IM InjectionNCT07157592
Effect of Ventrogluteal Intramuscular Injection Technique on Children
A study testing Ventrogluteal IM Injection tecnique in people with IM Injection and Ventrogluteal Site, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Intramuscular injection is one of the most frequently practiced basic nursing skills in emergency units. However, serious complications may develop when this skill is not applied with the correct technique. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- IM Injection, Ventrogluteal Site, Children
- What is being tested?
- Ventrogluteal IM Injection tecnique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 30 Dec 2023
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being 6-12 years old.
- Being willing to participate in the research.
- Not having a chronic disease or mental or neurological disability.
- Being able to communicate verbally.
Who cannot join
- Taking any analgesic medication within 6 hours before the application to the emergency department.
- Having a life-threatening disease (e.g., sepsis, shock, respiratory or cardiogenic arrest).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ventrogluteal Intramuscular Injection Technique on Pain and Physiological Parameters in Children: A Quasi-Experimental Study
Intramuscular injection is one of the most frequently practiced basic nursing skills in emergency units. However, serious complications may develop when this skill is not applied with the correct technique.
The aim of the study is to investigate the effect of ventrogluteal intramuscular injection technique on pain and physiological parameters in children.
Read more
The quasi-experimental study was conducted with 90 children aged 6-12 years. The data were obtained from two groups: the control group, in which routine care was applied during intramuscular injection, and the intervention group, in which the ventrogluteal intramuscular injection technique was applied. The pain and physiological parameters of children in both groups before and after the intervention were compared.
The mean pulse rate was lower in the intervention group compared to the control group after the procedure (p<0.05). When the mean pain scores after the procedure were analyzed, the scores in the intervention group were lower than in the control group (p<0.05). The use of ventrogluteal intramuscular injection technique during in children was effective in reducing pain levels and decreasing pulse rate. These findings support incorporating this technique into routine nursing practice to enhance comfort and safety during intramuscular injections in children.
- Conditions
- IM Injection, Ventrogluteal Site, Children, Pain
- Being tested
- Ventrogluteal IM Injection tecnique
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventrogluteal IM Injection tecniqueOther
Ventrogluteal IM injection technique:
During IM injection into the ventrogluteal region:
- The entrance angle of the needle is 90º.
- The 25-gauge (1-inch) syringe is held with the active hand as if holding a pen, and no hand change is made during the injection.
- The needle is rapidly inserted into the skin and withdrawn at the same angle 5 seconds after the injection.
- The drug is injected for 5 seconds/mL without blood aspiration during injection.
- Light pressure is applied to the area after injection, with no massage performed.
To evaluate the appropriateness of the application ventrogluteal IM injection technique, the opinions were obtained of five experts in nursing principles and child health and disease nursing.
| Study group | Role | What they receive |
|---|---|---|
| Ventrogluteal IM injection protocol | Experimental | Not described Receives: Other: Ventrogluteal IM Injection tecnique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Scale (Pain Face Rating Scale)
Faces represent increasing pain intensity from 0 to 5 from left to right. The leftmost face has a smiling expression indicating a pain-free state, whereas the face at the right end has a crying expression corresponding to the most severe pain. Below each face is a short description of the pain intensity: 0-no pain, 1-mild pain, 2-slightly more pain, 3-even more pain, 4-considerably more pain, and 5-most severe pain
Measured: Before and 5 minutes after the procedure
SpO2 and pulse rate
A calibrated pulse oximeter (Nellcor OxiMax N-65) was used to determine the oxygen saturation (SpO2) and pulse rate of the children before and after vaccine injection. The pulse oximeter shows the SpO2 and pulse rate on an LCD screen. It works with four AA batteries. The SpO2 and pulse rate were obtained by attaching the probe of the pulse oximeter to the thumb of the children.
Measured: Before and 5 minutes after the procedure
Blood pressure
A calibrated digital sphygmomanometer (Omron M3 Comfort) was used to determine the blood pressure of the children before and after IM injection. The sphygmomanometer shows systolic and diastolic blood pressure values on an LCD screen. A baby cuff was attached to the sphygmomanometer, and the systolic and diastolic blood pressure values were determined by attaching the cuff to the right arm of the children.
