About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
AI-Generated Storytelling Video
BehavioralA 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.
Standard Clinic Care
Other interventionRoutine verbal explanation of the procedure provided by the clinic staff.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Behavioral Distress During Procedure
Assessed by a blinded observer nurse 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
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
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