Application Site InfectionInjectionNCT05279144
Comparison of Intramuscular Injection From Two Different Sites in Children
A study testing Ventroguleal in people with Application Site Infection, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Administration of intramuscular injections (IM) is now common practice in pediatric clinical settings. For this reason, nurses should both update their clinical skills and provide evidence-based practices to children. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Application Site Infection
- What is being tested?
- Ventroguleal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2022to 30 Jul 2022
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being in the age group of 4-6
- Ordering Prendol amp IM by the doctor,
- IM application in pediatric emergency,
- Absence of a disease that causes chronic pain,
- Absence of a neurodevelopmental disorder,
- Not taking analgesics in the last 6 hours,
Show all 11Show fewer
- No history of fainting during the injection,
- Absence of mental retardation,
- Absence of scar tissue or muscle atrophy in the area to be injected,
- Being in the 10th to 90th percentile
- Families and children agree to participate in the research.
Who cannot join
- - being less than 4 years old,
- Over 6 years of age,
- Scar or muscle atrophy at the injection site,
- The child or parent has communication problems,
- The percentile is below 10 (cachectic) or over 90 (obese),
- Families and children do not agree to participate in the research.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya Education and Training Hospital
Sakarya, Adapazarı, 54050
About this study
Official title: Comparison of Intramuscular Injection From Two Different Sites in Children Pain and Fear: A Randomized Controlled Study
Administration of intramuscular injections (IM) is now common practice in pediatric clinical settings. For this reason, nurses should both update their clinical skills and provide evidence-based practices to children. The aim of this study; The aim of this study is to compare vastus lateralis (VL) and ventrogluteal (VG) region applications in terms of pain and fear in safe and evidence-based intramuscular injection application in children.
H0: There is no difference in terms of pain and fear between the children aged 4-6 years who received IM from the vastus lateralis (VL) region and those who received IM from the ventrogluteal (VG) region.
Read more
H1: Children between the ages of 4 and 6 years IM administered from the vastus lateralis (VL) region have higher pain than those administered IM from the ventrogluteal (VG) region.
H2: The fear of children aged 4-6 years who underwent IM from the vastus lateralis (VL) region is higher than that of children who were administered IM from the Ventrogluteal (VG) region.
Read the detailed description
Intramuscular injection (IMI) is widely used in the pediatric emergency department and is a cause of pain for children. The aim of this study is to compare the vastus lateralis (VL) and ventrogluteal (VG) region applications in terms of pain and fear in intramuscular injection application in children aged 4-6 years.
The population of the study consists of children aged 4-6 years who applied to the emergency department for IM injection. The sample of the study consisted of 80 children (40 in the intervention group, 40 in the control group) who met the inclusion criteria within the specified date range.
The injection technique was explained to the parents and children by showing the location of the VL and VG regions on the model doll. Both parents and their children were informed about the research. Written and verbal consent was obtained from the parents and verbal consent was obtained from the children. It was decided to meet the control group for one week and the intervention group for one week in order to avoid any interference between the two groups. In which week the children will be included in which group was randomly determined in the computer environment. There are two stretchers and a privacy curtain between them in the injection room in the Pediatric Emergency Clinic where the research was conducted. The nurse in charge of the daily injection room changes. For each patient who comes for injection, the ordered prescription is checked first, and then it is entered into the hospital system. The ordered drug is based on 10 correct drug administration principles (1. Correct drug, 2. Correct dose, 3. Correct patient, 4. Correct time, 5. Correct route of administration, 6. Correct patient education, 7. Correct registration, 8. Confirmation of rejection. , 9. Correct drug preparation (form), 10. Correct answer). In order to determine whether a drug-related reaction has developed or not, the patient is observed until 15-30 minutes after the application (the time varies according to the drug). In the clinic, IM injection to children aged 4-6 years is routinely performed by nurses from the VL region.
Data collection instruments Questionnaire form, Wong-baker faces pain rating scale (WBFPTS), Children's Fear Scale (CFS) were used in the study.
