Clinical trial NCT03723421: Rapid Injection Technique Without Aspiration
Official title: The Effect of the Rapid Injection Technique Without Aspiration on Pain Level in Intramuscular Vaccination- A Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain management
Vaccination
Aspiration
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain severity
timeFrame: 2 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Çankiri
country: Turkey
facility: Çankırı Karatekin Univesity
Study officials:
References: