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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorAntalya Training and Research Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Standard Clinic Care

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: AI-Video Intervention GroupExperimental treatment 1 intervention
Group B: Standard Care GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Immediately post-procedure

Secondary outcomes

1

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

Time frame
Periprocedural
2

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

Time frame
Immediately post-procedure

Other outcomes

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