AnxietyNCT07453615
Effect of AI(Artificial Intelligence)-Based Storytelling Video on Anxiety and Fear During Skin Prick Test in Children
A study testing AI-Generated Storytelling Video and Standard Clinic Care in people with Anxiety and Fear Anxiety, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effectiveness of an AI-generated therapeutic storytelling video on pre-procedural anxiety and fear levels in children aged 4 to 10 years undergoing their first Skin Prick Test (SPT). Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Anxiety, Fear Anxiety, Allergic Rhinitis
- What is being tested?
- AI-Generated Storytelling Video and Standard Clinic Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 9 Jul 2026
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 4 and 10 years (from 4th birthday to 11th birthday).
- Children undergoing a Skin Prick Test (SPT) for the first time.
- Presence of suspected Allergic Rhinitis and/or Asthma.
- Cognitive ability to understand Turkish, follow the video story, and interpret visual assessment scales.
- Parents with internet access to view the digital content.
- Obtained parental informed consent and child assent (for ages 7 and above)
Who cannot join
- Previous experience with Skin Prick Testing or a history of frequent medical procedures (e.g., frequent blood draws, surgeries) due to chronic illness.
- Diagnosed with Autism Spectrum Disorder, severe ADHD(attention deficit hyperactivity disorder), intellectual disability, or severe psychiatric conditions preventing cooperation.
- Significant visual or hearing impairments that prevent engagement with the video content.
- Use of anxiolytics, sedatives, or medications affecting cognitive functions within the last 24 hours.
- Chronic health problems (e.g., malignancy, immunodeficiency) that may elevate baseline anxiety levels.
- Patients undergoing SPT for suspected Food Allergy, Drug Allergy, or Bee Venom Allergy.
- For the intervention group: Failure to watch the video or answering the three "validation questions" incorrectly on the procedure day.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Antalya Training and Research Hospital
Antalya, 07030
About this study
Official title: AI-Based Video-Mediated Cognitive Preparation in Skin Prick Testing: A Prospective, Randomized Controlled Trial
This study evaluates the effectiveness of an AI-generated therapeutic storytelling video on pre-procedural anxiety and fear levels in children aged 4 to 10 years undergoing their first Skin Prick Test (SPT). The study aims to determine if watching a cognitive preparation video at home prior to the appointment reduces anxiety compared to standard care. Participants will be randomized into two groups: an intervention group watching the AI-generated video and a control group receiving standard clinic care
Read the detailed description
Skin Prick Testing (SPT) is a common diagnostic procedure in pediatric allergy clinics that often induces significant pre-procedural anxiety and acute needle fear in children. While digital distraction tools are becoming common during procedures, pre-procedural cognitive preparation strategies are limited. This randomized controlled trial investigates the impact of cognitive preparation using an AI-assisted therapeutic storytelling video.
+4
The study utilizes a prospective, single-blind, randomized controlled design. A total of 100 children (aged 4-10) with suspected respiratory allergies undergoing their first SPT will be randomized (1:1 ratio) into intervention and control groups.
- 3
- Intervention Group: Children will watch an AI-generated therapeutic storytelling video at home (the evening the appointment is made and the night before the procedure). The video, featuring characters "Ilay and Doctor Ipek", is designed to cognitively prepare the child for the procedure using age-appropriate metaphors without traumatizing elements.
- Control Group: Children will receive the clinic's standard routine care and verbal information.
