The Effect of Using Virtual Reality Glasses and Gaming Cards on Fear, Anxiety, and Physiological Parameters in Children Administered Inhaler Medication
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ecem Bakış, BSc, RN
- Phone Number: +90 5459355068
- Email: bakisecem0@gmail.com
Study Contact Backup
- Name: Diler Yılmaz, Prof. Dr.
- Email: daydin@bandirma.edu.tr
Study Locations
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Balıkesir
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Balıkesir, Balıkesir, Turkey (Türkiye), 10600
- Recruiting
- Susurluk State Hospital, Emergency Department
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Contact:
- Diler Yılmaz, Prof. Dr.
- Email: daydin@bandirma.edu.tr
-
Contact:
- Ecem Bakış, BSc, RN
- Phone Number: +90 545 935 50 68
- Email: bakisecem0@gmail.com
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Virtual Reality Group
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).
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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.
Other Names:
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Experimental: Distraction Cards Group
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.
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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.
Other Names:
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Other: Control Group
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).
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety Levels
Time Frame: Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
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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.
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Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
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Procedural Fear Levels
Time Frame: Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
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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.
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Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate
Time Frame: Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
|
Measured continuously using a calibrated Biolight V9 pediatric vital signs monitor with a soft finger probe to track autonomically-driven physiological stress responses.
Recorded in beats per minute (bpm).
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Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
|
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Peripheral Oxygen Saturation (SpO2)
Time Frame: Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
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Measured using a calibrated Biolight V9 pediatric vital signs monitor pulse oximetry probe to track respiratory ventilation quality and oxygenation tracking.
Recorded as a percentage (%).
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Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
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Respiratory Rate
Time Frame: Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
|
Assessed manually via direct visual observation of chest and abdominal wall excursions by the primary researcher using a stopwatch for a full 60 seconds to evaluate stabilization of the breathing pattern.
Recorded as breaths per minute.
|
Baseline (pre-procedure) and immediately after the final mask removal (post-procedure) [approximately 5-10 minutes apart]
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Diler Yılmaz, Prof. Dr., Bandırma Onyedi Eylül University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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