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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunization Administration with Certified Child Life Specialist Support (CCLS) | Experimental | Nursing will administer immunizations to children with the support of a CCLS |
|
| Current Standard of Care for Immunization Administration | No Intervention | Nursing will administer immunizations to children per their current standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certified Child Life Specialist Support | Other | Provides psychosocial care to children and families confronting stressful and painful situations |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth Gregory, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System - Red Wing | Red Wing | Minnesota | 55066 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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