Comparison of Intramuscular Injection From Two Different Sites in Children

NCT ID: NCT05279144

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-25
• Study Completion Date: 2022-07-30

Brief 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. 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.

Conditions

Application Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ventroguleal

Intervention Type: OTHER

Vastus Lateralis

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ventroguleal

Vastus Lateralis

Intervention Type: OTHER

Other Intervention Names

Control

Eligibility Criteria

Inclusion Criteria

• 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,
• 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.

Exclusion Criteria

• - 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

öznur tiryaki

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

DİLEK MENEKŞE, Assis prof.

Role: STUDY_DIRECTOR

Sakarya University

NURSAN ÇINAR, Proffesor

Role: PRINCIPAL_INVESTIGATOR

Sakarya University

BAHRİ ELMAS, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Sakarya University

ÖNER ÖZDEMİR, Proffesor

Role: PRINCIPAL_INVESTIGATOR

Sakarya University

Locations

Sakarya Education and Training Hospital

Sakarya, Adapazarı, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ÖZNUR TİRYAKİ

Identifier Type: -

Identifier Source: org_study_id