NCT07319273

Application of Child Life Services in Pediatric Skin Prick Test

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hypersensitivity
• Pediatrics

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2026-01-06
• Last updated: 2026-01-06