An interventional study of Standard Care (in control arm) and child life services in Hypersensitivity and Pediatrics, sponsored by Children's Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Supportive care
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:
Participants will receive either child life services or standard care during the skin prick test.
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.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 140 is above the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receive standard care during the skin prick test.
Behavioral: Standard Care (in control arm)
Receive child life services during the skin prick test.
Behavioral: child life services
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.
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.
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
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
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
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
Procedure duration
Time frame: Periprocedural
Number of interruptions
Time frame: 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).
Time frame: 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.
Time frame: within 10 minutes after skin-prick test
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Sep 2026, 6 months after the start.
Of 150 non-industry interventional studies with no phase under Hypersensitivity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 6 months is below that.
Counting every sponsor, half of 174 studies reached it within 20 months; a quarter within 5 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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