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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Pain Level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 12 Years (Child)
- Sex
- 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
- •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.
Arms & Interventions
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.
Intervention: Augmented Reality (Other)
Control Arm (Standard Care Group)
Children in this group will undergo allergy testing following standard clinical procedures without any AR intervention or distraction.
Outcomes
Primary Outcomes
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.
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.
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").
Secondary Outcomes
No secondary outcomes reported
Investigators
Enes Simsek
Principal Investigator
Koç University