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The Effect of an Augmented Reality Game on Pain, Fear, and Care Satisfaction Levels During Allergy Testing in Children Aged 4-12 Years

The Effect of an Augmented Reality Game on Pain, Fear, and Care Satisfaction Levels During Allergy Testing in Children Aged 4-12 Years: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06986655
Enrollment
66
Registered
2025-05-23
Start date
2023-08-01
Completion date
2025-05-01
Last updated
2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Augmented Reality

Keywords

allergy, pediatric, augmented reality, pain, anxiety, care satisfaction

Brief summary

The aim of this study is to examine the effects of augmented reality (AR) games on pain, fear, and care satisfaction, and to contribute to the literature on innovative interventions that enhance the healthcare experiences of children undergoing allergy testing. H1: The pain level of children undergoing allergy testing in the AR group is lower than that of children in the control group. H2: The fear level of children undergoing allergy testing in the AR group is lower than that of children in the control group. H3: The care satisfaction level of children undergoing allergy testing in the AR group is higher than that of children in the control group.

Interventions

OTHERAugmented Reality

In this intervention children will play an augmented reality game during the allergy testing procedure. The game will be used as a distraction method to potentially reduce pain and fear, and enhance care satisfaction.

Sponsors

Koç University Hospital
CollaboratorUNKNOWN
Koç University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* Aged between 4 and 12 years. * Scheduled to undergo an allergy test. * No visual impairments that would interfere with the use of augmented reality -applications. * No use of anxiolytic or analgesic medications within the last six hours. * Willing to participate in the study, with parental/legal guardian consent as applicable.

Exclusion criteria

* Younger than 4 years or older than 12 years. * Not scheduled for an allergy test. * Presence of visual impairments. * Use of anxiolytic or analgesic medications within the last six hours. * Unwilling to participate in the study or lacking informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Pain LevelImmediately after the allergy testing procedure.Wong-Baker FACES Pain Rating Scale is used for this measurement. This scale consists of six facial expressions that represent increasing levels of pain, ranging from No pain (0 points) to Worst pain (10 points). Children are asked to point to the face that best matches the pain they are experiencing.
Fear levelImmediately before and after the allergy testing procedure.Children's Fear Scale is used for the fear measurement. This self-report tool consists of six facial expressions corresponding to fear levels, rated from 0 (no fear) to 10 (maximum fear), in increments of two points. Children are asked to select the face that best represents their emotional state.
Care SatisfactionImmediately after the allergy testing procedure.Visual Analog Scale (VAS) for Care Satisfaction is used to assess the child's satisfaction with the care received during the allergy test. The score ranges from 0 (Not satisfied at all) to 10 (Completely satisfied).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026