Procedural PainNCT07796087
Three Distraction Techniques for Pain and Anxiety in Children During Allergy Skin Prick Testing
A study testing Animated cartoon distraction, Distraction card intervention and Interactive video game distraction in people with Procedural Pain and Procedural Anxiety, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial compared three distraction techniques-animated cartoons, DistrACTION® Cards, and interactive video games-with standard care for reducing procedural pain and anxiety in children aged 6-10 years undergoing allergy skin prick testing. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Procedural Pain, Procedural Anxiety
- What is being tested?
- Animated cartoon distraction, Distraction card intervention and Interactive video game distraction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2019to 21 Jan 2020
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 6-10 years
- Referred for allergy skin prick testing
- Consent of both child and parent
- No analgesic use in the previous six hours
- Able to understand the Wong-Baker FACES Pain Rating Scale and answer the card questions
Who cannot join
- Neurodevelopmental conditions (diagnosis of autism or intellectual disability)
- Chronic mental, cognitive, or visual problems
- Cognitive, visual, or hearing impairment preventing scale use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul
About this study
Official title: The Effect of Three Different Distraction Techniques on Anxiety and Pain Levels in Children During Allergy Skin Prick Testing: A Randomized Controlled Trial
This randomized controlled trial compared three distraction techniques-animated cartoons, DistrACTION® Cards, and interactive video games-with standard care for reducing procedural pain and anxiety in children aged 6-10 years undergoing allergy skin prick testing. A total of 161 children were randomly assigned to four groups. Pain was rated by the child, a parent, and the researcher with the Wong-Baker FACES Pain Rating Scale during and after the procedure, and anxiety was rated by the parent and the researcher with the Children's Fear Scale before, during, and after the procedure.
Read the detailed description
This single-center, four-arm, parallel-group randomized controlled trial was conducted in the pediatric allergy outpatient clinic of a training and research hospital in Istanbul, Turkey, between November 2019 and January 2020. Children aged 6-10 years referred for allergy skin prick testing were randomly allocated by computer-generated assignment to a cartoon group (n = 40), a DistrACTION® Cards group (n = 40), a video game group (n = 40), or a standard-care control group (n = 41). All tests were performed by the same pediatric nurse under identical conditions. Between-group differences were tested with one-way ANOVA and change over time with two-way repeated-measures ANOVA.
- Conditions
- Procedural Pain, Procedural Anxiety
- Being tested
- Animated cartoon distraction, Distraction card intervention, Interactive video game distraction
- Keywords
- child, distraction, skin prick test, video games, cartoons, distraction cards
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animated cartoon distractionBehavioural
Children watched a self-selected, age-appropriate animated cartoon on a tablet computer during the skin prick test.
Distraction card interventionBehavioural
Children viewed DistrACTION® Cards and answered goal-directed visual-search questions asked by the researcher during the skin prick test.
Interactive video game distractionBehavioural
Children played a self-selected interactive video game on a tablet with the non-tested arm during the skin prick test.
| Study group | Role | What they receive |
|---|---|---|
| Cartoon group (CG) | Experimental | Children watched a self-selected, age-appropriate animated cartoon on a tablet computer during the skin prick test. Receives: Behavioral: Animated cartoon distraction |
| DistrACTION® Cards group (DC) | Experimental | Children viewed DistrACTION® Cards and answered goal-directed visual-search questions asked by the researcher during the skin prick test. Receives: Behavioral: Distraction card intervention |
| Video game group (VG) | Experimental | Children played a self-selected interactive video game on a tablet with the non-tested arm during the skin prick test. Receives: Behavioral: Interactive video game distraction |
| Control group (C) | No intervention | Children received the clinic's standard protocol; the nurse explained and performed the test, and no additional distraction was provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child-reported procedural pain
Pain self-reported by the child on the Wong-Baker FACES Pain Rating Scale (0 = no pain to 10 = worst possible pain; higher scores indicate more pain).
Measured: During the skin prick test, a procedure lasting approximately 3 minutes
Secondary outcomes (6)
Child-reported pain after the procedure
Pain self-reported by the child on the Wong-Baker FACES Pain Rating Scale (0 = no pain to 10 = worst possible pain; higher scores indicate more pain).
Measured: Immediately after the skin prick test, up to 15 minutes after the procedure
Parent-reported pain
Pain reported by the parent on the Wong-Baker FACES Pain Rating Scale (0 = no pain to 10 = worst possible pain; higher scores indicate more pain).
Measured: During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)
Researcher-reported pain
Pain reported by the researcher on the Wong-Baker FACES Pain Rating Scale (0 = no pain to 10 = worst possible pain; higher scores indicate more pain).
Measured: During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)
Parent-reported anxiety
Anxiety reported by the parent using the Children's Fear Scale (0 = no anxiety to 4 = severe anxiety; higher scores indicate higher anxiety).
Measured: Approximately 10 minutes before the skin prick test, during the test (approximately 3 minutes), and immediately after the procedure (up to 15 minutes)
Researcher-reported anxiety
Anxiety reported by the researcher using the Children's Fear Scale (0 = no anxiety to 4 = severe anxiety; higher scores indicate higher anxiety).
Measured: Approximately 10 minutes before the skin prick test, during the test (approximately 3 minutes), and immediately after the procedure (up to 15 minutes)
Interrater agreement
Intraclass correlation coefficient between child, parent, and researcher ratings.
Measured: During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start7 Nov 2019
- Primary completion12 Jan 2020
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Responsible party
- Principal investigator, Leyla Erdim, Istanbul University
- Investigators
- Leyla Erdim, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796087
- Sponsor's protocol ID
- 2019-19-01
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Three Different Distraction Techniques on Anxiety and Pain Levels in Children During Allergy Skin Prick Testing: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07796087
- Acronym / sponsor ID
- 2019-19-01
- Conditions
- Procedural Pain, Procedural Anxiety
- Keywords
- child, distraction, skin prick test, video games, cartoons, distraction cards
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 12 Jan 2020 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 31 Aug 2026 (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 compared three distraction techniques-animated cartoons, DistrACTION® Cards, and interactive video games-with standard care for reducing procedural pain and anxiety in children aged 6-10 years undergoing allergy skin prick testing. A total of 161 children were randomly assigned to four groups. Pain was rated by the child, a parent, and the researcher with the Wong-Baker FACES Pain Rating Scale during and after the procedure, and anxiety was rated by the parent and the researcher with the Children's Fear Scale before, during, and after the procedure.
Detailed description
This single-center, four-arm, parallel-group randomized controlled trial was conducted in the pediatric allergy outpatient clinic of a training and research hospital in Istanbul, Turkey, between November 2019 and January 2020. Children aged 6-10 years referred for allergy skin prick testing were randomly allocated by computer-generated assignment to a cartoon group (n = 40), a DistrACTION® Cards group (n = 40), a video game group (n = 40), or a standard-care control group (n = 41). All tests were performed by the same pediatric nurse under identical conditions. Between-group differences were tested with one-way ANOVA and change over time with two-way repeated-measures ANOVA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cartoon group (CG) | Experimental | Behavioral: Animated cartoon distractionChildren watched a self-selected, age-appropriate animated cartoon on a tablet computer during the skin prick test. |
| DistrACTION® Cards group (DC) | Experimental | Behavioral: Distraction card interventionChildren viewed DistrACTION® Cards and answered goal-directed visual-search questions asked by the researcher during the skin prick test. |
| Video game group (VG) | Experimental | Behavioral: Interactive video game distractionChildren played a self-selected interactive video game on a tablet with the non-tested arm during the skin prick test. |
| Control group (C) | No intervention | –Children received the clinic's standard protocol; the nurse explained and performed the test, and no additional distraction was provided. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 6-10 years
- Referred for allergy skin prick testing
- Consent of both child and parent
- No analgesic use in the previous six hours
- Able to understand the Wong-Baker FACES Pain Rating Scale and answer the card questions
Key exclusion criteria (3 listed)
- Neurodevelopmental conditions (diagnosis of autism or intellectual disability)
- Chronic mental, cognitive, or visual problems
- Cognitive, visual, or hearing impairment preventing scale use
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 |
|---|---|---|
| Animated cartoon distractionChildren watched a self-selected, age-appropriate animated cartoon on a tablet computer during the skin prick test. | Behavioural | Cartoon group (CG) |
| Distraction card interventionChildren viewed DistrACTION® Cards and answered goal-directed visual-search questions asked by the researcher during the skin prick test. | Behavioural | DistrACTION® Cards group (DC) |
| Interactive video game distractionChildren played a self-selected interactive video game on a tablet with the non-tested arm during the skin prick test. | Behavioural | Video game group (VG) |
Primary outcome
Child-reported procedural pain
Time frame: During the skin prick test, a procedure lasting approximately 3 minutes
Pain self-reported by the child on the Wong-Baker FACES Pain Rating Scale (0 = no pain to 10 = worst possible pain; higher scores indicate more pain).
6 secondary outcomes
Child-reported pain after the procedure
Time frame: Immediately after the skin prick test, up to 15 minutes after the procedure
Parent-reported pain
Time frame: During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)
Researcher-reported pain
Time frame: During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)
Parent-reported anxiety
Time frame: Approximately 10 minutes before the skin prick test, during the test (approximately 3 minutes), and immediately after the procedure (up to 15 minutes)
Researcher-reported anxiety
Time frame: Approximately 10 minutes before the skin prick test, during the test (approximately 3 minutes), and immediately after the procedure (up to 15 minutes)
Interrater agreement
Time frame: During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)
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 31 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
Leyla Erdim principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animated cartoon distraction, Distraction card intervention and Interactive video game distraction in people with Procedural Pain and Procedural Anxiety, run by Istanbul 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 3 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 31 Aug 2026. 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?
Child-reported procedural pain (time frame: During the skin prick test, a procedure lasting approximately 3 minutes). 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 31 Aug 2026.