PreeclampsiaNCT04915794
Preeclamptic Pregnancy Care Education
A study testing Simulation of preeclamptic pregnancy care in people with Preeclampsia and Nurse's Role, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of simulation training in nurses and midwives on knowledge and self-efficacy regarding preeclamptic pregnancy care. It is an important step in providing safe care to patients, as a learning environment is provided in which environmental risks are minimized with… Read more about this study
- Who is it for?
- Ages 22 to 35 years, women only
- Conditions the study is for
- Preeclampsia, Nurse's Role
- What is being tested?
- Simulation of preeclamptic pregnancy care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2020to 17 Aug 2020
- 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 22 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Working for 1-5 years.
- Working in the gynecology inpatient services and delivery rooms of hospitals.
- To be a graduate nurse or midwife.
- Volunteering to participate in the study.
Who cannot join
- Being a high school graduate working in the related field
- Having just graduated from a related field
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Simulation on Knowledge and Self-efficacy of Nurses and Midwives in Preeclamptic Pregnancy Care Education
The aim of this study is to evaluate the effect of simulation training in nurses and midwives on knowledge and self-efficacy regarding preeclamptic pregnancy care.
It is an important step in providing safe care to patients, as a learning environment is provided in which environmental risks are minimized with simulation applications. Simulation-based trainings are environments that allow each student to learn, equitable, based on adult learning principles, and open to different learning styles. The interests and needs in these environments are defined together by the learner and the educator. By keeping the experiences of the learner at the forefront, the opportunity is given to learn by doing and supported with feedback.
Read more
Preeclampsia is clinically defined as a blood pressure of 140/90 mmHg or above after the 20th week of pregnancy and the addition of proteinuria (300mg / 24 hours). It can develop in about 5-10% of all pregnancies. It is defined as a nulliparous disease since it is seen in approximately 85% of women during their first pregnancy. Preeclampsia constitutes 15% of the causes of maternal mortality in our country.
In studies evaluating the effectiveness of simulation training in planning the follow-up and care of preeclampsia, it was determined that this method increases the knowledge and self-confidence of nurses. For example; Christian and Krumwiede's study they found that the self-efficacy rates were significantly higher in the post-simulation test. In his study, Olubumno investigated the importance of simulation in increasing the critical thinking of perinatology nurses in the care of preeclamptic pregnant women, he found that the pre-test and post-test scores increased by 0.75 points, and this difference between the scores is statistically significant. Tabatabaeian et al., In their study comparing the effects of simulation-based education, coeducation and theoretical education on the performance of midwives in preeclampsia and eclampsia, found that the mean of the simulation group was higher than the other two groups.
Preeclampsia is an important obstetric emergency in women's health and disease nursing. Thus, when they start working in the clinic, it is aimed to be able to suspect preeclampsia with the anamnesis they received from the pregnant who applied to them, and to gain them with the simulation method what they should pay attention to and how to do in the follow-up of the pregnant woman hospitalized with the diagnosis of preeclampsia. Studies conducted in our country did not include studies involving students and healthcare professionals in the management of preeclampsia with simulation methods. Therefore, it is aimed to contribute to the literature with this study.
- Conditions
- Preeclampsia, Nurse's Role
- Being tested
- Simulation of preeclamptic pregnancy care
- Keywords
- Preeclampsia, Self-efficacy
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation of preeclamptic pregnancy careOther
It is an important step in providing safe care to patients, as a learning environment is provided in which environmental risks are minimized with simulation applications. Simulation-based trainings are environments that allow each student to learn, equitable, based on adult learning principles, and open to different learning styles. In these environments, interests and needs are defined together by the learner and the educator. By keeping the experiences of the learner at the forefront, the opportunity is given to learn by doing and is supported with feedback.
| Study group | Role | What they receive |
|---|---|---|
| Simulation based education | Experimental | Simulation is a technique that creates a situation or environment that allows people to experience the representation of a real event, practice, learn, evaluate, test, or gain an understanding of systems or human actions Receives: Other: Simulation of preeclamptic pregnancy care |
| Traditional education | No intervention | Necessary procedures explained theoretically |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of knowledge about preeclamptic pregnancy care is higher in the group that received training with the lecturing and high-reality simulation method compared to the group that received training only with lectures
"Self-efficacy for preeclamptic pregnancy care" scale was developed and used in the follow-up and care of preeclamptic pregnant women in order to evaluate the perception of self-efficacy towards nursing care in critical obstetric conditions related to preeclampsia in nurses and midwives. It's a 20-item instrument using a five-point scale.
Measured: Six weeks
Secondary outcomes (2)
Educational Practices Questionnaire
The Educational Practices in Simulation Scale (EPSS), a 16-item instrument using a five-point scale, was designed to measure whether four educational practices (active learning, collaboration, diverse ways of learning, and high expectations) are present in the instructor-developed simulation, and the importance of each practice to the learner.
Measured: One week after theoretical training
Student Satisfaction and Self-Confidence in Learning Scale
A total of 13 items assess the attitudes toward satisfaction with instruction and self-confidence in learning in simulation. A "satisfaction with instruction" subscale contains five items measuring satisfaction with teaching methods, diversity of learning materials, facilitation, motivation, and overall suitability of simulation. A "self-confidence with learning" subscale contains eight items measuring self-confidence in content mastery, content necessity, skills development, available resources, and knowledge of how to obtain help to solve clinical problems in simulation.
