Pain
Conditions
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.
Interventions
OTHERCertified Child Life Specialist Support
Provides psychosocial care to children and families confronting stressful and painful situations
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported pain | 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. |
| Observed Negative Emotional Responses | 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
| Measure | Time frame | Description |
|---|---|---|
| Caregiver visit satisfaction | 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. |
Countries
United States
Outcome results
None listed