NursingNCT04421599
Necessity of Aspiration in the Ventrogluteal Site
A study testing The Necessity of Aspiration in people with Nursing and Injection Site, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
H1: Aspiration is not necessary for IM injections applied from the ventrogluteal region. H2: Aspiration procedure increases pain in IM injections applied from ventrogluteal region. H3: The duration of the aspiration procedure on IM injections applied from the ventrogluteal region is effective on pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing, Injection Site
- What is being tested?
- The Necessity of Aspiration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 834 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jan 2019to 20 Jun 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient who came to the Emergency Service Care Unit for "Diclofenac Sodium" injection
- Have no vision and hearing problems,
- Who have no disease that may affect their perception of pain
- Who can evaluate the "Visual Analog Scale" correctly, scoring 5 points or less from the VAS,
- Body Mass Index is between 18.5-24.9 kg / m2,
- Who do not have any discomfort in the extremities that will prevent them from taking the desired position,
- No complications due to intramuscular injections such as abscess, infection, tissue necrosis and hematoma in the ventrogluteal region
- No nodules or masses in the area
Who cannot join
- Patients who refuse the injection are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Necessity of Aspiration During The Intramuscular Injection Administered in the Ventrogluteal Site and Its Effect on Pain
H1: Aspiration is not necessary for IM injections applied from the ventrogluteal region.
H2: Aspiration procedure increases pain in IM injections applied from ventrogluteal region.
H3: The duration of the aspiration procedure on IM injections applied from the ventrogluteal region is effective on pain.
- Conditions
- Nursing, Injection Site
- Being tested
- The Necessity of Aspiration
- Keywords
- Ventrogluteal area, aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Necessity of AspirationOther
The patients who met the inclusion criteria and agreed to participate in the study were assigned to the Experimental Group A who were administered IM injection during which aspiration lasted for 5-10 seconds, to the Control Group who were administered IM injection during which aspiration lasted for 1-2 seconds, and to the Experimental Group B who were not administered IM injection according to the stratified block randomization list. The same "Intramuscular Injection Application Protocol" was applied while all the injections were administered.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group A | Experimental | Experimental Group A who were administered intramuscular injection during which aspiration lasted for 5-10 seconds. Receives: Other: The Necessity of Aspiration |
| Control Group | No intervention | Control Group who were administered intramuscular injection during which aspiration lasted for 1-2 seconds. |
| Experimental Group B | Experimental | Experimental Group B who were not administered aspiration during IM injection. Receives: Other: The Necessity of Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual Introductory Information Form
The content of the study was explained to the patients coming to the emergency room. Written informed consents were obtained in line with the "Individual Introductory Information Form" of the patients.
Individual Introductory Information Form: This form includes questions such as the patient's application group, diagnosis, age, gender, height, weight, and blood intake during aspiration in intramuscular injection. It is completed within the first 10-15 minutes of contact with the patient.
Measured: 15 minutes
Visual Analog Scale (VAS)
Intramuscular injection was performed in accordance with the application group assigned to the patients who filled the Individual Introductory Information Form. The patients were not told which group they belonged to.
A nurse who except the researcher who performed the application evaluated pain levels that patients feel during injection immediately after the intramuscular injection application, with a Visual Analog Scale. The minimum score that can be obtained from this scale is 0 and the maximum score is 10. A higher score indicates that the pain is more severe. This scale was applied in minutes 1-5 after intramuscular injection.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start14 Jan 2019
- Primary completion10 Jun 2020 (estimated)
- Study completion20 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NursingStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 834 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla BARAN, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421599
- Sponsor's protocol ID
- 0000-0001-7881-8556
- Status last verified
- Jun 2020
- First submitted
- 4 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beyea SC, Nicoll LH. Administration of medications via the intramuscular route: an integrative review of the literature and research-based protocol for the procedure. Appl Nurs Res. 1995 Feb;8(1):23-33. doi: 10.1016/s0897-1897(95)80279-7.
PubMed 7695353Baran L, Gunes U, Donmez H. Investigation of the Necessity of Aspiration During the Intramuscular Injection Administered in the Ventrogluteal Site and Its Effect on Pain: A Randomized Controlled Trial. Clin Nurs Res. 2023 May;32(4):821-829. doi: 10.1177/10547738221136470. Epub 2022 Dec 20.
