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

Condition(s) studied

Investigational drug(s) / intervention(s)

Virtual 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.

Interactive 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.

Standard 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.

Study 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

Primary outcome measure(s)

• State Anxiety Levels — Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
  Self-reported by the child using the Children's Anxiety Scale-State (CAS-S) visual thermometer instrument. The scores range from 0 (not anxious/nervous at all) to 10 (very highly anxious/nervous), where higher scores reflect elevated state anxiety linked to the medical procedure.
• Procedural Fear Levels — Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
  Evaluated using the Children's Fear Scale (CFS) through a triangulation method combining independent observations from the child, parent, and the researcher. The scale consists of 5 facial icons scored from 0 (no fear) to 4 (extreme fear), where higher scores indicate higher levels of procedural fear.

Trial sites (1)

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