PainNCT06993259
Effect of Virtual Reality and Serious Games on Pain, Fear, Anxiety, and Satisfaction During Skin Prick Testing in Children
A study testing Virtual Reality and Serious game in people with Pain and Anxiety, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the effectiveness of virtual reality (VR) and serious gaming (SG) in reducing pain, fear, and anxiety, and improving satisfaction during skin prick testing (SPT) in children aged 6-12 years. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- What is being tested?
- Virtual Reality and Serious game
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 15 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 to 12 years
- Scheduled to undergo an allergy skin prick test
- No visual impairments
- No use of anxiolytic or analgesic medication within the past six hours
- Voluntary agreement to participate (child assent and parental consent)
Who cannot join
- Not within the 6-12 age range
- Not scheduled for an allergy skin prick test
- Presence of visual impairments
- Use of anxiolytic or analgesic medication within the past six hours
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Virtual Reality and Serious Games on Pain, Fear, Anxiety, and Satisfaction During Skin Prick Testing in Children Aged 6-12 Years: A Randomized Controlled Trial
This randomized controlled trial evaluated the effectiveness of virtual reality (VR) and serious gaming (SG) in reducing pain, fear, and anxiety, and improving satisfaction during skin prick testing (SPT) in children aged 6-12 years. A total of 90 children were randomly assigned to three groups: standard care (control), VR, or SG. The VR group watched a 360° animated video using a headset, while the SG group played Subway Surfers on a tablet. Pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction (VAS) were measured post-procedure.
- Being tested
- Virtual Reality, Serious game
- Medical subject headings
- Pain, Anxiety Disorders, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Children in the virtual reality (VR) group watched a 360° Ice Age video via headset starting three minutes before and continuing throughout the allergy test. The video, selected by pediatric experts, was age-appropriate, visually rich, and emotionally neutral. VR provided immersive distraction to reduce pain, fear, and anxiety. After the test, children and parents rated pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction through structured forms.
Serious gameDevice
Children in the serious game group played Subway Surfers on a tablet starting three minutes before and continuing throughout the skin prick test. The game was chosen by pediatric experts for its age-appropriateness and ability to sustain attention without overstimulation. As a fast-paced, interactive tool, it served as an effective distraction to reduce pain, fear, and anxiety. After the procedure, children and parents rated pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction using structured feedback forms.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Serious Game | Experimental | Not described Receives: Device: Serious game |
| Virtual Reality | Experimental | Not described Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Facial Expression Rating Scale
The Wong-Baker FACES scale includes six facial expressions scored from 0 ("No Pain") to 10 ("Worst Pain"). Children select the face that best represents their pain. Valid for ages 3-18, it is widely used for its simplicity and strong psychometric properties and has been translated into many languages, including Turkish.
Measured: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
Child Fear Scale
The Child Fear Scale consists of six facial expressions scored from 0 (no fear) to 10 (highest fear) in increments of two. Fear increases progressively across the faces. Its validity and reliability were confirmed by Avşan et al. (2024), and it aligns with pain scales in format and scoring.
Measured: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
Child Anxiety State Scale
The Child Anxiety State Scale (CAS-S), developed by Ersig et al. (2013), was validated in Turkish by Özalp Gerçeker et al. (2019). Designed for children aged 4-10, it resembles a thermometer and measures current anxiety ("right now"). The scale has strong psychometric properties and is suitable for clinical use.
Measured: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
Secondary outcomes (1)
VAS Care Satisfaction Score
The Visual Analog Scale (VAS) for care satisfaction was used to evaluate children's satisfaction with the care received during the allergy testing procedure. Children were asked to indicate their level of satisfaction on a scale ranging from "0 - Not satisfied at all" to "10 - Very satisfied."
