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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Certified Child Life Specialist Support

• Registration Number: NCT05285254
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-28
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Status Verified: 2022-03
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-08
• Last Update Submitted: 2022-03-08
• Study First Posted: 2022-03-17
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immunization Administration with Certified Child Life Specialist Support (CCLS)	Certified Child Life Specialist Support	Nursing will administer immunizations to children with the support of a CCLS

Primary Outcome Measures

Name	Time	Method
Patient-reported pain	Post vaccine administration, approximately 1 hour	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.
Observed Negative Emotional Responses	Post vaccine administration, approximately 1 hour	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.

Secondary Outcome Measures

Name	Time	Method
Caregiver visit satisfaction	Post vaccine administration, approximately 1 hour	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.

Trial Locations

Locations (1)

Mayo Clinic Health System - Red Wing; 🇺🇸 Red Wing, Minnesota, United States