Application of Child Life Services in Pediatric Skin Prick Test
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Care (in control arm), child life services.
- Who it may be relevant to
- Registry conditions: Hypersensitivity, Pediatrics. Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- the Face, Legs, Activity, Cry, Consolability (FLACC) scale score [Time frame: Periprocedural]
- the Wong-Baker FACES score [Time frame: Periprocedural]
- the Visual Analogue Scale (VAS) score [Time frame: Periprocedural]
- Child procedural compliance [Time frame: Periprocedural]
Secondary outcome measures (4)
- Procedure duration [Time frame: Periprocedural]
- Number of interruptions [Time frame: Periprocedural]
- Caregiver anxiety [Time frame: within 10 minutes after skin-prick test]
- Caregiver satisfaction [Time frame: within 10 minutes after skin-prick test]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
China · 1 center
- Children's Hospital of Fudan University — Shanghai
Identifiers
NCT: NCT07319273 · CHFudanU1013