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NCT Number: NCT07319273

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.

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Key information

Conditions

Hypersensitivity Anxiety Disorders Immune System Diseases Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pediatrics Signs and Symptoms

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. the Face, Legs, Activity, Cry, Consolability (FLACC) scale score

    Time frame: Periprocedural

    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).

  2. the Wong-Baker FACES score

    Time frame: Periprocedural

    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).

  3. the Visual Analogue Scale (VAS) score

    Time frame: Periprocedural

    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).

  4. Child procedural compliance

    Time frame: Periprocedural

    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.

Secondary outcomes

  1. Procedure duration

    Time frame: Periprocedural

  2. Number of interruptions

    Time frame: Periprocedural

  3. Caregiver anxiety

    Time frame: within 10 minutes after skin-prick test

    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).

  4. Caregiver satisfaction

    Time frame: within 10 minutes after skin-prick test

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xinyi RONG

CONTACT

[email protected]

+86 18217121721

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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