RecruitingNot ApplicableNCT07780331

The Effect of Using Virtual Reality Glasses and Gaming Cards on Fear, Anxiety, and Physiological Parameters in Children Administered Inhaler Medication

Sponsor

Bandırma Onyedi Eylül University

Enrollment

150 participants

Start Date

Sep 28, 2025

Study Type

INTERVENTIONAL

Conditions

Anxiety Respiratory Tract Diseases Fear Pediatric Disorders

Summary

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.

Eligibility

Min Age: 4 YearsMax Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Interactive Distraction Cards (DistrACTION® Cards), Standard Clinical Care, and others for people with anxiety, fear, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 4 Years to 6 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVirtual Reality Goggles (VR BOX)

Active cognitive distraction using a calibrated VR BOX headset equipped with 42mm aspheric optical resin lenses tailored to the child's interpupillary distance. Concurrently with standard medical nebulization, children watch an open-access 360-degree panoramic underwater world animation simulation video on a secure smartphone. The adjustable head strap allows concurrent mask placement. Duration matches the complete medical inhalation cycle (5-10 minutes), delivered in a single session. Clinical fear (CFS), state anxiety (CAS-S), and autonomically-driven physiology-specifically heart rate (HR), manual 60-second respiratory rate (RR), and oxygen saturation (SpO2)-are explicitly recorded at standardized pre-test (baseline) and post-test timelines immediately surrounding mask removal.

BEHAVIORALInteractive Distraction Cards (DistrACTION® Cards)

Interactive cognitive distraction using the patent-protected, liquid-impermeable laminated Pain Care Labs DistrACTION® Cards set held at the patient's exact eye level. Concurrently with standard emergency nebulization, the primary researcher verbally guides the child through structured, multi-layered visual illustrations and age-specific tasks (riddles, counting, find-and-search missions) printed on the reverse side to systematically capture working memory. Distraction lasts the entire inhalation cycle (5-10 minutes) in a single session. Clinical fear (CFS), state anxiety (CAS-S), and autonomically-driven physiology-specifically heart rate (HR), manual 60-second respiratory rate (RR), and oxygen saturation (SpO2)-are recorded at identical pre-test and post-test timelines.

OTHERStandard Clinical Care

Standard liquid aerosol emergency medical nebulization therapy administered by the unit clinical nursing staff according to routine hospital department guidelines and physician orders. The non-invasive mask delivery procedure is conducted entirely devoid of any supplementary non-pharmacological distraction materials, interactive cards, play-based therapies, or technological instruments, while maintaining regular parental presence at the bedside. To ensure comparative control, clinical fear (CFS), state anxiety (CAS-S), and physiological vital signs-specifically heart rate (HR), manual 60-second respiratory rate (RR), and oxygen saturation (SpO2)-are tracked at identical timelines.