Application of Child Life Services in Pediatric Skin Prick Test

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypersensitivity; Pediatrics
• Intervention / Treatment: Behavioral: Standard Care (in control arm); Behavioral: child life services

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinyi Rong; Phone Number: +86 18217121721; Email: rongxinyi0208@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; Receive standard care during the skin prick test.	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.
Experimental: Child life services; Receive child life services during the skin prick test.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Face, Legs, Activity, Cry, Consolability (FLACC) scale score	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).	Periprocedural
the Wong-Baker FACES score	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).	Periprocedural
the Visual Analogue Scale (VAS) score	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).	Periprocedural
Child procedural compliance	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.	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure duration		Periprocedural
Number of interruptions		Periprocedural
Caregiver anxiety	Caregiver anxiety was assessed with the 10-item short-form State-Trait Anxiety Inventory (five state and five trait items); each item is scored 1-4, with higher total scores indicating greater anxiety (Cronbach's α = 0.918).	within 10 minutes after skin-prick test
Caregiver satisfaction	satisfaction was rated by caregivers on a 5-point scale: 5 = very satisfied, 4 = satisfied, 3 = neutral, 2 = dissatisfied, 1 = very dissatisfied.	within 10 minutes after skin-prick test

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: pain; anxiety; skin prick test; pediatric nursing; child life services
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Immune System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders; Hypersensitivity; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: CHFudanU1013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No