Health Sciences University Antalya Training and Research Hospital
Antalya, 07030, Turkey (Türkiye)
NCT Number: NCT07453615
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
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Notify Me4 year–10 year
All sexes
Interventional
Not applicable
Antalya, 07030, Turkey (Türkiye)
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.
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Routine verbal explanation of the procedure provided by the clinic staff.
Time frame: Baseline
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.
Time frame: Immediately post-procedure
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.
Time frame: Periprocedural
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
Time frame: Immediately post-procedure
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
Antalya Training and Research Hospital
Other Gov
AI-Based Video-Mediated Cognitive Preparation in Skin Prick Testing: A Prospective, Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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