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

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

Study Overview

• Status: Completed
• Conditions: Anxiety; Allergic Rhinitis; Fear Anxiety; Asthma (Diagnosis)
• Intervention / Treatment: Behavioral: AI-Generated Storytelling Video; Other: 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.

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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.

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  • 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.
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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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Antalya, Turkey (Türkiye), 07030
    • Health Sciences University Antalya Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-Video Intervention Group; 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	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.
Active Comparator: Standard Care Group; Participants in this group will receive standard routine verbal information and standard clinic care prior to the procedure, without any digital preparatory intervention.	Other: Standard Clinic Care; Routine verbal explanation of the procedure provided by the clinic staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Immediately post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	within the first 5 minutes of the 15-minute SPT reading period

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2026
• Primary Completion (Actual): July 9, 2026
• Study Completion (Actual): July 9, 2026

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Skin Prick Test; Storytelling; Cognitive Preparation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Pathological Conditions, Signs and Symptoms; Asthma; Anxiety Disorders; Disease; Rhinitis, Allergic
• Other Study ID Numbers: 2026-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: Data and supporting information will be available beginning 6 months after the publication of the primary manuscript and ending 5 years following article publication.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No