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

Mayo Clinic

Status: Completed

Conditions: Pain

Treatments: Other: Certified Child Life Specialist Support

Study type: Interventional

Funder types: Other

Identifiers

NCT05285254

21-002328

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Immunization Administration with Certified Child Life Specialist Support (CCLS)

Experimental group

Description:

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

Treatment:

Other: Certified Child Life Specialist Support

Current Standard of Care for Immunization Administration

No Intervention group

Description:

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