- Conditions
- Application Site Infection
- Being tested
- Ventroguleal
- Keywords
- children, fear, pain, Intramuscular injection, injection site
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentrogulealOther
Also called Control
Vastus Lateralis
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Ventrogluteal region IM injection will be applied to the children in the intervention group, which is recommended by the literatureIn order to ensure that the children in the groups are similar in terms of two factors (same drug, same nurse) in the assignment, they will be assigned to the groups first by stratified sampling method and then by simple random sampling (http://www1.assumption.edu/users/avadum/applets/RandAssin/Groupgen). .html). In the case of a 5% margin of error and an effect width of 0.70 at 80% power, the total number of patients, including 40 control and 40 intervention groups, who met the inclusion criteria of the study, was determined as 80. Receives: Other: Ventroguleal |
| No Intervention | No intervention | Vastus Lateralis IM injection, which is the routine practice of the clinic, will be applied to the children in the control group of the study. In order to ensure that the children in the groups are similar in terms of two factors (same drug, same nurse) in the assignment, they will be assigned to the groups first by stratified sampling method and then by simple random sampling (http://www1.assumption.edu/users/avadum/applets/RandAssin/Groupgen). .html). In the case of a 5% margin of error and an effect width of 0.70 at 80% power, the total number of patients, including 40 control and 40 intervention groups, who met the inclusion criteria of the study, was determined as 80. |
What is being measured
The primary outcome is the main question the study is designed to answer.
children pain
Comparison of VL and VG injection application in terms of pain in children aged 4-6 years.
Wong-baker faces pain rating scale (Wong-baker) It can be applied between the ages of 3-18. It can be applied in many pains such as acute, chronic and postoperative pain. It was developed by Wong and Baker. The horizontal plane also contains six hand-drawn facial expressions. It is scored between 0-10 points. It symbolizes the phrase "no pain" with a smiley face on the far left. Pain increases from sodan to right. On the far right, there is a crying facial expression with tears representing the expression "unbearable pain".
Measured: through study completion, an average of 3month
fear
Comparison of VL and VG injection application in terms of fear in children aged 4-6 years.
Children's Fear Scale CFS is used to scale the child's anxiety level. The CDS is a scale from 0-4, consisting of showing five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety).
Measured: through study completion, an average of 3month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start25 Mar 2022
- Primary completion30 May 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Application Site InfectionStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of vastus lateralis (VL) and ventrogluteal (VG) region applications in terms of pain and fear in safe and evidence-based intramuscular injection application in children.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, öznur tiryaki, Sakarya University
- Investigators
- DİLEK MENEKŞE, Assis prof., Study director, Sakarya UniversityNURSAN ÇINAR, Proffesor, Principal investigator, Sakarya UniversityBAHRİ ELMAS, Assoc Prof, Principal investigator, Sakarya UniversityÖNER ÖZDEMİR, Proffesor, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279144
- Sponsor's protocol ID
- ÖZNUR TİRYAKİ
- Acronym
- Injection
- Status last verified
- May 2023
- First submitted
- 2 Feb 2022
- Last updated
- 16 May 2023
- Results posted
- 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 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intramuscular Injection From Two Different Sites in Children Pain and Fear: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05279144
- Acronym / sponsor ID
- Injection / ÖZNUR TİRYAKİ
- Conditions
- Application Site Infection
- Keywords
- children, fear, pain, Intramuscular injection, injection site
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 15 Mar 2022 (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.
Administration of intramuscular injections (IM) is now common practice in pediatric clinical settings. For this reason, nurses should both update their clinical skills and provide evidence-based practices to children. The aim of this study; The aim of this study is to compare vastus lateralis (VL) and ventrogluteal (VG) region applications in terms of pain and fear in safe and evidence-based intramuscular injection application in children.
H0: There is no difference in terms of pain and fear between the children aged 4-6 years who received IM from the vastus lateralis (VL) region and those who received IM from the ventrogluteal (VG) region.
H1: Children between the ages of 4 and 6 years IM administered from the vastus lateralis (VL) region have higher pain than those administered IM from the ventrogluteal (VG) region.
H2: The fear of children aged 4-6 years who underwent IM from the vastus lateralis (VL) region is higher than that of children who were administered IM from the Ventrogluteal (VG) region.
Detailed description
Intramuscular injection (IMI) is widely used in the pediatric emergency department and is a cause of pain for children. The aim of this study is to compare the vastus lateralis (VL) and ventrogluteal (VG) region applications in terms of pain and fear in intramuscular injection application in children aged 4-6 years.
The population of the study consists of children aged 4-6 years who applied to the emergency department for IM injection. The sample of the study consisted of 80 children (40 in the intervention group, 40 in the control group) who met the inclusion criteria within the specified date range.
