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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05285254
• Other study ID #: 21-002328
• Status: Completed
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: March 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Certified Child Life Specialist Support
Provides psychosocial care to children and families confronting stressful and painful situations

Locations

Country	Name	City	State
United States	Mayo Clinic Health System - Red Wing	Red Wing	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials