Rapid Injection Technique Without Aspiration

NCT03723421 | Completed

• 1 other identifier: 2018/9
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

pain management; Vaccination; Aspiration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Rapid Injection Group Without Aspiration

EXPERIMENTAL

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

Control

EXPERIMENTAL

The tetanus vaccine was applied into the deltoid muscle of the left arm in the sitting position with the standard injection technique.

Other: Control

Interventions

Rapid Injection Group Without Aspiration OTHER

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.

Rapid Injection Group Without Aspiration

Control OTHER

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.

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

Çankırı Karatekin Univesity

Çankiri, 18200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD RN, Asistant PROFESSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 29, 2018
• Study Start: March 28, 2018
• Primary Completion: May 30, 2018
• Study Completion: August 15, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-10

Locations

TU (1)