The injection technique was explained to the parents and children by showing the location of the VL and VG regions on the model doll. Both parents and their children were informed about the research. Written and verbal consent was obtained from the parents and verbal consent was obtained from the children. It was decided to meet the control group for one week and the intervention group for one week in order to avoid any interference between the two groups. In which week the children will be included in which group was randomly determined in the computer environment. There are two stretchers and a privacy curtain between them in the injection room in the Pediatric Emergency Clinic where the research was conducted. The nurse in charge of the daily injection room changes. For each patient who comes for injection, the ordered prescription is checked first, and then it is entered into the hospital system. The ordered drug is based on 10 correct drug administration principles (1. Correct drug, 2. Correct dose, 3. Correct patient, 4. Correct time, 5. Correct route of administration, 6. Correct patient education, 7. Correct registration, 8. Confirmation of rejection. , 9. Correct drug preparation (form), 10. Correct answer). In order to determine whether a drug-related reaction has developed or not, the patient is observed until 15-30 minutes after the application (the time varies according to the drug). In the clinic, IM injection to children aged 4-6 years is routinely performed by nurses from the VL region.
Data collection instruments Questionnaire form, Wong-baker faces pain rating scale (WBFPTS), Children's Fear Scale (CFS) were used in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of vastus lateralis (VL) and ventrogluteal (VG) region applications in terms of pain and fear in safe and evidence-based intramuscular injection application in children.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: VentrogulealVentrogluteal region IM injection will be applied to the children in the intervention group, which is recommended by the literatureIn order to ensure that the children in the groups are similar in terms of two factors (same drug, same nurse) in the assignment, they will be assigned to the groups first by stratified sampling method and then by simple random sampling (http://www1.assumption.edu/users/avadum/applets/RandAssin/Groupgen). .html). In the case of a 5% margin of error and an effect width of 0.70 at 80% power, the total number of patients, including 40 control and 40 intervention groups, who met the inclusion criteria of the study, was determined as 80. |
| No Intervention | No intervention | –Vastus Lateralis IM injection, which is the routine practice of the clinic, will be applied to the children in the control group of the study. In order to ensure that the children in the groups are similar in terms of two factors (same drug, same nurse) in the assignment, they will be assigned to the groups first by stratified sampling method and then by simple random sampling (http://www1.assumption.edu/users/avadum/applets/RandAssin/Groupgen). .html). In the case of a 5% margin of error and an effect width of 0.70 at 80% power, the total number of patients, including 40 control and 40 intervention groups, who met the inclusion criteria of the study, was determined as 80. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Being in the age group of 4-6
- Ordering Prendol amp IM by the doctor,
- IM application in pediatric emergency,
- Absence of a disease that causes chronic pain,
- Absence of a neurodevelopmental disorder,
Key exclusion criteria (6 listed)
- - being less than 4 years old,
- Over 6 years of age,
- Scar or muscle atrophy at the injection site,
- The child or parent has communication problems,
- The percentile is below 10 (cachectic) or over 90 (obese),
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 |
|---|---|---|
| VentrogulealAlso: ControlVastus Lateralis | Other | Experimental |
Primary outcome
children pain
Time frame: through study completion, an average of 3month
Comparison of VL and VG injection application in terms of pain in children aged 4-6 years. Wong-baker faces pain rating scale (Wong-baker) It can be applied between the ages of 3-18. It can be applied in many pains such as acute, chronic and postoperative pain. It was developed by Wong and Baker. The horizontal plane also contains six hand-drawn facial expressions. It is scored between 0-10 points. It symbolizes the phrase "no pain" with a smiley face on the far left. Pain increases from sodan to right. On the far right, there is a crying facial expression with tears representing the expression "unbearable pain".
fear
Time frame: through study completion, an average of 3month
Comparison of VL and VG injection application in terms of fear in children aged 4-6 years. Children's Fear Scale CFS is used to scale the child's anxiety level. The CDS is a scale from 0-4, consisting of showing five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety).
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 16 May 2023.
- 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.
DİLEK MENEKŞE, Assis prof. study director
Sakarya University
NURSAN ÇINAR, Proffesor principal investigator
Sakarya University
BAHRİ ELMAS, Assoc Prof principal investigator
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventroguleal in people with Application Site Infection, run by Sakarya 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 11 inclusion and 6 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 16 May 2023. 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?
children pain (time frame: through study completion, an average of 3month). 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?
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 16 May 2023.