fear Scale (CFS), Children's Anxiety Scale-State (CAS-S), and physiological parameters, including heart rate (HR), respiratory rate (RR), and peripheral oxygen saturation (SpO₂), were assessed immediately before therapy and after mask removal. |
| Control Group | Other | Other: Standard Clinical Care | In the control group, pediatric patients received the physician-prescribed standard emergency nebulization therapy administered by the unit clinical staff according to routine hospital protocols, entirely devoid of any supplementary non-pharmacological distraction materials, technology, interactive play cards, or games during the therapy. Children underwent the inhalation procedure accompanied by their parents. The Children's Fear Scale (CFS), the Children's Anxiety Scale-State (CAS-S), and vital physiological parameters-specifically heart rate (HR), respiratory rate (RR), and peripheral oxygen saturation (SpO2)-were evaluated, measured, and recorded at identical timelines, immediately before starting the therapy (baseline pre-test) and immediately after the final mask removal (post-test). |
Sex: All, ages: 4 Years to 6 Years, accepts healthy volunteers
Inclusion Criteria: * Child being between the ages of 4 and 6 years. * Parents and children being completely voluntary to participate in the study. * Child having no visual, auditory, or cognitive communication barriers. * Child's cognitive level and motor development being appropriate for their age. * Child having no life-threatening acute or chronic systemic disease. * Child having no mental or neurological disability or condition. * Child and parent being fully open to effective communication and clinical cooperation. * Child having no medical condition that prevents inhaler mask or nebulizer application. Exclusion Criteria: * Child having any acute clinical condition that mechanically prevents inhaler treatment. * Child having a severe, life-threatening acute or chronic health problem at presentation. * Sudden development of severe clinical instability preventing completion of the trial.
| Facility | City | Country | Status |
|---|---|---|---|
| Susurluk State Hospital, Emergency Department | Balıkesir, Balıkesir | Turkey (Türkiye) | Recruiting |