NCT07453615

Effect of AI(Artificial Intelligence)-Based Storytelling Video on Anxiety and Fear During Skin Prick Test in Children

AI-Based Video-Mediated Cognitive Preparation in Skin Prick Testing: A Prospective, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Antalya Training and Research Hospital · Other Government
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Not accepted

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). 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

Conditions

• Anxiety
• Fear Anxiety
• Allergic Rhinitis
• Asthma (Diagnosis)

Interventions

Type	Name	Description
BEHAVIORAL	AI-Generated Storytelling Video	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.
OTHER	Standard Clinic Care	Routine verbal explanation of the procedure provided by the clinic staff.

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-07-15
• Completion: 2026-09-15
• First posted: 2026-03-06
• Last updated: 2026-03-18

Locations

1 site across 1 country: Turkey (Türkiye)