Augmented RealityNCT06986655
The Effect of an Augmented Reality Game on Pain, Fear, and Care Satisfaction Levels During Allergy Testing in Children Aged 4-12 Years
A study testing Augmented Reality in people with Augmented Reality, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Augmented Reality
- What is being tested?
- Augmented Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koç University Hospital
Istanbul, Zeytinburnu, 34010
About this study
Official 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
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
- Being tested
- Augmented Reality
- Keywords
- allergy, pediatric, augmented reality, pain, anxiety, care satisfaction
- Medical subject headings
- Hypersensitivity, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented RealityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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").
Measured: Immediately after the allergy testing procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Aug 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Augmented RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Koc University Hospital
- Responsible party
- Principal investigator, Enes Simsek, Koç University
- Investigators
- Remziye Semerci Şahin, Assistant professor, Study director, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986655
- Sponsor's protocol ID
- 2023.206.IRB1.068
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06986655
- Acronym / sponsor ID
- 2023.206.IRB1.068
- Conditions
- Augmented Reality
- Keywords
- allergy, pediatric, augmented reality, pain, anxiety, care satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Koc University Hospital
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (AR Group) | Experimental | Other: Augmented RealityChildren 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. |
| 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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented RealityIn 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. | Other | Intervention Arm (AR Group) |
Primary outcome
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").
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
Related trials for Augmented Reality
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Active, not recruiting
EyeBreathe: A Mixed Reality Game With Eye Tracking and Breathing Biofeedback for Adolescent Basketball Players
Healthy Adolescents
Not yet recruiting
Using Virtual Reality to Augment Brief Interventions for Heavy Drinking Young Adults
Alcohol Misuse
Recruiting
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
Parkinson Disease, Freezing of Gait
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Remziye Semerci Şahin, Assistant professor study director
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality in people with Augmented Reality, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: Immediately after the allergy testing procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.