Application of Child Life Services in Pediatric Skin Prick Test
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- the Face, Legs, Activity, Cry, Consolability (FLACC) scale score
研究概览
简要总结
The goal of this clinical trial is to determine whether child life services can enhance the experiences of children and caregivers during skin prick testing. The main questions it aims to answer are:
- Can child life services alleviate children's pain and enhance procedural compliance?
- Can child life services reduce caregivers' anxiety and improve their satisfaction? Researchers will compare children who receive child life services with those who receive standard care to determine whether the intervention can optimize procedural experience and overall satisfaction.
Participants will receive either child life services or standard care during the skin prick test.
详细描述
The skin prick test (SPT) is an essential diagnostic tool for IgE-mediated allergic diseases and a foundation for allergen immunotherapy. However, the multiple needle pricks involved often cause pain and anxiety in children, while caregivers frequently experience heightened stress. Child life services aim to help children feel safe and relaxed in medical settings, thereby reducing distress and improving cooperation. This study applied child life services during pediatric SPT to alleviate children's pain, boost procedural compliance, reduce procedural duration and interruptions, and enhance caregiver satisfaction while alleviating their anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the indications for skin prick test (SPT)
- •Aged 1-18 years
- •Voluntarily agree to participate in the study and provide informed consent
排除标准
- •Meet the contraindications for SPT
- •Presence of psychiatric disorders or cognitive impairment
- •Severe dysfunction of vital organs such as the heart, brain, or kidneys
研究组 & 干预措施
Standard of care
Receive standard care during the skin prick test.
干预措施: Standard Care (in control arm) (Behavioral)
Child life services
Receive child life services during the skin prick test.
干预措施: child life services (Behavioral)
结局指标
主要结局
the Face, Legs, Activity, Cry, Consolability (FLACC) scale score
时间窗: Periprocedural
Use the FLACC scale to assess pain, higher scores indicate greater pain (0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain).
the Wong-Baker FACES score
时间窗: Periprocedural
Use the Wong-Baker FACES scale to assess pain, higher scores indicate greater pain (0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain).
the Visual Analogue Scale (VAS) score
时间窗: Periprocedural
Use the Visual Analogue Scale (VAS) to assess pain, higher scores indicate greater pain (0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain).
Child procedural compliance
时间窗: Periprocedural
During the skin-prick test, compliance was rated as: Full: complete cooperation with the nurse; Partial: test completed despite crying or resistance; None: test impossible owing to non-copliance Overall compliance rate = (full + partial) / total × 100%. A higher overall compliance rate indicates better overall compliance with the skin-prick test procedure.
次要结局
- Procedure duration(Periprocedural)
- Number of interruptions(Periprocedural)
- Caregiver anxiety(within 10 minutes after skin-prick test)
- Caregiver satisfaction(within 10 minutes after skin-prick test)