RECRUITING

ShotBlocker During Intramuscular Injection Randomized Control Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this trial is to evaluate the effect of Bionix ShotBlocker on pain of injection of the first Hepatitis B vaccine in healthy newborns. ShotBlocker is a pain reducing tool used in babies, children, and adults for injections. Swaddling during the injection and administration of oral sucrose prior to the injection are established standards of care for painful procedures in neonates. The investigators hypothesize that the use of ShotBlocker in addition to swaddling and oral sucrose administration will lessen the pain response.

Official Title

The Effect of ShotBlocker on Pain in Full Term Infants Undergoing Intramuscular Injection: a Randomized Controlled Trial

Quick Facts

Study Start:2024-01-10
Study Completion:2025-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06624176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:37 Weeks to 42 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Infants born at UMass Memorial Medical Center (UMMMC) via vaginal delivery or cesarean delivery and under the care of the nursery team
  2. * Term infants (37 to 42 weeks gestational age)
  3. * No acute illness that causes pain
  4. * Apgar score above 7 at 5 minutes
  5. * Have successfully attempted at least one oral feeding
  6. * No circumcision in the last 6 hours
  7. * Parental consent for Hepatitis B vaccine
  1. * Swallow dysfunction
  2. * Congenital or genetic abnormalities
  3. * Infants who were exposed to sedatives within the last 12 hours
  4. * Infants with skin on thigh, hand, or foot that is not intact
  5. * Diagnosis of Neonatal Abstinence Syndrome (NAS)
  6. * Infants who are simultaneously receiving Hepatitis B Immunoglobulin or Nirsevimab (RSV vaccine)
  7. * Department of Children and Families (DCF) custody

Contacts and Locations

Study Contact

Madeline French, BS MBE
CONTACT
5088870106
madeline.french2@umassmed.edu
Samia Binta Rahman, MBBS MPH
CONTACT
6034179792
samiabinta.rahman6@umassmed.edu

Principal Investigator

Lauren Fortier, CPNP, MSN
PRINCIPAL_INVESTIGATOR
Pediatric Nurse Practitioner for the Department of Pediatrics & PICU

Study Locations (Sites)

UMass Memorial Medical Center- Memorial Campus
Worcester, Massachusetts, 01605
United States

Collaborators and Investigators

Sponsor: Lauren Fortier

  • Lauren Fortier, CPNP, MSN, PRINCIPAL_INVESTIGATOR, Pediatric Nurse Practitioner for the Department of Pediatrics & PICU

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-10
Study Completion Date2025-04-15

Study Record Updates

Study Start Date2024-01-10
Study Completion Date2025-04-15

Terms related to this study

Keywords Provided by Researchers

  • ShotBlocker
  • Neonatal Pain
  • Needlestick

Additional Relevant MeSH Terms

  • Neonatal Pain