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CompletedNCT06986655Updated May 23, 2025

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

An interventional study of Augmented Reality in Augmented Reality, sponsored by Koç University. Completed at 1 site in Turkey. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Koç University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Aug 2023, registered May 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
4 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Augmented Reality

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Keywords

  • allergy
  • pediatric
  • augmented reality
  • pain
  • anxiety
  • care satisfaction
03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 66 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Koç University is the lead sponsor of 106 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 12 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Intervention Arm (AR Group)

    Children in this group will be exposed to 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.

    Other: Augmented Reality

  • No intervention
    Control Arm (Standard Care Group)

    Children in this group will undergo allergy testing following standard clinical procedures without any AR intervention or distraction.

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.

06

What researchers measure

Primary outcomes

  1. Pain Level

    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.

    Time frame: Immediately after the allergy testing procedure.

  2. Fear level

    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.

    Time frame: Immediately before and after the allergy testing procedure.

  3. Care Satisfaction

    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").

    Time frame: Immediately after the allergy testing procedure.

07

Study locations

1 site
  • Koç University Hospital
    Istanbul, Zeytinburnu 34010, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06986655
Lead sponsor
Koç University
Collaborators
Koç University Hospital
Responsible party
Enes Simsek (Principal Investigator, Koç University) — Principal investigator
First posted
May 23, 2025
Start date
Aug 1, 2023
Primary completion
May 1, 2025
Completion
May 1, 2025
Last update
May 23, 2025

Study contacts

Remziye Semerci Şahin, Assistant professor
study director · Koç University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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