The Effect of Certified Child Life Specialist Support on Children's Pain During Immunizations
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Red Wing, Minnesota: 21-002328
About this study
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.
A secondary aim will be to record what specific interventions are utilized by the CCLS during vaccine administration and its relation to patient-reported pain and caregiver visit satisfaction.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Red Wing, Minn.
Mayo Clinic principal investigator Seth Gregory, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available