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NCT Number: NCT06986655

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

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.

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Key information

Conditions

Augmented Reality Anxiety Disorders Hypersensitivity Immune System Diseases Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koç University Hospital

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Augmented Reality

Other

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.

Primary outcomes

  1. Pain Level

    Time frame: Immediately 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.

  2. Fear level

    Time frame: Immediately 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.

  3. Care Satisfaction

    Time frame: Immediately 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").

Sponsors and collaborators

Lead sponsor

Koç University

Other

Collaborators

  • Koc University Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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