Students, NursingNCT05661214
The Effect of Using Clinical Decision Support System in Pressure Injury Risk Management Teaching
A study testing Teaching in people with Students, Nursing, run by Hacettepe University.
Trial summary
The goal of this randomized controlled study is to compare the changes in cognitive, attitudinal and psychomotor domains for pressure injury between nursing students who take model-based structured pressure injury risk management teaching by examining risk factors and plan nursing interventions through sample cases… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Students, Nursing
- What is being tested?
- Teaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2023to 22 Jan 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
- The nursing student must be completed Fundamentals of Nursing course and its clinical practices.
Who cannot join
- The nursing student cannot be a part of this study, if she/he graduated high school/associate degree about health department and work as a health professional.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Using Clinical Decision Support System in Pressure Injury Risk Management Teaching of Nursing Students: A Randomized Controlled Study
The goal of this randomized controlled study is to compare the changes in cognitive, attitudinal and psychomotor domains for pressure injury between nursing students who take model-based structured pressure injury risk management teaching by examining risk factors and plan nursing interventions through sample cases with Clinical Decision Support System (CDSS) integrated software, and nursing students who plan nursing interventions through sample cases on the software by receiving standard teaching. The hypothesis are:
H1: The knowledge of the students who received the model-based structured pressure injury risk management teaching with the CDSS integrated method is different from the control group who received the standard training.
Read more
H1a: The attitudes of the students who received the model-based structured pressure injury risk management instruction with the CDSS integrated method to prevent injuries are different from the control group who received the standard training.
H1b: The nursing interventions planned by the students who received the model-based structured pressure injury risk management education with the CDSS integrated method are different from the control group who received the standard education.
Read the detailed description
The goal of this randomized controlled study is to compare the changes in cognitive, attitudinal and psychomotor domains for pressure injury between nursing students who take model-based structured pressure injury risk management teaching by examining risk factors and plan nursing interventions through sample cases with Clinical Decision Support System (CDSS) integrated software, and nursing students who plan nursing interventions through sample cases on the software by receiving standard teaching.
Method: This randomized controlled trial was planned with two years of nursing students. The study's eligibility criteria are the nursing student must have completed the Fundamentals of Nursing course and clinical practice of this course. The study consists of preparation and implementation phases. The preparation phase consists of the preparation of the training content and software. Researchers will prepare training content and send them to academicians and clinicians who are experts in their fields. Researchers collaborate with software developers to develop the software. After the researchers listed the students who accepted to participate in the study, Students will be randomly assigned to 2 control and two intervention groups by a third researcher who was not involved in the study. The implementation phase of the research will begin with establishing control and intervention groups.
The researchers will first apply the " Pressure Ulcer Prevention Knowledge Assessment Instrument, "Attitude Towards Pressure Ulcer Prevention Instrument " and test case (the pre-tests) to the control 1 group. After that, they will give formal training to both control groups for four weeks and apply the post-tests in the fifth week. They will prepare the nursing care plan, one of the last tests, by analyzing the case via software. After the training of the control groups, the training of the intervention groups will begin. First of all, the intervention 1 group will apply the "Pressure Ulcer Prevention Knowledge Assessment Instrument," "Attitude Towards Pressure Ulcer Prevention Instrument" and the test case (the pre-tests). Afterward, four-week structured training will be given to intervention groups, and post-tests will be applied in the fifth week. They will prepare the nursing care plan, one of the last tests, by analyzing the case through the software integrated with Clinical Decision Support System.
- Conditions
- Students, Nursing
- Being tested
- Teaching
- Keywords
- pressure injury risk management, nursing student, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeachingOther
The intervention in this study is teaching. Researchers, will create a pressure injury teaching content and assess this effectiveness and also, intervention groups will use Clinical Decision Support System (CDSS) as a tool to plan nursing interventions.
