Actively Recruiting
AI-Based Video-Mediated Cognitive Preparation in Skin Prick Testing: A Prospective, Randomized Controlled Trial
Led by Antalya Training and Research Hospital · Updated on 2026-03-18
100
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the impact of an AI-generated therapeutic storytelling video on reducing anxiety and fear in children aged 4 to 10 years who are undergoing their first Skin Prick Test (SPT). The trial focuses on children suspected of having respiratory allergies such as allergic rhinitis or asthma. The goal is to determine whether watching this cognitive preparation video at home before the appointment can lower pre-procedural anxiety compared to the usual care. Participants are randomly assigned to one of two groups. The intervention group watches a specially designed AI-assisted animated video featuring child-friendly characters explaining the SPT procedure at home twice: once on the evening the appointment is made and again the night before the test. The control group receives the standard clinic care, which includes routine verbal information about the procedure. The study uses a prospective, single-blind, randomized controlled design with 100 children. During the study, baseline anxiety is measured using age-appropriate anxiety scales. After the procedure, fear and pain levels are assessed with validated scales, and behavioral distress during the test is observed by a blinded nurse. The primary outcomes include baseline anxiety and acute fear immediately after the procedure. Secondary outcomes include behavioral distress and self-reported pain. The study monitors adherence by ensuring the video is watched and validated. Participation lasts through the appointment and assessments around the procedure date.
CONDITIONS
Brief Title
Effect of AI(Artificial Intelligence)-Based Storytelling Video on Anxiety and Fear During Skin Prick Test in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged between 4 and 10 years (from 4th birthday to 11th birthday).
- Children undergoing a Skin Prick Test (SPT) for the first time.
- Suspected allergic rhinitis and/or asthma diagnosis.
- Cognitive ability to understand Turkish, follow the video story, and interpret visual assessment scales.
- Parents or guardians have internet access to view digital content.
- Obtained parental informed consent and child assent (for children aged 7 and above).
You will not qualify if you...
- Previous experience with Skin Prick Testing or frequent medical procedures due to chronic illness.
- Diagnosed with Autism Spectrum Disorder, severe ADHD, intellectual disability, or severe psychiatric conditions preventing cooperation.
- Significant visual or hearing impairments preventing engagement with video content.
- Use of anxiolytics, sedatives, or cognitive-affecting medications within the last 24 hours.
- Chronic health problems such as malignancy or immunodeficiency that may raise baseline anxiety.
- Undergoing SPT for suspected food, drug, or bee venom allergies.
- For the intervention group: failure to watch the video or incorrect answers to validation questions on procedure day.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 days before the procedure
Participants in the intervention group watch an AI-generated therapeutic storytelling video at home twice to prepare for the Skin Prick Test. The control group receives standard verbal information from clinic staff.
No visits; video watched at home
Duration - 1 day
Participants undergo the Skin Prick Test to assess allergies while anxiety, fear, pain, and behavioral responses are measured.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Health Sciences University Antalya Training and Research Hospital
Antalya, Turkey (Türkiye), 07030
Actively Recruiting
Research Team
E
Enes Enes, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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