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

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

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 Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Certified Child Life Specialist Support

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Red Wing, Minnesota, United States, 55066
      • Mayo Clinic Health System - Red Wing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Seth Gregory, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 21-002328

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No