PainNCT03723421
Rapid Injection Technique Without Aspiration
A study testing Rapid Injection Group Without Aspiration in people with Pain, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Rapid Injection Group Without Aspiration
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Mar 2018to 15 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- the individuals with pain and/or acute pyretic disease,
- who underwent topical anesthesia and/or used any painkillers were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Pain
- Being tested
- Rapid Injection Group Without Aspiration, Control
- Keywords
- pain management, Vaccination, Aspiration
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Injection Group Without AspirationOther
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start28 Mar 2018
- Primary completion30 May 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İLKNUR GÖL, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723421
- Sponsor's protocol ID
- 2018/9
- Status last verified
- Oct 2018
- First submitted
- 26 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Rapid Injection Technique Without Aspiration on Pain Level in Intramuscular Vaccination- A Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03723421
- Acronym / sponsor ID
- 2018/9
- Conditions
- Pain
- Keywords
- pain management, Vaccination, Aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid Injection Group Without Aspiration | Experimental | Other: Rapid Injection Group Without AspirationThe tetanus vaccine was applied into the deltoid muscle of the left arm in the sitting position by rapid injection technique without aspiration. |
| Control | Experimental | Other: ControlThe tetanus vaccine was applied into the deltoid muscle of the left arm in the sitting position with the standard injection technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- the individuals with pain and/or acute pyretic disease,
- who underwent topical anesthesia and/or used any painkillers were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Injection Group Without AspirationAfter 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. | Other | Rapid Injection Group Without Aspiration |
| ControlAfter 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. | Other | Control |
Primary outcome
Pain severity
Time frame: 2 MONTHS
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Injection Group Without Aspiration in people with Pain, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity (time frame: 2 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.