| Study group | Role | What they receive |
|---|---|---|
| Control Group 1 | No intervention | This group is the control group 1 (one) that will be taught using structured standard teaching content. Before teaching, participants will be applied pre tests. After teaching, they will be applied post tests. |
| Intervention Group 1 | Experimental | This group is the intervention group 1 (one) that will be taught using model-based structured teaching content. In this teaching content, researchers will teach pressure injury risk factors; after teaching, participants will plan nursing interventions with Clinical Decision Support System (CDSS) integrated software. Before teaching, participants will be applied pre tests. After teaching, they will be applied post tests. Receives: Other: Teaching |
| Control Group 2 | No intervention | This group is the control group 2 (two) that will be taught using structured standard teaching content. After teaching, they will be applied post tests. This group has no pre-test and will be created to increase internal validity, only. |
| Intervention Group 2 | Experimental | This group is the intervention group 2 (two) that will be taught using model-based structured teaching content. In this teaching content, researchers will teach pressure injury risk factors; after teaching, participants will plan nursing interventions with Clinical Decision Support System (CDSS) integrated software. After teaching, they will be applied post tests. This group has no pre-test and will be created to increase internal validity, only. Receives: Other: Teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge levels of nursing students about pressure injury
The first data, will be obtained with the valid and reliable instrument before teaching period (pre-test). After applying the instrument, researchers will teach the nursing students for five weeks. After, the teaching process is over, researchers will apply the same instrument (post-test) to obtain the data of knowledge. The aim is to determine the rate of change in the knowledge levels of nursing students before and after the education.
Measured: 2.5 months (10 weeks)
Attitudes of nursing students about pressure injury
The first data, will be obtained with the valid and reliable instrument before teaching period (pre-test). After applying the instrument, researchers will teach the nursing students for five weeks. After, the teaching process is over, researchers will apply the same instrument (post-test) to obtain the data of attitude. The aim is to determine the rate of change about the attitudes of nursing students before and after the education.
Measured: 2.5 months (10 weeks)
Psychomotor development of nursing students about pressure injury
The first data, will be obtained with the case and nursing care plan before teaching period (pre-test). After applying the instrument, researchers will teach the nursing students for five weeks. After, the teaching process is over, researchers will apply the same case and nursing care plan (post-test) to obtain the data of psychomotor development. The aim is to determine the rate of change about the psychomotor development of nursing students before and after the education.
Measured: 2.5 months (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start2 Oct 2023 (estimated)
- Primary completion22 Jan 2024 (estimated)
- Study completion22 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Students, NursingStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed with Solomon four groups design. There will be control group one, control group two, intervention group one and intervention group two.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Ariburnu, Hacettepe University
- Investigators
- Ozlem Ariburnu, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661214
- Sponsor's protocol ID
- NI 21/633
- Status last verified
- Feb 2023
- First submitted
- 5 Dec 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Clinical Decision Support System in Pressure Injury Risk Management Teaching of Nursing Students: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05661214
- Acronym / sponsor ID
- NI 21/633
- Conditions
- Students, Nursing
- Keywords
- pressure injury risk management, nursing student, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Oct 2023 (estimated)
- Primary completion
- 22 Jan 2024 (estimated)
- Study completion
- 22 Jan 2024 (estimated)
- First posted
- 22 Dec 2022 (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.
The goal of this randomized controlled study is to compare the changes in cognitive, attitudinal and psychomotor domains for pressure injury between nursing students who take model-based structured pressure injury risk management teaching by examining risk factors and plan nursing interventions through sample cases with Clinical Decision Support System (CDSS) integrated software, and nursing students who plan nursing interventions through sample cases on the software by receiving standard teaching. The hypothesis are:
H1: The knowledge of the students who received the model-based structured pressure injury risk management teaching with the CDSS integrated method is different from the control group who received the standard training.
H1a: The attitudes of the students who received the model-based structured pressure injury risk management instruction with the CDSS integrated method to prevent injuries are different from the control group who received the standard training.
H1b: The nursing interventions planned by the students who received the model-based structured pressure injury risk management education with the CDSS integrated method are different from the control group who received the standard education.
Detailed description
The goal of this randomized controlled study is to compare the changes in cognitive, attitudinal and psychomotor domains for pressure injury between nursing students who take model-based structured pressure injury risk management teaching by examining risk factors and plan nursing interventions through sample cases with Clinical Decision Support System (CDSS) integrated software, and nursing students who plan nursing interventions through sample cases on the software by receiving standard teaching.
Method: This randomized controlled trial was planned with two years of nursing students. The study's eligibility criteria are the nursing student must have completed the Fundamentals of Nursing course and clinical practice of this course. The study consists of preparation and implementation phases. The preparation phase consists of the preparation of the training content and software. Researchers will prepare training content and send them to academicians and clinicians who are experts in their fields. Researchers collaborate with software developers to develop the software. After the researchers listed the students who accepted to participate in the study, Students will be randomly assigned to 2 control and two intervention groups by a third researcher who was not involved in the study. The implementation phase of the research will begin with establishing control and intervention groups.
