NCT07418697

Brief Summary

Intramuscular (IM) injection is a fundamental nursing skill that requires accurate anatomical knowledge, correct technique, and safe practice. The ventrogluteal site is currently recommended in clinical guidelines as the safest area for IM injections because it is far from major nerves and blood vessels and allows effective medication absorption. However, identifying the correct anatomical landmarks and performing the procedure accurately can be challenging for nursing students, particularly during early skills training. Different teaching approaches are used in nursing education to support the acquisition of psychomotor skills. The traditional Halsted approach ("see one, do one") is widely used because it is time-efficient, but it may not provide sufficient structure for learning complex, multi-step procedures. In contrast, Peyton's four-step teaching approach offers a structured and interactive method that includes demonstration, explanation, learner-guided repetition, and independent performance. This approach is designed to enhance understanding, skill retention, and active participation in the learning process. The aim of this randomized controlled trial is to compare the effects of the Halsted teaching approach and Peyton's four-step teaching approach on nursing students' knowledge, skill performance, and self-regulated learning related to ventrogluteal injection administration. The study is conducted with first-year nursing students enrolled in the Fundamentals of Nursing course at a university in Türkiye during the 2025-2026 academic year. A total of 120 nursing students are randomly assigned to either the intervention group or the control group. All students receive the same theoretical instruction and access to standardized instructional videos before laboratory practice. The control group is taught ventrogluteal injection using the traditional Halsted approach, while the intervention group receives training based on Peyton's four-step teaching method. Skill performance is assessed using an objective structured clinical examination (OSCE) with a standardized skill checklist. Knowledge levels are measured using a validated multiple-choice test, and self-regulated learning is evaluated using a reliable and validated self-regulated learning scale for clinical nursing practice. The results of this study are expected to provide evidence on whether a structured teaching approach improves learning outcomes in nursing skills education. Findings may contribute to the development of more effective educational strategies for teaching high-risk and technically demanding nursing procedures, ultimately supporting patient safety and clinical competence in future nurses.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

February 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

28 days

First QC Date

February 9, 2026

Last Update Submit

February 14, 2026

Conditions

Keywords

nursşng educationVentrogluteal injectionIntramuscular injectionPsychomotor skill trainingPeyton four-step approachSelf-regulated learning

Outcome Measures

Primary Outcomes (1)

  • Ventrogluteal Injection Skill Performance

    Skill performance in ventrogluteal intramuscular injection administration is assessed using a structured Ventrogluteal Injection Skill Checklist during an Objective Structured Clinical Examination (OSCE). The checklist consists of 33 items evaluating correct performance of each procedural step. Each item is scored as 0 (incorrect/not performed) or 1 (correct), and total scores are converted to a 0-100 scale. Higher scores indicate better skill performance.

    Immediately after completion of the laboratory training session

Study Arms (2)

Peyton Four-Step Teaching Approach

EXPERIMENTAL

Participants in this arm receive training in ventrogluteal intramuscular injection using Peyton's four-step teaching approach, including demonstration, explanation, learner-guided demonstration, and independent performance during laboratory practice.

Behavioral: Peyton Four-Step Teaching Approach

Halsted Teaching Method

ACTIVE COMPARATOR

Participants in this arm receive training in ventrogluteal intramuscular injection using the traditional Halsted teaching method ("see one, do one") during laboratory practice.

Behavioral: Halsted Teaching Method

Interventions

A structured educational intervention based on Peyton's four-step teaching approach, including silent demonstration, demonstration with explanation, learner-guided demonstration, and independent performance of ventrogluteal intramuscular injection in a laboratory setting.

Peyton Four-Step Teaching Approach

A traditional educational intervention based on the Halsted teaching method ("see one, do one"), in which students observe the ventrogluteal intramuscular injection procedure and then perform it individually during laboratory practice.

Halsted Teaching Method

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • First-year undergraduate nursing students
  • Enrolled in the Fundamentals of Nursing course for the first time
  • Have viewed the online instructional videos related to ventrogluteal intramuscular injection before laboratory practice
  • Agree to participate voluntarily
  • Provide written informed consent
  • Attend all scheduled theoretical and laboratory training sessions

You may not qualify if:

  • Graduated from a health vocational high school
  • Previously received formal education or training on intramuscular injection techniques
  • Do not attend theoretical or laboratory sessions related to the study
  • Do not complete the data collection tools
  • Withdraw from the study at any stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Gözde ÖZARAS ÖZ, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study uses a parallel-group randomized controlled design. Eligible nursing students are randomly assigned to either an intervention group receiving training based on Peyton's four-step teaching approach or a control group receiving training based on the traditional Halsted teaching method. Both groups receive the same theoretical instruction prior to laboratory practice, and outcomes are assessed after the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Nursing

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 18, 2026

Study Start

February 1, 2026

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

This study is an educational intervention conducted with undergraduate nursing students. Individual participant data will not be shared because the data consist of educational assessments, skill performance scores, and self-reported learning measures collected within an institutional training context. Data sharing was not included in the informed consent process, and sharing individual-level data could compromise participant confidentiality.