Effects of Shotblocker® and Manual Pressure on Pain

NCT06813729 | Completed Phase 4

• 1 other identifier: E-79593712-605.99
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers; Infant; Vaccine; Pain

Keywords

pain; vaccine; shotblocker; manuel pressure; infant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

The Shotblocker® Group

EXPERIMENTAL

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 Manuel Pressure Group

EXPERIMENTAL

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 Control Group

NO INTERVENTION

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).

Interventions

Shotblocker BIOLOGICAL

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.

The Shotblocker® Group

Manuel Pressure BIOLOGICAL

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).

The Manuel Pressure Group

Eligibility Criteria

• Age: 4 Months - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Soma Family Health Center No. 3

Manisa, 45010, Turkey (Türkiye)

Location

Related Publications (1)

• Kislali Tas S, Sari D, Taskiran N. Reducing Vaccination Pain in Infants: A Randomized Controlled Trial on the Effects of ShotBlocker and Manual Pressure. Clin Pediatr (Phila). 2025 Oct 29:99228251387875. doi: 10.1177/00099228251387875. Online ahead of print.

  PMID: 41159533 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Infants who met the inclusion criteria and were scheduled for the PCV vaccine injection were assigned to one of three groups: Shotblocker®, manual pressure, or a control group (which received the standard injection technique). To address gender differences, infants were first categorized by gender and then randomly assigned to the three groups using block randomization. To ensure fairness and minimize bias, labels for each group (Shotblocker®, manual pressure, and control) were written on papers of the same color and shape, placed into separate pink and blue boxes. During the vaccination process, the group assignment was determined by a lottery that the mother drew from just before the procedure. Mothers of girls were instructed to draw from the pink box, while mothers of boys drew from the blue box. Each group consisted of 34 infants, with an equal distribution of 17 females and 17 males.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aydin Adnan Menderes University

Model Details: A Randomized Controlled Trial

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 7, 2025
• Study Start: February 15, 2022
• Primary Completion: June 15, 2023
• Study Completion: November 15, 2023
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)