The researchers will first apply the " Pressure Ulcer Prevention Knowledge Assessment Instrument, "Attitude Towards Pressure Ulcer Prevention Instrument " and test case (the pre-tests) to the control 1 group. After that, they will give formal training to both control groups for four weeks and apply the post-tests in the fifth week. They will prepare the nursing care plan, one of the last tests, by analyzing the case via software. After the training of the control groups, the training of the intervention groups will begin. First of all, the intervention 1 group will apply the "Pressure Ulcer Prevention Knowledge Assessment Instrument," "Attitude Towards Pressure Ulcer Prevention Instrument" and the test case (the pre-tests). Afterward, four-week structured training will be given to intervention groups, and post-tests will be applied in the fifth week. They will prepare the nursing care plan, one of the last tests, by analyzing the case through the software integrated with Clinical Decision Support System.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- This study was designed with Solomon four groups design. There will be control group one, control group two, intervention group one and intervention group two.
| Arm | Type | Receives |
|---|---|---|
| Control Group 1 | No intervention | –This group is the control group 1 (one) that will be taught using structured standard teaching content. Before teaching, participants will be applied pre tests. After teaching, they will be applied post tests. |
| Intervention Group 1 | Experimental | Other: TeachingThis group is the intervention group 1 (one) that will be taught using model-based structured teaching content. In this teaching content, researchers will teach pressure injury risk factors; after teaching, participants will plan nursing interventions with Clinical Decision Support System (CDSS) integrated software. Before teaching, participants will be applied pre tests. After teaching, they will be applied post tests. |
| Control Group 2 | No intervention | –This group is the control group 2 (two) that will be taught using structured standard teaching content. After teaching, they will be applied post tests. This group has no pre-test and will be created to increase internal validity, only. |
| Intervention Group 2 | Experimental | Other: TeachingThis group is the intervention group 2 (two) that will be taught using model-based structured teaching content. In this teaching content, researchers will teach pressure injury risk factors; after teaching, participants will plan nursing interventions with Clinical Decision Support System (CDSS) integrated software. After teaching, they will be applied post tests. This group has no pre-test and will be created to increase internal validity, only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The nursing student must be completed Fundamentals of Nursing course and its clinical practices.
Key exclusion criteria (1 listed)
- The nursing student cannot be a part of this study, if she/he graduated high school/associate degree about health department and work as a health professional.
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 |
|---|---|---|
| TeachingThe intervention in this study is teaching. Researchers, will create a pressure injury teaching content and assess this effectiveness and also, intervention groups will use Clinical Decision Support System (CDSS) as a tool to plan nursing interventions. | Other | Intervention Group 1, Intervention Group 2 |
Primary outcome
Knowledge levels of nursing students about pressure injury
Time frame: 2.5 months (10 weeks)
The first data, will be obtained with the valid and reliable instrument before teaching period (pre-test). After applying the instrument, researchers will teach the nursing students for five weeks. After, the teaching process is over, researchers will apply the same instrument (post-test) to obtain the data of knowledge. The aim is to determine the rate of change in the knowledge levels of nursing students before and after the education.
Attitudes of nursing students about pressure injury
Time frame: 2.5 months (10 weeks)
The first data, will be obtained with the valid and reliable instrument before teaching period (pre-test). After applying the instrument, researchers will teach the nursing students for five weeks. After, the teaching process is over, researchers will apply the same instrument (post-test) to obtain the data of attitude. The aim is to determine the rate of change about the attitudes of nursing students before and after the education.
Psychomotor development of nursing students about pressure injury
Time frame: 2.5 months (10 weeks)
The first data, will be obtained with the case and nursing care plan before teaching period (pre-test). After applying the instrument, researchers will teach the nursing students for five weeks. After, the teaching process is over, researchers will apply the same case and nursing care plan (post-test) to obtain the data of psychomotor development. The aim is to determine the rate of change about the psychomotor development of nursing students before and after the education.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Ozlem Ariburnu principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Teaching in people with Students, Nursing, run by Hacettepe University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ozlem Ariburnu (00905369216518, ozlem.ariburnu@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge levels of nursing students about pressure injury (time frame: 2.5 months (10 weeks)). 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 15 Feb 2023.