An interventional study of Certified Child Life Specialist Support in Pain, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 4 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-17.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 126 is above the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
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Exclusion Criteria:
Nursing will administer immunizations to children with the support of a CCLS
Other: Certified Child Life Specialist Support
Nursing will administer immunizations to children per their current standard of care.
Provides psychosocial care to children and families confronting stressful and painful situations
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.
Time frame: 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.
Time frame: Post vaccine administration, approximately 1 hour
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.
Time frame: Post vaccine administration, approximately 1 hour
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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