HypersensitivityNCT07319273
Application of Child Life Services in Pediatric Skin Prick Test
A study testing child life services in people with Hypersensitivity and Pediatrics, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Can child life services alleviate children's pain and enhance procedural compliance? 2. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Hypersensitivity, Pediatrics
- What is being tested?
- child life services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meet the indications for skin prick test (SPT)
- Aged 1-18 years
- Voluntarily agree to participate in the study and provide informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, 201102
Ying Gu, +86 13816881726, guying0128@aliyun.com
About this study
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:
- Can child life services alleviate children's pain and enhance procedural compliance?
- 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.
Read the 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.
- Conditions
- Hypersensitivity, Pediatrics
- Being tested
- Standard Care (in control arm), child life services
- Keywords
- child life services, skin prick test, pain, anxiety, pediatric nursing
- Medical subject headings
- Hypersensitivity, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care (in control arm)Behavioural
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 servicesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Receive standard care during the skin prick test. Receives: Behavioral: Standard Care (in control arm) |
| Child life services | Experimental | Receive child life services during the skin prick test. Receives: Behavioral: child life services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Periprocedural
Secondary outcomes (4)
Procedure duration
Measured: Periprocedural
Number of interruptions
Measured: 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).
Measured: 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.
Measured: within 10 minutes after skin-prick test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319273
- Sponsor's protocol ID
- CHFudanU1013
- Status last verified
- Jul 2026
- First submitted
- 16 Nov 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Child Life Services in Pediatric Skin Prick Test
- ClinicalTrials.gov ID
- NCT07319273
- Acronym / sponsor ID
- CHFudanU1013
- Conditions
- Hypersensitivity, Pediatrics
- Keywords
- child life services, skin prick test, pain, anxiety, pediatric nursing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can child life services alleviate children's pain and enhance procedural compliance?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Behavioral: Standard Care (in control arm)Receive standard care during the skin prick test. |
| Child life services | Experimental | Behavioral: child life servicesReceive child life services during the skin prick test. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Meet the indications for skin prick test (SPT)
- Aged 1-18 years
- Voluntarily agree to participate in the study and provide informed consent
Key exclusion criteria (3 listed)
- Meet the contraindications for SPT
- Presence of psychiatric disorders or cognitive impairment
- Severe dysfunction of vital organs such as the heart, brain, or kidneys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Standard of care |
| child life servicesChildren 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. | Behavioural | Child life services |
Primary outcome
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).
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).
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).
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing child life services in people with Hypersensitivity and Pediatrics, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyi RONG (+86 18217121721, rongxinyi0208@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Face, Legs, Activity, Cry, Consolability (FLACC) scale score (time frame: Periprocedural). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.