- 4
Baseline anxiety is assessed using the Spence Preschool Anxiety Scale or Spence Children's Anxiety Scale. Procedural fear and pain are evaluated using the Children's Fear Scale (CFS) and the Wong-Baker FACES Scale. Behavioral responses during the procedure are observed and scored by a blinded nurse using the Children's Emotional Manifestation Scale (CEMS). The primary hypothesis is that AI-based cognitive preparation will significantly reduce pre-procedural anxiety and fear, and improve procedural compliance compared to standard care
- Conditions
- Anxiety, Fear Anxiety, Allergic Rhinitis, Asthma (Diagnosis)
- Being tested
- AI-Generated Storytelling Video, Standard Clinic Care
- Keywords
- Skin Prick Test, Artificial Intelligence, Cognitive Preparation, Storytelling
- Medical subject headings
- Anxiety Disorders, Rhinitis, Allergic, Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Generated Storytelling VideoBehavioural
A customized, AI-assisted animated story video featuring child-friendly characters (Lilly and Doctor Sunny) explaining the Skin Prick Test procedure. It is watched at home the evening the appointment is made and the night before the procedure to provide cognitive preparation.
Standard Clinic CareOther
Routine verbal explanation of the procedure provided by the clinic staff.
| Study group | Role | What they receive |
|---|---|---|
| AI-Video Intervention Group | Experimental | Participants in this group will watch an AI-generated therapeutic storytelling video about the Skin Prick Test procedure at home, twice before their clinical appointment Receives: Behavioral: AI-Generated Storytelling Video |
| Standard Care Group | Active comparator | Participants in this group will receive standard routine verbal information and standard clinic care prior to the procedure, without any digital preparatory intervention. Receives: Other: Standard Clinic Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Anxiety Level
Assessed using the Spence Preschool Anxiety Scale (for ages 4-6) or Spence Children's Anxiety Scale (for ages 7-10). These validated scales measure general anxiety symptoms. Higher scores indicate higher levels of anxiety.
Measured: Baseline
Acute Procedural Fear Level
Assessed using the Children's Fear Scale (CFS). This scale consists of five facial expressions representing a range from neutral (0) to extreme fear (4). Higher scores indicate higher levels of acute fear.
Measured: Immediately post-procedure
Secondary outcomes (2)
Behavioral Distress During Procedure
Assessed by a linded observer physician using the Children's Emotional Manifestation Scale (CEMS). It evaluates facial expression, vocalization, activity, interaction, and level of cooperation. Total scores range from 5 to 25, with higher scores indicating more negative emotional behaviors and higher distress
Measured: Periprocedural
Self-Reported Procedural Pain
Assessed using the Wong-Baker FACES Pain Rating Scale. The scale consists of six faces representing pain intensity, scored from 0 to 10. Higher scores indicate greater pain
Measured: within the first 5 minutes of the 15-minute SPT reading period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start15 Mar 2026
- Primary completion9 Jul 2026
- Study completion9 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453615
- Sponsor's protocol ID
- 2026-36
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in the future published article will be shared. This includes demographic characteristics, anxiety scale scores, fear scale scores, behavioral distress scores, and pain scores, strictly after removing any personally identifiable information
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Based Video-Mediated Cognitive Preparation in Skin Prick Testing: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07453615
- Acronym / sponsor ID
- 2026-36
- Conditions
- Anxiety, Fear Anxiety, Allergic Rhinitis, Asthma (Diagnosis)
- Keywords
- Skin Prick Test, Artificial Intelligence, Cognitive Preparation, Storytelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 6 Mar 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 study evaluates the effectiveness of an AI-generated therapeutic storytelling video on pre-procedural anxiety and fear levels in children aged 4 to 10 years undergoing their first Skin Prick Test (SPT). The study aims to determine if watching a cognitive preparation video at home prior to the appointment reduces anxiety compared to standard care. Participants will be randomized into two groups: an intervention group watching the AI-generated video and a control group receiving standard clinic care
Detailed description
Skin Prick Testing (SPT) is a common diagnostic procedure in pediatric allergy clinics that often induces significant pre-procedural anxiety and acute needle fear in children. While digital distraction tools are becoming common during procedures, pre-procedural cognitive preparation strategies are limited. This randomized controlled trial investigates the impact of cognitive preparation using an AI-assisted therapeutic storytelling video.
+4
The study utilizes a prospective, single-blind, randomized controlled design. A total of 100 children (aged 4-10) with suspected respiratory allergies undergoing their first SPT will be randomized (1:1 ratio) into intervention and control groups.
