Nurse's RoleNCT05952323
Comparison of Different Teaching Methods in Increasing Nursing Students' Competencies for Safe Use of Medical Devices
A study testing Teach-back and Video-assisted teaching in people with Nurse's Role, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nurse's Role
- What is being tested?
- Teach-back and Video-assisted teaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 15 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Nursing education plays a vital role in equipping student nurses with the necessary knowledge and skills to become competent and reliable healthcare professionals. The use of interactive methods in education has a significant impact on enhancing nursing students' competencies. There is a lack of sufficient research in the literature regarding the effectiveness of teach-back and video-supported instruction on the safe use of medical devices. Hence, this study aims to compare the effectiveness of teach-back and video-supported teaching methods in enhancing nursing students' competencies in the safe use of medical devices.
The research will be conducted between September 2023 and May 2024 in a designated training room at the hospital where the clinical training of senior nursing students takes place. The sample of the study will consist of a total of 105 students, who will be divided into three groups using randomization: a teach-back group (35 students), a video-supported instruction group (35 students), and a control group (35 students). Data will be collected using the Student Information Form, Medical Device Usage Competency Self-Assessment Form, Medical Device Usage Competency Knowledge Test, and Medical Device Usage Competency Observer Evaluation Form. For data analysis, the normality of the data will first be determined using the Shapiro-Wilk normality test. Parametric tests will be used for normally distributed data, while non-parametric tests will be used for non-normally distributed data.
- Conditions
- Nurse's Role
- Being tested
- Teach-back, Video-assisted teaching
- Keywords
- Competency, Medical devices, Nursing, Teach-Back, Students, Video-assisted teaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach-backOther
According to the prepared educational materials for medical devices, students will be trained using the teach-back method.
Video-assisted teachingOther
Students will be sent educational videos related to medical devices and asked to watch them.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Video-assisted teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start15 Nov 2023
- Primary completion25 Feb 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha CENGİZ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952323
- Sponsor's protocol ID
- 2023/4644
- Status last verified
- Nov 2024
- First submitted
- 11 Jul 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This research is a doctoral thesis study. The research is expected to be completed.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Teaching Methods in Increasing Nursing Students' Competencies for Safe Use of Medical Devices
- ClinicalTrials.gov ID
- NCT05952323
- Acronym / sponsor ID
- 2023/4644
- Conditions
- Nurse's Role
- Keywords
- Competency, Medical devices, Nursing, Teach-Back, Students, Video-assisted teaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 19 Jul 2023 (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.
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.
Detailed description
Nursing education plays a vital role in equipping student nurses with the necessary knowledge and skills to become competent and reliable healthcare professionals. The use of interactive methods in education has a significant impact on enhancing nursing students' competencies. There is a lack of sufficient research in the literature regarding the effectiveness of teach-back and video-supported instruction on the safe use of medical devices. Hence, this study aims to compare the effectiveness of teach-back and video-supported teaching methods in enhancing nursing students' competencies in the safe use of medical devices.
The research will be conducted between September 2023 and May 2024 in a designated training room at the hospital where the clinical training of senior nursing students takes place. The sample of the study will consist of a total of 105 students, who will be divided into three groups using randomization: a teach-back group (35 students), a video-supported instruction group (35 students), and a control group (35 students). Data will be collected using the Student Information Form, Medical Device Usage Competency Self-Assessment Form, Medical Device Usage Competency Knowledge Test, and Medical Device Usage Competency Observer Evaluation Form. For data analysis, the normality of the data will first be determined using the Shapiro-Wilk normality test. Parametric tests will be used for normally distributed data, while non-parametric tests will be used for non-normally distributed data.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Teach-backTo 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. |
| Video-assisted teaching group | Experimental | Other: Video-assisted teachingAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Teach-backAccording to the prepared educational materials for medical devices, students will be trained using the teach-back method. | Other | Teach-back group |
| Video-assisted teachingStudents will be sent educational videos related to medical devices and asked to watch them. | Other | Video-assisted teaching group |
Primary outcome
The Medical Device Usage Competency Self-Assessment Form
Time frame: 6 months
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.
The Medical Device Usage Competency Knowledge Test
Time frame: 6 months
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.
The Medical Device Usage Competency Observer Evaluation Form
Time frame: 6 months
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.
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 14 Nov 2024.
- Individual participant dataSharing planned: No. This research is a doctoral thesis study. The research is expected to be completed.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach-back and Video-assisted teaching in people with Nurse's Role, run by Inonu 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 6 inclusion and 3 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 14 Nov 2024. 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?
The Medical Device Usage Competency Self-Assessment Form (time frame: 6 months). The study lists 3 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 14 Nov 2024.