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Completed

NCT Number: NCT05285254

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

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Key information

Conditions

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

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Health System - Red Wing

Red Wing, Minnesota, 55066, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Certified Child Life Specialist Support

Other

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

Primary outcomes

  1. Patient-reported pain

    Time frame: Post vaccine administration, approximately 1 hour

    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.

  2. Observed Negative Emotional Responses

    Time frame: Post vaccine administration, approximately 1 hour

    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.

Secondary outcomes

  1. Caregiver visit satisfaction

    Time frame: Post vaccine administration, approximately 1 hour

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2022
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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