Health TrialsbyHealthPanel

Application of Child Life Services in Pediatric Skin Prick Test

ConditionsHypersensitivityPediatrics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorChildren's Hospital of Fudan University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Meet the indications for skin prick test (SPT)

Aged 1-18 years

Voluntarily agree to participate in the study and provide informed consent

Disqualifiers

Meet the contraindications for SPT

Presence of psychiatric disorders or cognitive impairment

Severe dysfunction of vital organs such as the heart, brain, or kidneys

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Standard of careActive comparator 1 intervention
Group B: Child life servicesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Periprocedural
2

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).

Time frame
Periprocedural
3

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).

Time frame
Periprocedural
4

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.

Time frame
Periprocedural

Secondary outcomes

1

Procedure duration

Time frame
Periprocedural
2

Number of interruptions

Time frame
Periprocedural
3

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).

Time frame
within 10 minutes after skin-prick test
4

Caregiver satisfaction

satisfaction was rated by caregivers on a 5-point scale: 5 = very satisfied, 4 = satisfied, 3 = neutral, 2 = dissatisfied, 1 = very dissatisfied.

Time frame
within 10 minutes after skin-prick test

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Fudan University

Lead sponsor

Source ClinicalTrials.gov
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