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

NCT05285254 | Completed

• 1 other identifier: 21-002328
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Caregiver visit satisfaction

  Post vaccine administration, approximately 1 hour

Study Arms (2)

Immunization Administration with Certified Child Life Specialist Support (CCLS)

EXPERIMENTAL

Nursing will administer immunizations to children with the support of a CCLS

Other: Certified Child Life Specialist Support

Current Standard of Care for Immunization Administration

NO INTERVENTION

Nursing will administer immunizations to children per their current standard of care.

Interventions

Certified Child Life Specialist Support OTHER

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

Immunization Administration with Certified Child Life Specialist Support (CCLS)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children with autism or other severe developmental disabilities.
• Children must be able to communicate pain before and after vaccine administration using the FPS-R.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Health System - Red Wing

Red Wing, Minnesota, 55066, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seth Gregory, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 17, 2022
• Study Start: June 28, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

US (1)