The Impact of the Certified Child Life Specialist on Children's Pain During Immunizations

Study Overview
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Brief Summary
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The purpose of this study is to provide the first systematic evidence that Certified Child Life Specialists reduce pain during vaccine administration and improve caregiver visit satisfaction in the pediatric primary care setting.

Official Title
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The Impact of the Certified Child Life Specialist in the Pediatric Primary Care Clinic on Children's Pain During Routine Immunizations

Conditions
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Pain

Intervention / Treatment
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* Other: Certified Child Life Specialist Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 4-12 years of age presenting to MCHS Red Wing for a well child examination and vaccine administration. Parents or caregivers of any age presenting to well child examination with child. Legal guardians of all participants must provide verbal consent. Patients must provide verbal assent for participation.Verbal assent will be waived for children younger than 6 years. Exclusion Criteria: Children with autism or other severe developmental disabilities. Children must be able to communicate pain before and after vaccine administration using the FPS-R.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunization Administration with Certified Child Life Specialist Support (CCLS)<br>Nursing will administer immunizations to children with the support of a CCLS | Other: Certified Child Life Specialist Support<br>* Provides psychosocial care to children and families confronting stressful and painful situations<br>|
| No Intervention: Current Standard of Care for Immunization Administration<br>Nursing will administer immunizations to children per their current standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported pain | Measured using the Faces Pain Scale-Revised (FPS-R). This is a self-report measure of pain validated for children ages 4-16 years of age and approved for the assessment of pediatric pain at Mayo Clinic. The scale utilizes different faces to score the sensation of pain on a 0-to-10 metric. | Post vaccine administration, approximately 1 hour | 
| Observed Negative Emotional Responses | Measured using the Children's Emotional Manifestation Scale (CEMS). The CEMS consists of five categories (facial expression, vocalization, activity, interaction, and level of cooperation) with each category scored from 1 to 5, with summed scores from 5 to 25. Higher scores represent more negative emotional behaviors. The scale was initially validated for children 7-12 years of age but has been subsequently used by other studies for children as young as 4 years of age. | Post vaccine administration, approximately 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver visit satisfaction | Measured by a caregiver satisfaction survey. This is a self-report 6-item survey to rate satisfaction level during child's immunization on a scale of 1=very satisfied and 5=dissatisfied. | Post vaccine administration, approximately 1 hour |