PubMed 36540016
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Necessity of Aspiration During The Intramuscular Injection Administered in the Ventrogluteal Site and Its Effect on Pain
- ClinicalTrials.gov ID
- NCT04421599
- Acronym / sponsor ID
- 0000-0001-7881-8556
- Conditions
- Nursing, Injection Site
- Keywords
- Ventrogluteal area, aspiration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 834 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 10 Jun 2020 (estimated)
- Study completion
- 20 Jun 2020 (estimated)
- First posted
- 9 Jun 2020 (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.
H1: Aspiration is not necessary for IM injections applied from the ventrogluteal region.
H2: Aspiration procedure increases pain in IM injections applied from ventrogluteal region.
H3: The duration of the aspiration procedure on IM injections applied from the ventrogluteal region is effective on pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A | Experimental | Other: The Necessity of AspirationExperimental Group A who were administered intramuscular injection during which aspiration lasted for 5-10 seconds. |
| Control Group | No intervention | –Control Group who were administered intramuscular injection during which aspiration lasted for 1-2 seconds. |
| Experimental Group B | Experimental | Other: The Necessity of AspirationExperimental Group B who were not administered aspiration during IM injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient who came to the Emergency Service Care Unit for "Diclofenac Sodium" injection
- Have no vision and hearing problems,
- Who have no disease that may affect their perception of pain
- Who can evaluate the "Visual Analog Scale" correctly, scoring 5 points or less from the VAS,
- Body Mass Index is between 18.5-24.9 kg / m2,
Key exclusion criteria (1 listed)
- Patients who refuse the injection are excluded.
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 |
|---|---|---|
| The Necessity of AspirationThe patients who met the inclusion criteria and agreed to participate in the study were assigned to the Experimental Group A who were administered IM injection during which aspiration lasted for 5-10 seconds, to the Control Group who were administered IM injection during which aspiration lasted for 1-2 seconds, and to the Experimental Group B who were not administered IM injection according to the stratified block randomization list. The same "Intramuscular Injection Application Protocol" was applied while all the injections were administered. | Other | Experimental Group A, Experimental Group B |
Primary outcome
Individual Introductory Information Form
Time frame: 15 minutes
The content of the study was explained to the patients coming to the emergency room. Written informed consents were obtained in line with the "Individual Introductory Information Form" of the patients. Individual Introductory Information Form: This form includes questions such as the patient's application group, diagnosis, age, gender, height, weight, and blood intake during aspiration in intramuscular injection. It is completed within the first 10-15 minutes of contact with the patient.
Visual Analog Scale (VAS)
Time frame: 5 minutes
Intramuscular injection was performed in accordance with the application group assigned to the patients who filled the Individual Introductory Information Form. The patients were not told which group they belonged to. A nurse who except the researcher who performed the application evaluated pain levels that patients feel during injection immediately after the intramuscular injection application, with a Visual Analog Scale. The minimum score that can be obtained from this scale is 0 and the maximum score is 10. A higher score indicates that the pain is more severe. This scale was applied in minutes 1-5 after intramuscular injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Background: PubMed 7695353Beyea SC, Nicoll LH. Administration of medications via the intramuscular route: an integrative review of the literature and research-based protocol for the procedure. Appl Nurs Res. 1995 Feb;8(1):23-33. doi: 10.1016/s0897-1897(95)80279-7.
- Derived from this study: PubMed 36540016Baran L, Gunes U, Donmez H. Investigation of the Necessity of Aspiration During the Intramuscular Injection Administered in the Ventrogluteal Site and Its Effect on Pain: A Randomized Controlled Trial. Clin Nurs Res. 2023 May;32(4):821-829. doi: 10.1177/10547738221136470. Epub 2022 Dec 20.
- Individual participant dataSharing planned: No
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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 The Necessity of Aspiration in people with Nursing and Injection Site, run by Ege 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 8 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. 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?
Results are not available in the source record.
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?
Individual Introductory Information Form (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04421599, which also lists 2 linked publications.
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 11 Jun 2020.