The Effect of Using Virtual Reality Glasses and Gaming Cards on Fear, Anxiety, and Physiological Parameters in Children Administered Inhaler Medication
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2025
CompletedFirst Submitted
Initial submission to the registry
August 19, 2026
CompletedFirst Posted
Study publicly available on registry
August 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
August 21, 2026
August 1, 2026
1 year
August 19, 2026
August 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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]
Secondary Outcomes (3)
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]
Study Arms (3)
Virtual Reality Group
EXPERIMENTALIn 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
EXPERIMENTALIn 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
OTHERIn 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Susurluk State Hospital, Emergency Department
Balıkesir, Balıkesir, 10600, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 25030489BACKGROUNDDurak 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.
PMID: 33742204BACKGROUNDEijlers 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.
PMID: 31136330BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Diler Yılmaz, Prof. Dr.
Bandırma Onyedi Eylül University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- In addition to the blinding of the biostatistician during the data analysis phase, strict allocation concealment is maintained until the dynamic initiation of the intervention. The gender-stratified block randomization sequences, which were generated by an independent faculty member, remain entirely concealed from the primary researcher during the initial baseline pre-test evaluations and data collection process. The specific group assignment for each pediatric participant is revealed to the investigator only immediately prior to the implementation of the nebulizer treatment.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Graduate Student / Master's Candidate, Department of Pediatric Nursing
Study Record Dates
First Submitted
August 19, 2026
First Posted
August 21, 2026
Study Start
September 28, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
August 21, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
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.