Measured: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Jan 2025
- Primary completion8 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research was designed as a randomized controlled trial with a parallel-group structure (intervention-control) to examine the effects of serious gaming and virtual reality interventions on reducing pain, fear, and anxiety levels, as well as improving care satisfaction among children aged 6-12 years who underwent skin prick tests.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remziye Semerci, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993259
- Sponsor's protocol ID
- KOC_UNI
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and the lack of participant consent for data sharing beyond the scope of this study.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Virtual Reality and Serious Games on Pain, Fear, Anxiety, and Satisfaction During Skin Prick Testing in Children Aged 6-12 Years: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06993259
- Acronym / sponsor ID
- KOC_UNI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 28 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.
This randomized controlled trial evaluated the effectiveness of virtual reality (VR) and serious gaming (SG) in reducing pain, fear, and anxiety, and improving satisfaction during skin prick testing (SPT) in children aged 6-12 years. A total of 90 children were randomly assigned to three groups: standard care (control), VR, or SG. The VR group watched a 360° animated video using a headset, while the SG group played Subway Surfers on a tablet. Pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction (VAS) were measured post-procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This research was designed as a randomized controlled trial with a parallel-group structure (intervention-control) to examine the effects of serious gaming and virtual reality interventions on reducing pain, fear, and anxiety levels, as well as improving care satisfaction among children aged 6-12 years who underwent skin prick tests.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Serious Game | Experimental | Device: Serious game |
| Virtual Reality | Experimental | Device: Virtual Reality |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6 to 12 years
- Scheduled to undergo an allergy skin prick test
- No visual impairments
- No use of anxiolytic or analgesic medication within the past six hours
- Voluntary agreement to participate (child assent and parental consent)
Key exclusion criteria (5 listed)
- Not within the 6-12 age range
- Not scheduled for an allergy skin prick test
- Presence of visual impairments
- Use of anxiolytic or analgesic medication within the past six hours
- Refusal to participate
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 |
|---|---|---|
| Virtual RealityChildren in the virtual reality (VR) group watched a 360° Ice Age video via headset starting three minutes before and continuing throughout the allergy test. The video, selected by pediatric experts, was age-appropriate, visually rich, and emotionally neutral. VR provided immersive distraction to reduce pain, fear, and anxiety. After the test, children and parents rated pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction through structured forms. | Device | Virtual Reality |
| Serious gameChildren in the serious game group played Subway Surfers on a tablet starting three minutes before and continuing throughout the skin prick test. The game was chosen by pediatric experts for its age-appropriateness and ability to sustain attention without overstimulation. As a fast-paced, interactive tool, it served as an effective distraction to reduce pain, fear, and anxiety. After the procedure, children and parents rated pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction using structured feedback forms. | Device | Serious Game |
Primary outcome
Wong-Baker Facial Expression Rating Scale
Time frame: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
The Wong-Baker FACES scale includes six facial expressions scored from 0 ("No Pain") to 10 ("Worst Pain"). Children select the face that best represents their pain. Valid for ages 3-18, it is widely used for its simplicity and strong psychometric properties and has been translated into many languages, including Turkish.
Child Fear Scale
Time frame: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
The Child Fear Scale consists of six facial expressions scored from 0 (no fear) to 10 (highest fear) in increments of two. Fear increases progressively across the faces. Its validity and reliability were confirmed by Avşan et al. (2024), and it aligns with pain scales in format and scoring.
Child Anxiety State Scale
Time frame: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
The Child Anxiety State Scale (CAS-S), developed by Ersig et al. (2013), was validated in Turkish by Özalp Gerçeker et al. (2019). Designed for children aged 4-10, it resembles a thermometer and measures current anxiety ("right now"). The scale has strong psychometric properties and is suitable for clinical use.
1 secondary outcome
VAS Care Satisfaction Score
Time frame: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
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 28 May 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and the lack of participant consent for data sharing beyond the scope of this study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Serious game in people with Pain and Anxiety, run by Trakya 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 28 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?
Wong-Baker Facial Expression Rating Scale (time frame: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)). 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 28 May 2025.