Measured: Before and 5 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start15 Sep 2023
- Primary completion15 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IM InjectionStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Terzi, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157592
- Sponsor's protocol ID
- 2023/06
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ventrogluteal Intramuscular Injection Technique on Pain and Physiological Parameters in Children: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07157592
- Acronym / sponsor ID
- 2023/06
- Conditions
- IM Injection, Ventrogluteal Site, Children, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 5 Sep 2025 (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.
Intramuscular injection is one of the most frequently practiced basic nursing skills in emergency units. However, serious complications may develop when this skill is not applied with the correct technique.
The aim of the study is to investigate the effect of ventrogluteal intramuscular injection technique on pain and physiological parameters in children.
The quasi-experimental study was conducted with 90 children aged 6-12 years. The data were obtained from two groups: the control group, in which routine care was applied during intramuscular injection, and the intervention group, in which the ventrogluteal intramuscular injection technique was applied. The pain and physiological parameters of children in both groups before and after the intervention were compared.
The mean pulse rate was lower in the intervention group compared to the control group after the procedure (p<0.05). When the mean pain scores after the procedure were analyzed, the scores in the intervention group were lower than in the control group (p<0.05). The use of ventrogluteal intramuscular injection technique during in children was effective in reducing pain levels and decreasing pulse rate. These findings support incorporating this technique into routine nursing practice to enhance comfort and safety during intramuscular injections in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventrogluteal IM injection protocol | Experimental | Other: Ventrogluteal IM Injection tecnique |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being 6-12 years old.
- Being willing to participate in the research.
- Not having a chronic disease or mental or neurological disability.
- Being able to communicate verbally.
Key exclusion criteria (2 listed)
- Taking any analgesic medication within 6 hours before the application to the emergency department.
- Having a life-threatening disease (e.g., sepsis, shock, respiratory or cardiogenic arrest).
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 |
|---|---|---|
| Ventrogluteal IM Injection tecniqueVentrogluteal IM injection technique: During IM injection into the ventrogluteal region: * The entrance angle of the needle is 90º. * The 25-gauge (1-inch) syringe is held with the active hand as if holding a pen, and no hand change is made during the injection. * The needle is rapidly inserted into the skin and withdrawn at the same angle 5 seconds after the injection. * The drug is injected for 5 seconds/mL without blood aspiration during injection. * Light pressure is applied to the area after injection, with no massage performed. To evaluate the appropriateness of the application ventrogluteal IM injection technique, the opinions were obtained of five experts in nursing principles and child health and disease nursing. | Other | Ventrogluteal IM injection protocol |
Primary outcome
Wong-Baker Scale (Pain Face Rating Scale)
Time frame: Before and 5 minutes after the procedure
Faces represent increasing pain intensity from 0 to 5 from left to right. The leftmost face has a smiling expression indicating a pain-free state, whereas the face at the right end has a crying expression corresponding to the most severe pain. Below each face is a short description of the pain intensity: 0-no pain, 1-mild pain, 2-slightly more pain, 3-even more pain, 4-considerably more pain, and 5-most severe pain
SpO2 and pulse rate
Time frame: Before and 5 minutes after the procedure
A calibrated pulse oximeter (Nellcor OxiMax N-65) was used to determine the oxygen saturation (SpO2) and pulse rate of the children before and after vaccine injection. The pulse oximeter shows the SpO2 and pulse rate on an LCD screen. It works with four AA batteries. The SpO2 and pulse rate were obtained by attaching the probe of the pulse oximeter to the thumb of the children.
Blood pressure
Time frame: Before and 5 minutes after the procedure
A calibrated digital sphygmomanometer (Omron M3 Comfort) was used to determine the blood pressure of the children before and after IM injection. The sphygmomanometer shows systolic and diastolic blood pressure values on an LCD screen. A baby cuff was attached to the sphygmomanometer, and the systolic and diastolic blood pressure values were determined by attaching the cuff to the right arm of the children.
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 5 Sep 2025.
- 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 Ventrogluteal IM Injection tecnique in people with IM Injection and Ventrogluteal Site, run by Akdeniz 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 4 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 5 Sep 2025. 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?
Wong-Baker Scale (Pain Face Rating Scale) (time frame: Before and 5 minutes after the procedure). The study lists 3 primary outcomes in all. 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 5 Sep 2025.