Measured: One week after theoretical training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start10 Jul 2020
- Primary completion18 Jul 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Küğcümen, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915794
- Sponsor's protocol ID
- 10377247
- Status last verified
- Jun 2021
- First submitted
- 26 Jan 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Simulation on Knowledge and Self-efficacy of Nurses and Midwives in Preeclamptic Pregnancy Care Education
- ClinicalTrials.gov ID
- NCT04915794
- Acronym / sponsor ID
- 10377247
- Conditions
- Preeclampsia, Nurse's Role
- Keywords
- Preeclampsia, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 18 Jul 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 7 Jun 2021 (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 aim of this study is to evaluate the effect of simulation training in nurses and midwives on knowledge and self-efficacy regarding preeclamptic pregnancy care.
It is an important step in providing safe care to patients, as a learning environment is provided in which environmental risks are minimized with simulation applications. Simulation-based trainings are environments that allow each student to learn, equitable, based on adult learning principles, and open to different learning styles. The interests and needs in these environments are defined together by the learner and the educator. By keeping the experiences of the learner at the forefront, the opportunity is given to learn by doing and supported with feedback.
Preeclampsia is clinically defined as a blood pressure of 140/90 mmHg or above after the 20th week of pregnancy and the addition of proteinuria (300mg / 24 hours). It can develop in about 5-10% of all pregnancies. It is defined as a nulliparous disease since it is seen in approximately 85% of women during their first pregnancy. Preeclampsia constitutes 15% of the causes of maternal mortality in our country.
In studies evaluating the effectiveness of simulation training in planning the follow-up and care of preeclampsia, it was determined that this method increases the knowledge and self-confidence of nurses. For example; Christian and Krumwiede's study they found that the self-efficacy rates were significantly higher in the post-simulation test. In his study, Olubumno investigated the importance of simulation in increasing the critical thinking of perinatology nurses in the care of preeclamptic pregnant women, he found that the pre-test and post-test scores increased by 0.75 points, and this difference between the scores is statistically significant. Tabatabaeian et al., In their study comparing the effects of simulation-based education, coeducation and theoretical education on the performance of midwives in preeclampsia and eclampsia, found that the mean of the simulation group was higher than the other two groups.
Preeclampsia is an important obstetric emergency in women's health and disease nursing. Thus, when they start working in the clinic, it is aimed to be able to suspect preeclampsia with the anamnesis they received from the pregnant who applied to them, and to gain them with the simulation method what they should pay attention to and how to do in the follow-up of the pregnant woman hospitalized with the diagnosis of preeclampsia. Studies conducted in our country did not include studies involving students and healthcare professionals in the management of preeclampsia with simulation methods. Therefore, it is aimed to contribute to the literature with this study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation based education | Experimental | Other: Simulation of preeclamptic pregnancy careSimulation is a technique that creates a situation or environment that allows people to experience the representation of a real event, practice, learn, evaluate, test, or gain an understanding of systems or human actions |
| Traditional education | No intervention | –Necessary procedures explained theoretically |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Working for 1-5 years.
- Working in the gynecology inpatient services and delivery rooms of hospitals.
- To be a graduate nurse or midwife.
- Volunteering to participate in the study.
Key exclusion criteria (2 listed)
- Being a high school graduate working in the related field
- Having just graduated from a related field
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 |
|---|---|---|
| Simulation of preeclamptic pregnancy careIt is an important step in providing safe care to patients, as a learning environment is provided in which environmental risks are minimized with simulation applications. Simulation-based trainings are environments that allow each student to learn, equitable, based on adult learning principles, and open to different learning styles. In these environments, interests and needs are defined together by the learner and the educator. By keeping the experiences of the learner at the forefront, the opportunity is given to learn by doing and is supported with feedback. | Other | Simulation based education |
Primary outcome
The level of knowledge about preeclamptic pregnancy care is higher in the group that received training with the lecturing and high-reality simulation method compared to the group that received training only with lectures
Time frame: Six weeks
"Self-efficacy for preeclamptic pregnancy care" scale was developed and used in the follow-up and care of preeclamptic pregnant women in order to evaluate the perception of self-efficacy towards nursing care in critical obstetric conditions related to preeclampsia in nurses and midwives. It's a 20-item instrument using a five-point scale.
2 secondary outcomes
Educational Practices Questionnaire
Time frame: One week after theoretical training
Student Satisfaction and Self-Confidence in Learning Scale
Time frame: One week after theoretical training
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 7 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Active, not recruitingObservational study
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
Preeclampsia (PE)
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
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 Simulation of preeclamptic pregnancy care in people with Preeclampsia and Nurse's Role, run by Istanbul University - Cerrahpasa 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 4 inclusion and 2 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 7 Jun 2021. 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 level of knowledge about preeclamptic pregnancy care is higher in the group that received training with the lecturing and high-reality simulation method compared to the group that received training only with lectures (time frame: Six weeks). 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 7 Jun 2021.