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

NCT ID: NCT06986655

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-05-01

Brief Summary

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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

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Conditions

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Augmented Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Augmented Reality

Intervention Type 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.

Control Arm (Standard Care Group)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Augmented 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Koç University Hospital

UNKNOWN

Sponsor Role collaborator

Koç University

OTHER

Sponsor Role lead

Responsible Party

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Enes Simsek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Remziye Semerci Şahin, Assistant professor

Role: STUDY_DIRECTOR

Koç University

Locations

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Koç University Hospital

Istanbul, Zeytinburnu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023.206.IRB1.068

Identifier Type: -

Identifier Source: org_study_id

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