NCT07780331|Recruiting
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Sponsor study identifier
interventional
150
1 country
1
Study Start
September 28, 2025
Actual (reported)Primary Completion
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 28, 2025
Actual (reported)August 19, 2026
Actual (reported)August 21, 2026
Actual (reported)October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
State Anxiety Levels
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.
Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
Procedural Fear Levels
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.
Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
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).
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.
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.
Susurluk State Hospital, Emergency Department
Balıkesir, Balıkesir, 10600, Turkey (Türkiye)
Canbulat N, Inal S, Sonmezer H. Efficacy of distraction methods on procedural pain and anxiety by applying distraction cards and kaleidoscope in children. Asian Nurs Res (Korean Soc Nurs Sci). 2014 Mar;8(1):23-8. doi: 10.1016/j.anr.2013.12.001. Epub 2013 Dec 14.
Durak H, Uysal G. The Effect of Cartoon Watching and Distraction Card on Physiologic Parameters and Fear Levels During Inhalation Therapy in Children: A Randomized Controlled Study. J Trop Pediatr. 2021 Jan 29;67(1):fmab018. doi: 10.1093/tropej/fmab018.
Diler Yılmaz, Prof. Dr.
Bandırma Onyedi Eylül University
First Submitted
August 19, 2026
The Effect Of Distraction Methods On Fear And Anxiety In Children Before The Covid 19 Test
Heart Rate
Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
Peripheral Oxygen Saturation (SpO2)
Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
Respiratory Rate
Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
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).
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 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.
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Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
First Posted
August 21, 2026
Study Start
September 28, 2025
Actual (reported)Primary Completion
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 21, 2026
Record last verified: 2026-08
Individual participant data will not be shared with external researchers in order to protect patient privacy and comply with national institutional ethical committee protocols regarding pediatric participant confidentiality.
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Source: ClinicalTrials.gov.
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