- 3
- Intervention Group: Children will watch an AI-generated therapeutic storytelling video at home (the evening the appointment is made and the night before the procedure). The video, featuring characters "Ilay and Doctor Ipek", is designed to cognitively prepare the child for the procedure using age-appropriate metaphors without traumatizing elements.
- Control Group: Children will receive the clinic's standard routine care and verbal information.
- 4
Baseline anxiety is assessed using the Spence Preschool Anxiety Scale or Spence Children's Anxiety Scale. Procedural fear and pain are evaluated using the Children's Fear Scale (CFS) and the Wong-Baker FACES Scale. Behavioral responses during the procedure are observed and scored by a blinded nurse using the Children's Emotional Manifestation Scale (CEMS). The primary hypothesis is that AI-based cognitive preparation will significantly reduce pre-procedural anxiety and fear, and improve procedural compliance compared to standard care
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Video Intervention Group | Experimental | Behavioral: AI-Generated Storytelling VideoParticipants in this group will watch an AI-generated therapeutic storytelling video about the Skin Prick Test procedure at home, twice before their clinical appointment |
| Standard Care Group | Active comparator | Other: Standard Clinic CareParticipants in this group will receive standard routine verbal information and standard clinic care prior to the procedure, without any digital preparatory intervention. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged between 4 and 10 years (from 4th birthday to 11th birthday).
- Children undergoing a Skin Prick Test (SPT) for the first time.
- Presence of suspected Allergic Rhinitis and/or Asthma.
- Cognitive ability to understand Turkish, follow the video story, and interpret visual assessment scales.
- Parents with internet access to view the digital content.
Key exclusion criteria (7 listed)
- Previous experience with Skin Prick Testing or a history of frequent medical procedures (e.g., frequent blood draws, surgeries) due to chronic illness.
- Diagnosed with Autism Spectrum Disorder, severe ADHD(attention deficit hyperactivity disorder), intellectual disability, or severe psychiatric conditions preventing cooperation.
- Significant visual or hearing impairments that prevent engagement with the video content.
- Use of anxiolytics, sedatives, or medications affecting cognitive functions within the last 24 hours.
- Chronic health problems (e.g., malignancy, immunodeficiency) that may elevate baseline anxiety levels.
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 |
|---|---|---|
| AI-Generated Storytelling VideoA customized, AI-assisted animated story video featuring child-friendly characters (Lilly and Doctor Sunny) explaining the Skin Prick Test procedure. It is watched at home the evening the appointment is made and the night before the procedure to provide cognitive preparation. | Behavioural | AI-Video Intervention Group |
| Standard Clinic CareRoutine verbal explanation of the procedure provided by the clinic staff. | Other | Standard Care Group |
Primary outcome
Baseline Anxiety Level
Time frame: Baseline
Assessed using the Spence Preschool Anxiety Scale (for ages 4-6) or Spence Children's Anxiety Scale (for ages 7-10). These validated scales measure general anxiety symptoms. Higher scores indicate higher levels of anxiety.
Acute Procedural Fear Level
Time frame: Immediately post-procedure
Assessed using the Children's Fear Scale (CFS). This scale consists of five facial expressions representing a range from neutral (0) to extreme fear (4). Higher scores indicate higher levels of acute fear.
2 secondary outcomes
Behavioral Distress During Procedure
Time frame: Periprocedural
Self-Reported Procedural Pain
Time frame: within the first 5 minutes of the 15-minute SPT reading period
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 12 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in the future published article will be shared. This includes demographic characteristics, anxiety scale scores, fear scale scores, behavioral distress scores, and pain scores, strictly after removing any personally identifiable information
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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 AI-Generated Storytelling Video and Standard Clinic Care in people with Anxiety and Fear Anxiety, run by Antalya Training and Research Hospital 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 6 inclusion and 7 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 12 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?
Baseline Anxiety Level (time frame: Baseline). The study lists 2 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 12 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.