Application of Child Life Services in Pediatric Skin Prick Test

NCT07319273 | Not Yet Recruiting

• 1 other identifier: CHFudanU1013
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypersensitivity; Pediatrics

Keywords

child life services; skin prick test; pain; anxiety; pediatric nursing

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Receive standard care during the skin prick test.

Behavioral: Standard Care (in control arm)

Child life services

EXPERIMENTAL

Receive child life services during the skin prick test.

Behavioral: child life services

Interventions

Standard Care (in control arm) BEHAVIORAL

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.

Standard of care

child life services BEHAVIORAL

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.

Child life services

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

MeSH Terms

Conditions

Hypersensitivity; Pain; Anxiety Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Xinyi RONG

CONTACT

+86 18217121721; rongxinyi0208@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two groups (intervention or control) based on visit time, with each group receiving a single intervention throughout the study.

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share