NCT07157592

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 28, 2025

Last Update Submit

August 28, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

    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.

    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.

    Before and 5 minutes after the procedure

Study Arms (1)

Ventrogluteal IM injection protocol

EXPERIMENTAL
Other: Ventrogluteal IM Injection tecnique

Interventions

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.

Ventrogluteal IM injection protocol

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Banu Terzi, PhD, RN, Associate Professor

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 5, 2025

Study Start

September 15, 2023

Primary Completion

December 15, 2023

Study Completion

December 30, 2023

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations