AI-Based Video-Mediated Cognitive Preparation in Skin Prick Testing: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Baseline Anxiety Level
研究概览
简要总结
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
详细描述
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.
+4
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.
-
3
-
Intervention Group: Children will watch an AI-generated therapeutic storytelling video at home (the evening the appointment is made and the night before the procedure). The video, featuring characters "Ilay and Doctor Ipek", is designed to cognitively prepare the child for the procedure using age-appropriate metaphors without traumatizing elements.
-
Control Group: Children will receive the clinic's standard routine care and verbal information.
-
4
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
"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."
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
AI-Video Intervention Group
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
干预措施: AI-Generated Storytelling Video (Behavioral)
Standard Care Group
Participants in this group will receive standard routine verbal information and standard clinic care prior to the procedure, without any digital preparatory intervention.
干预措施: Standard Clinic Care (Other)
结局指标
主要结局
Baseline Anxiety Level
时间窗: 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.
Acute Procedural Fear Level
时间窗: 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.
次要结局
- Behavioral Distress During Procedure(Periprocedural)
- Self-Reported Procedural Pain(within the first 5 minutes of the 15-minute SPT reading period)