The Effect of ShotBlocker on Pain and Satisfaction During Measles-Rubella-Mumps Vaccination

January 7, 2025 updated by: Veysel Can, Yuzuncu Yıl University

Objective The aim of this study was to evaluate the effects of ShotBlocker administration during measles-mumps-rubella (MMR) vaccination on infants' pain level and mothers' satisfaction.

Method. The study was conducted in a Family Health Center affiliated to the Public Health Directorate of a province in eastern Turkey between August and October 2024 using a randomized controlled experimental design. The study sample consisted of 60 infants who received MMR vaccination (ShotBlocker group: n = 30, control group: n = 30). Infants in the ShotBlocker group received ShotBlocker before vaccine injection, while infants in the control group received only routine vaccine injection. Infant information form, FLACC pain scale and Newcastle Satisfaction with Nursing Care Scale were used for data collection. Ethical principles were followed throughout the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Tuşba
      • VAN, Tuşba, Turkey, 65000
        • Van Yuzuncu Yıl University

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.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • He's 12 months old,
  • MMR vaccine will be administered,
  • growth-development is normal,
  • no analgesic medication was given during the day,
  • at least high school graduate
  • mothers who volunteered to participate in the study

Exclusion Criteria:

  • Neurological disease,
  • a chronic disease,
  • allergy (egg allergy)
  • infants with symptoms of hyperthermia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: ShotBlocker
Behavioral: ShotBlocker
Apply ShotBlocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Face, Legs, Activity, Crying, Consolability Pain Scala
Time Frame: pre-test post-test (approximately three months)
min-max (0-10), lower score means better result, reduce scale scores
pre-test post-test (approximately three months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

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 Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

November 20, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

December 31, 2024

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShotBlocker

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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