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

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

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.

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

Data and supporting information will be available beginning 6 months after the publication of the primary manuscript and ending 5 years following article publication.

Access to the IPD and supporting documents will be granted to researchers who provide a methodologically sound proposal for secondary analyses or meta-analyses. Requests should be directed to the central contact person (Dr. Enes Onkun) via email. Upon approval of the proposal, data will be shared securely via an encrypted digital transfer method.

"The administering nurse who performs the Skin Prick Test (SPT) and acts as the outcome assessor will be blinded to the participants' group assignment. The nurse will not know whether the child watched the AI-generated cognitive preparation video prior to the procedure or is in the standard care control group. This ensures that the observational scoring of the child's behavioral distress during the procedure is unbiased."