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

NCT07453615 | Recruiting

• 1 other identifier: 2026-36
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

Skin Prick Test; Artificial Intelligence; Cognitive Preparation; Storytelling

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Behavioral Distress During Procedure

  Periprocedural

• Self-Reported Procedural Pain

  Immediately post-procedure

Study Arms (2)

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

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.

Other: Standard Clinic Care

Interventions

AI-Generated Storytelling Video BEHAVIORAL

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.

AI-Video Intervention Group

Standard Clinic Care OTHER

Routine verbal explanation of the procedure provided by the clinic staff.

Standard Care Group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Health Sciences University Antalya Training and Research Hospital

Antalya, 07030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Rhinitis, Allergic; Asthma; Disease

Condition Hierarchy (Ancestors)

Mental Disorders; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Enes Enes, MD

CONTACT

+905467328454; enesonkn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: "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."
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

TU (1)