PainNCT05285254
The Impact of the Certified Child Life Specialist on Children's Pain During Immunizations
A study testing Certified Child Life Specialist Support in people with Pain, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Certified Child Life Specialist Support
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2021to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Health System - Red Wing
Red Wing, Minnesota, 55066
About this study
Official title: The Impact of the Certified Child Life Specialist in the Pediatric Primary Care Clinic on Children's Pain During Routine 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.
- Conditions
- Pain
- Being tested
- Certified Child Life Specialist Support
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certified Child Life Specialist SupportOther
Provides psychosocial care to children and families confronting stressful and painful situations
| Study group | Role | What they receive |
|---|---|---|
| Immunization Administration with Certified Child Life Specialist Support (CCLS) | Experimental | Nursing will administer immunizations to children with the support of a CCLS Receives: Other: Certified Child Life Specialist Support |
| Current Standard of Care for Immunization Administration | No intervention | Nursing will administer immunizations to children per their current standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post vaccine administration, approximately 1 hour
Secondary outcomes (1)
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.
Measured: Post vaccine administration, approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start28 Jun 2021
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth W. Gregory, Mayo Clinic
- Investigators
- Seth Gregory, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285254
- Sponsor's protocol ID
- 21-002328
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Certified Child Life Specialist in the Pediatric Primary Care Clinic on Children's Pain During Routine Immunizations
- ClinicalTrials.gov ID
- NCT05285254
- Acronym / sponsor ID
- 21-002328
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunization Administration with Certified Child Life Specialist Support (CCLS) | Experimental | Other: Certified Child Life Specialist SupportNursing will administer immunizations to children with the support of a CCLS |
| Current Standard of Care for Immunization Administration | No intervention | –Nursing will administer immunizations to children per their current standard of care. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Children with autism or other severe developmental disabilities.
- Children must be able to communicate pain before and after vaccine administration using the FPS-R.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certified Child Life Specialist SupportProvides psychosocial care to children and families confronting stressful and painful situations | Other | Immunization Administration with Certified Child Life Specialist Support (CCLS) |
Primary outcome
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.
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.
1 secondary outcome
Caregiver visit satisfaction
Time frame: Post vaccine administration, approximately 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth Gregory, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Certified Child Life Specialist Support in people with Pain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported pain (time frame: Post vaccine administration, approximately 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.