NCT05952323

Brief Summary

A significant portion of nursing practice involves the application of technical skills and the use of medical devices. Nowadays, the number and complexity of medical devices in healthcare settings are increasing. Therefore, it is of great importance for nurses to have appropriate knowledge and skills in this field to provide adequate and safe patient care.

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 Nov 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

First Submitted

Initial submission to the registry

July 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

July 11, 2023

Last Update Submit

November 12, 2024

Conditions

Keywords

CompetencyMedical devicesNursingTeach-BackStudentsVideo-assisted teaching

Outcome Measures

Primary Outcomes (3)

  • The Medical Device Usage Competency Self-Assessment Form

    The Medical Device Usage Competency Self-Assessment Form is a tool used to assess an individual's self-perceived competency in using medical devices. It typically consists of a series of questions or statements related to different aspects of medical device usage, such as knowledge, skills, and confidence. A research form has been developed by the researcher through a literature review. The content validity of the form will be determined and Cronbach's Alpha coefficient will be examined. The form is designed using a five-point Likert scale to capture participants' opinions on medical device usage competency.

    6 months

  • The Medical Device Usage Competency Knowledge Test

    It typically consists of a series of questions or scenarios related to different aspects of medical devices, including their purpose, indications, proper usage techniques, safety precautions, troubleshooting, and maintenance. The test aims to evaluate the individual's factual knowledge and comprehension of essential information related to medical device usage. Knowledge Test has been developed by the researcher based on the literature review. Expert opinions will be sought to validate the content of the test. The test will consist of multiple-choice and true/false questions.

    6 months

  • The Medical Device Usage Competency Observer Evaluation Form

    It is typically completed by trained observers or evaluators who assess the individual's performance in using medical devices based on specific criteria. The form serves as a standardized assessment tool to gather objective data on the individual's practical skills and abilities in handling medical devices. The form has been developed by the researcher based on the available literature. The content validity of the steps in the form will be determined based on expert opinions.

    6 months

Study Arms (3)

Control group

NO INTERVENTION

After obtaining the necessary legal and ethical permissions for data collection, the research will commence. During this stage of the study, participants who agree to take part in the research will be asked to fill out the informed consent form. To obtain the pre-test data for the research, all forms will be filled out. Students receiving standard care and continuing practice will be provided with information about the research. Pre-test and post-test data from the control group will be obtained concurrently with the study groups.

Teach-back group

EXPERIMENTAL

To obtain the pre-test data for the research, all forms will be filled out. According to the prepared educational materials for medical devices, students will be trained using the teach-back method. After the training, students will be asked to demonstrate their skills in using medical devices then two weeks after the pre-test. The researcher will use the Medical Device Usage Competency Observer Evaluation Form to assess the student's competency in using medical devices and Medical Device Usage Competency Knowledge Test and the Medical Device Usage Competency Self-Assessment Form for post-test data.

Other: Teach-back

Video-assisted teaching group

EXPERIMENTAL

After obtaining the pre-test data, students will be sent educational videos related to medical devices and asked to watch them. Then two weeks after sending the videos, students will be requested to demonstrate their skills in using medical devices. The researcher will assess the students' medical device usage competencies using the Medical Device Usage Competency Observer Evaluation Form, Medical Device Usage Competency Knowledge Test, and the Medical Device Usage Competency Self-Assessment Form for post-test data.

Other: Video-assisted teaching

Interventions

According to the prepared educational materials for medical devices, students will be trained using the teach-back method.

Teach-back group

Students will be sent educational videos related to medical devices and asked to watch them.

Video-assisted teaching group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be a senior nursing student
  • Be taking the Nursing Care Management course for the first time
  • Have no previous work experience as a nurse outside of clinical training
  • Have no visual, auditory, cognitive, or perceptual impairments
  • Not have received any planned training program or course specifically on the use of infusion pumps, patient monitors, and suction devices
  • Have access to an Android phone or computer for the study.

You may not qualify if:

  • Have graduated from a Health Vocational High School.
  • Be taking the Nursing Care Management course for the second time.
  • Obtain a score above the predetermined threshold on the knowledge test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turgut Ozal Medical Center

Malatya, 44000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: A two-tailed test at a 5% significance level with a power of 95% indicated that a sample size of 90 was required for an effect size of 0.37. Considering potential data loss during the research process, 5 students will included in each group (teach-back group = 35, video-assisted teaching group = 35, control group = 35). Since it is anticipated that student performance may affect competency, students will be stratified based on their overall academic average in this study. Subsequently, computer-assisted randomization will be used to assign an equal number of students from each stratum to each group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 19, 2023

Study Start

November 15, 2023

Primary Completion

February 25, 2024

Study Completion

August 15, 2024

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

This research is a doctoral thesis study. The research is expected to be completed.

Locations