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Recruiting Not applicable

Application of Child Life Services in Pediatric Skin Prick Test

NCT07319273 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-03-01
Last updated
2026-07-06

Condition(s) studied

HypersensitivityPediatrics

Investigational drug(s) / intervention(s)

Standard Care (in control arm)child life services

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.

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Meet the indications for skin prick test (SPT) * Aged 1-18 years * Voluntarily agree to participate in the study and provide informed consent Exclusion Criteria: * Meet the contraindications for SPT * Presence of psychiatric disorders or cognitive impairment * Severe dysfunction of vital organs such as the heart, brain, or kidneys

Primary outcome measure(s)

  • the Face, Legs, Activity, Cry, Consolability (FLACC) scale score — 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 — 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 — 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 — 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.

Trial sites (1)

FacilityCityRegionStatus
Children's Hospital of Fudan University Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07319273 on ClinicalTrials.gov ↗ ← All trials in China