Rapid Injection Technique Without Aspiration

The Effect of the Rapid Injection Technique Without Aspiration on Pain Level in Intramuscular Vaccination- A Single-blind Randomized Controlled Trial

This experimental, single-blind, randomized controlled trial study was conducted to compare the effect of the rapid injection technique without aspiration on pain level in the vaccination for the young adult students. The population of the study consisted of the nursing students who had to be tetanus vaccinated as a protective measure. The students were divided into two groups, as the rapid injection technique without aspiration and control group. The Numerical Rating Scale was used to determine the perceived pain level

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Rapid Injection Group Without Aspiration; Other: Control

Detailed Description

Study Design; This was an experimental, single-blind, randomized controlled trial.

Study Population and Study Sample; The study was conducted in Turkey, in a family health center (FHC) in Central Anatolia Region. The population of the study consisted of the nursing students (n:125) of the faculty of health sciences who had to be tetanus-vaccinated as a protective measure before the clinical practice. Sample selection was not performed in the study and the whole population was tried to be reached. However, as 53 students were vaccinated before and 2 students used a painkiller before the vaccination, the sample of the study consisted of a total of 70 students.

The distributions of the students, who came to the family health center for the vaccination and were in accordance with the inclusion criteria, to the intervention group in which the rapid injection technique without aspiration was applied and the control group in which no intervention were applied by the simple randomized method. The papers with the same color and folding shape that represented the two study groups were put into a cloth bag. In order to provide the randomized distribution and reduce all the negative effects, the required explanation was made to the individuals to be vaccinated and they were requested to pull a paper randomly from the bag. In this way, the groups were balanced and totally 35 students were included in each group.

The personal information form was filled for each individual, who came to the FHC for the vaccination and agreed to participate in the study, before the procedure. The tetanus vaccine was applied into the deltoid muscle of the left arm in the sitting position in both the intervention and the control groups in the vaccination room. All the vaccines were made by a single researcher in order to eliminate the vaccination differences.

Outcome Measures Pain Level; As the study was a single-blind trial, the pain assessment was performed by another nurse, in the second minute after the injection, using the numerical pain rating scale, in order to provide neutrality. The nurse was informed by the researcher about the use of the scale. The nurses had no conflict of interest.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankiri, Turkey, 18200
    • Çankırı Karatekin Univesity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy students,
• who did not take any painkiller before the vaccination,
• agreed to participate in the study and gave verbal consent were included in the study.

Exclusion Criteria:

• the individuals with pain and/or acute pyretic disease,
• who underwent topical anesthesia and/or used any painkillers were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapid Injection Group Without Aspiration; The tetanus vaccine was applied into the deltoid muscle of the left arm in the sitting position by rapid injection technique without aspiration.	Other: Rapid Injection Group Without Aspiration; After filling in the personal information form, the tetanus vaccine was administered by using rapid injection without aspiration technique (the injector was held at 90 degrees, it was pricked into tissue rapidly, and the drug was given in 1-2 seconds without performing aspiration). (the injector was held at 90 degrees, it was pricked into tissue rapidly, and the drug was given in 1-2 seconds without performing aspiration). 2 days after the vaccination, the researcher got in contact with the students in the intervention and the control groups in order to ask whether a local side effect developed in the vaccination site or not.
Experimental: Control; The tetanus vaccine was applied into the deltoid muscle of the left arm in the sitting position with the standard injection technique.	Other: Control; After filling in the personal information form, the tetanus vaccine was made in accordance with the standard injection technique included in the application (the injector was held at 90 degrees, it was pricked into tissue, and the drug was given in 5-10 seconds after performing aspiration). 2 days after the vaccination, the researcher got in contact with the students in the intervention and the control groups in order to ask whether a local side effect developed in the vaccination site or not.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain severity	As the study was a single-blind trial, the pain assessment was performed by another nurse, in the second minute after the injection, using the numerical pain rating scale, in order to provide neutrality. The nurse was informed by the researcher about the use of the Numerical Pain Rating Scale (NPRS). NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes (Rodrigues, 2001; Hawker, 2011). The scale is composed of numbers between 0 and 10. The pain scoring is performed in the way that the individual chooses the closest point related to his/her pain. "0 point" signifies no pain and "10 points" signify worst pain.	2 MONTHS

Collaborators and Investigators

• Sponsor: Çankırı Karatekin University

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): August 15, 2018

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Aspiration; Vaccination; pain management
• Other Study ID Numbers: 2018/9 (Registry Identifier: Regional Ethical Review Board in Lund, Sweden)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No