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

Not Applicable

Completed

• Conditions: Augmented Reality

• Registration Number: NCT06986655
• Lead Sponsor: Koç University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Status Verified: 2025-05
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Level	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.
Fear level	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.
Care Satisfaction	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").

Trial Locations

Locations (1)

Koç University Hospital; 🇹🇷 Istanbul, Zeytinburnu, Turkey