Application of Child Life Services in Pediatric Skin Prick Test

Обзор

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: 1. Can child life services alleviate children's pain and enhance procedural compliance? 2. 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.

Подробное описание

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.

Вмешательства

• Поведенческое Standard Care (in control arm)
  Nurses introduce the environment, personnel, and procedure, review the child's medical and allergy history, and confirm informed consent. The SPT is then performed according to clinical standards. After the procedure, children remain under observation, during which nurses monitor for any discomfort and provide guidance to avoid scratching the test site. Finally, nurses measure and interpret the results and provide basic health education to the child and caregivers.
• Поведенческое child life services
  Children in the intervention group receive standard care plus support from a Child Life Specialist (CLS) throughout the SPT procedure. The CLS provides age-appropriate preparation, distraction, and emotional support to both children and caregivers before, during, and after the procedure. The CLS also monitors the child's responses, helps manage any anxiety or resistance, supports caregivers emotionally, and explains test results and post-procedure care in an understandable manner.

Первичные конечные точки

• the Face, Legs, Activity, Cry, Consolability (FLACC) scale score [Срок оценки: Periprocedural]
• the Wong-Baker FACES score [Срок оценки: Periprocedural]
• the Visual Analogue Scale (VAS) score [Срок оценки: Periprocedural]
• Child procedural compliance [Срок оценки: Periprocedural]

Вторичные конечные точки (4)

• Procedure duration [Срок оценки: Periprocedural]
• Number of interruptions [Срок оценки: Periprocedural]
• Caregiver anxiety [Срок оценки: within 10 minutes after skin-prick test]
• Caregiver satisfaction [Срок оценки: within 10 minutes after skin-prick test]

Критерии участия

Критерии включения

• Meet the indications for skin prick test (SPT)
• Aged 1-18 years
• Voluntarily agree to participate in the study and provide informed consent

Критерии исключения

• Meet the contraindications for SPT
• Presence of psychiatric disorders or cognitive impairment
• Severe dysfunction of vital organs such as the heart, brain, or kidneys

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Children's Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT07319273 · CHFudanU1013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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