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Completed

NCT Number: NCT06813729

Effects of Shotblocker® and Manual Pressure on Pain

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.

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Key information

Age range

4 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soma Family Health Center No. 3

Manisa, 45010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Pain mean score

    Time frame: immediately after the pneumococcal conjugate vaccination

    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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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