Effects of Shotblocker® and Manual Pressure on Pain

Phase 4

Completed

• Conditions: Healthy Volunteers; Infant; Vaccine; Pain
• Interventions: Biological: Shotblocker; Biological: Manuel Pressure

• Registration Number: NCT06813729
• Lead Sponsor: Aydin Adnan Menderes University

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.

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 Timeline

• Study Start: 2022-02-15
• Primary Completion: 2023-06-15
• Study Completion: 2023-11-15
• Study First Submitted: 2025-01-29
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
The Shotblocker® Group	Shotblocker	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.
The Manuel Pressure Group	Manuel Pressure	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

Primary Outcome Measures

Name	Time	Method
Pain mean score	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.

Trial Locations

Locations (1)

Soma Family Health Center No. 3; 🇹🇷 Manisa, Turkey