AI storytelling video to reduce anxiety for children having their first skin prick test
AI-Based Video-Mediated Cognitive Preparation in Skin Prick Testing: A Prospective, Randomized Controlled Trial
This project will test whether an AI-made storytelling video watched at home helps children aged 4–10 feel less anxious before their first skin prick allergy test.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | Antalya Training and Research Hospital Government |
| Locations | 1 site (Antalya) |
| Trial ID | NCT07453615 on ClinicalTrials.gov |
What this trial studies
This single-blind, randomized controlled study will enroll 100 children aged 4–10 undergoing their first skin prick test for suspected allergic rhinitis or asthma and randomize them 1:1 to an AI-generated therapeutic storytelling video or standard clinic care. The intervention group watches the video at home the evening the appointment is made and the night before the procedure while the control group receives routine verbal information. Anxiety and baseline symptoms are measured with the Spence preschool/children's anxiety scales, and procedural fear, pain, and behavior are measured with the Children's Fear Scale, Wong-Baker FACES, and a blinded nurse's observation. The aim is to see if pre-procedural cognitive preparation with an age-appropriate AI story reduces fear and improves the testing experience.
Who should consider this trial
Good fit: Children aged 4 to 10 having their first skin prick test for suspected allergic rhinitis or asthma who understand Turkish and whose parents can access the online video are ideal candidates.
Not a fit: Children with prior SPT experience, significant sensory impairments, autism spectrum disorder, severe ADHD, intellectual disability, or current use of sedatives/anxiolytics are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the video could lower pre-procedural anxiety and needle fear, making the skin prick test less distressing for children and easier for families and clinic staff.
How similar studies have performed: Prior work using distraction and preparatory videos has shown reductions in pediatric procedural anxiety, but AI-generated therapeutic storytelling in this specific format is a relatively new approach with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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.
Where this trial is running
Antalya
- Health Sciences University Antalya Training and Research Hospital — Antalya, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Enes Enes, MD
- Email: enesonkn@gmail.com
- Phone: +905467328454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.