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

Mayo Clinic126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

126

Conditions

Pain

Interventions

Certified Child Life Specialist SupportOTHER

Provides psychosocial care to children and families confronting stressful and painful situations

Eligibility

Sex: ALLMin age: 4 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic Health System - Red Wing

Red Wing, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Post vaccine administration, approximately 1 hour

Secondary Outcomes

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.

Time frame: Post vaccine administration, approximately 1 hour

Data from ClinicalTrials.gov

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