Effects of Shotblocker® and Manual Pressure on Pain

Effects of Shotblocker® and Manual Pressure on Pain During the Administration of Vaccine in Infants

Aim This randomized controlled experimental study was conducted to determine the effect of ShotBlocker® and manual pressure application on pain in the application of Conjugated Pneumococcal Vaccine (PCV).

The following hypotheses were determined for the study; Hypothesis 1: Pain scores of infants are lower in the manual pressure group than in the control group during the administration of PCV.

Hypothesis 2: Pain scores of infants are lower in Shotblocker® group than in the control group during the administration of PCV.

Hypothesis 3: Manual pressure is more effective than Shotblocker® in infants to reducing pain during the administration of PCV.

Study Overview

• Status: Completed
• Conditions: Pain; Healthy Volunteers; Infant; Vaccine
• Intervention / Treatment: Biological: Shotblocker; Biological: Manuel Pressure

Detailed Description

The study was carried out at three family health centers, all with the same nurse administering care. Infant who were 4 months old and scheduled to receive the PCV vaccine were eligible for participation. The data were collected using a questionnaire form and the Neonatal Infant Pain Scale (NIPS).

A standard procedure was followed for all infants, which included bringing the infant and mothers into the vaccination room, providing information about the vaccine, introducing the researcher, and obtaining informed consent. Infants were assigned to groups based on randomization. To control factors related to the application process (such as injection technique and communication approach), vaccines were administered by same experienced nurse working at the family center where the research was conducted.

A video camera with a 5X optical zoom support (Samsung M51 brand smartphone) was used to record vaccine injections. It was placed on a tripod across the stretcher where the infants were vaccinated. Each infant was recorded for during vaccination, and 2 min after vaccination.

Written approval was obtained from the Ethics Committee (2021/279) and institution where the study was conducted (E-79593712-605.99). The nurse researcher informed infants' mothers about the study. Upon agreement from mothers, written consent forms were obtained.

Data were analyzed using SPSS for Windows version 25.0 (IBM, Armonk, NY). Numeric variables are presented as counts, percentages, means, standard deviations, and min-max values. The assumption of normal distribution was checked with the Shapiro-Wilk test, and the assumption of homogeneity of variances was controlled with the Levene test. To compare pain scores after vaccination, a paired sample t-test was used. In cases where the data showed a normal distribution and there were more than two independent groups, a one-way analysis of variance (ANOVA) test was employed. A significance level of p < .05 was considered statistically significant.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Manisa, Turkey, 45010
    • Soma Family Health Center No. 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Infant who were 4 months old
• who receive the pneumococcal conjugate vaccine receive
• healthly infant, free from systemic illnesses
• accompanied by their mothers
• attending the center for routine vaccination

Exclusion Criteria:

• who have serious congenital malformations
• who have neurodevelopmental delays
• who have serious congenital malformations
• who have febrile conditions
• who have a history of circulatory or peripheral vascular issues
• who had taken sedatives, hypnotics, or systemic pain relievers within the last 6 hours
• infant who cried before receiving the vaccine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Shotblocker® Group; Shotblocker® is a small, flexible plastic device designed to be drug-free, featuring multiple rounded points on the bottom that come into contact with the skin. It also has a central hole for injection administration.	Biological: Shotblocker; The infant was first placed on the examination table. To calm the infant, the mother was asked to hold the infants' hands and talk to him/her. Before the injection, while one nurse held the infants' leg for the injection, Shotblocker® was applied to the skin by the experienced nurse ensuring that the points were in direct contact. Then, the nurse administered the pneumococcal conjugate vaccine (0.5 ml, IM, Vastus Lateralis Site) through the central hole. After each use, the Shotblocker® was disinfected with 70% alcohol before being used on another infant.
Experimental: The Manuel Pressure Group; nurse held the infants' leg for the injection, 10-second manual pressure was applied on the vaccine injection site by the experienced nurse before pneumococcal conjugate vaccine	Biological: Manuel Pressure; The infant was first placed on the examination table. To calm the infant, the mother was asked to hold the infants' hands and talk to him/her. Next, while one nurse held the infants' leg for the injection, 10-second manual pressure was applied on the vaccine injection site by the experienced nurse. Then pneumococcal conjugate vaccine was administered in accordance with the standard injection technique (0.5 ml, IM, Vastus Lateralis Site).
No Intervention: The Control Group; The infant was first placed on the examination table. To calm the infant, the mother was asked to hold the infants' hands and talk to him/her. Distraction method was not employed for the infants in this group, and while one nurse held the infants' leg for the injection, the experienced nurse administered the pneumococcal conjugate vaccine (0.5 ml, IM, Vastus Lateralis Site).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain mean score	The Neonatal Infant Pain Scale total mean score of infants are lower in the manual pressure and shotbocker groups than in the control group during the administration of PCV.	immediately after the pneumococcal conjugate vaccination

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: pain; vaccine; infant; shotblocker; manuel pressure
• Other Study ID Numbers: E-79593712-605.99

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
• product manufactured in and exported from the U.S.: No