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

NCT06986655 | Completed

• 1 other identifier: 2023.206.IRB1.068
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Augmented Reality

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Immediately after the allergy testing procedure.

• 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.

  Immediately before and after the allergy testing procedure.

• 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").

  Immediately after the allergy testing procedure.

Study Arms (2)

Intervention Arm (AR Group)

EXPERIMENTAL

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

Control Arm (Standard Care Group)

NO INTERVENTION

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

Interventions

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.

Intervention Arm (AR Group)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koç University: lead
• Koç University Hospital: collaborator

Study Sites (1)

Koç University Hospital

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypersensitivity; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Remziye Semerci Şahin, Assistant professor

  Koç University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: August 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)