Educational ProblemsNCT06499558
Teaching Family Planning Skills With Standardized Patients"
A study testing Classical Training and Standard Patient Interviews in people with Educational Problems, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
The research is planned to be carried out in the Simulated Patient Laboratory of Süleyman Demirel University Faculty of Medicine. The population of the research will consist of students taking the Hem 327 Women's Health and Diseases Nursing course in the fall semester of the 2023-2024 academic year (N: 179). Read more about this study
- Who is it for?
- Ages 21 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- Classical Training and Standard Patient Interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 May 2024to 5 Jun 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 21 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be a third-year nursing student at the Faculty of Health Sciences
- To consent to participate in the research.
Who cannot join
- Not completing any stage of the study
- Requesting to withdraw from the study
- Having previously taken the Obstetrics and Gynecology Nursing course
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University Health Sciences Faculty Nursing Department
Isparta, Çünür, 32260
About this study
Official title: Suleyman Demirel University
The research is planned to be carried out in the Simulated Patient Laboratory of Süleyman Demirel University Faculty of Medicine. The population of the research will consist of students taking the Hem 327 Women's Health and Diseases Nursing course in the fall semester of the 2023-2024 academic year (N: 179). Students receive training in small groups of 30-40 people in the professional skills laboratory. It is planned to study with a total of 80 students, 40 in the intervention group and 40 in the control group. Students will be assigned to intervention and control groups by lottery. The entire intervention and control group will receive theoretical training on "Family Planning", which is included in the 327 Women's Health and Diseases Nursing course. The course, conducted by the research faculty member using lecture, question-answer and discussion methods, will last three hours. Students participating in the study during the week of the theoretical course will be asked to fill out the Introductory Characteristics Form and the Family Planning Counseling Information Form.
Read the detailed description
The main purpose of nursing education is; To train healthcare professionals who can combine theoretical knowledge with practice, and who have acquired critical thinking and effective problem-solving skills. Clinical practice is one of the most important elements of nursing teaching. It is thought that simulation training will be effective in preparing students for clinical practice and will increase their self-confidence in clinical practice by improving their clinical decision-making and application skills. Therefore, whether knowledge and skill gains can be transferred to nursing practice is an important area of interest in simulation research. The research is planned to be carried out in the Simulated Patient Laboratory of Süleyman Demirel University Faculty of Medicine. The population of the research will consist of students taking the Hem 327 Women's Health and Diseases Nursing course in the fall semester of the 2023-2024 academic year (N: 179). Students receive training in small groups of 30-40 people in the professional skills laboratory. It is planned to study with a total of 80 students, 40 in the intervention group and 40 in the control group. Students will be assigned to intervention and control groups by lottery. The entire intervention and control group will receive theoretical training on "Family Planning", which is included in the 327 Women's Health and Diseases Nursing course. The course, conducted by the research faculty member using lecture, question-answer and discussion methods, will last three hours. Students participating in the study during the week of the theoretical course will be asked to fill out the Introductory Characteristics Form and the Family Planning Counseling Information Form. In the same week, students in the control group will practice family planning education skills in the vocational skills laboratory. At the end of the application, students will fill out the Effective Communication Skills Evaluation Form and the Family Planning Education Skills Evaluation Form. Students in the intervention group are; They will participate in standard patient education that includes a family planning counseling scenario. Students will be given preliminary information before encountering a standard patient. During standard patient preparations; standard patients will be informed about the scenarios. Standard clothes and additional materials that patients will use while performing the scenario will be provided. Care will be taken to ensure that individuals serving as standard patients have previously taken part in other studies as standard patients. Then, the student will be brought together with the standard patient in the standard patient room of the clinical simulation training laboratory and a video recording will be taken at this time. The standard patient will behave in accordance with the patient role in the scenario given to him by the researcher. The application recording will be monitored by the researcher and the observer in the observation room in the standard patient room, and the Effective Communication Skills Evaluation Form and Family Planning Education Skill Evaluation Form will be filled in to evaluate the skill levels of the students. Then, a debriefing session will be held in the debriefing room, in line with the debriefing questions. Meanwhile, students will be given feedback on their deficiencies and performance in the application. Students' satisfaction and self-confidence towards this education will be evaluated with the Student Satisfaction and Self-Confidence Scale in Learning. The evaluation of the data will be done on a computer using the SPSS (Statistical Package For Social Sciences) 21.0 package program. In the analysis of data, percentage distributions, mean, standard deviation, chi-square test, and t-test in dependent groups will be used. Research findings will be evaluated at a 95% confidence interval and a significance level of p<0.05. In order to conduct the research, ethics committee approval was obtained from the Süleyman Demirel University Ethics Committee Presidency and legal permission was obtained from the Dean's Office of Süleyman Demirel University Faculty of Medicine, where the research will be conducted.
- Conditions
- Educational Problems
- Being tested
- Classical Training, Standard Patient Interviews
- Keywords
- education, family planning, standard patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical TrainingOther
Students in the education group will practice family planning education skills in the professional skills laboratory.
Standard Patient InterviewsOther
Students in the standardized patient education group will receive training involving a family planning counseling scenario with standardized patients.
| Study group | Role | What they receive |
|---|---|---|
| Classical Training | Other | In the professional skills laboratory, students in the control group will practice family planning education skills Receives: Other: Classical Training |
| Standard Patient Interviews | Other | Students in the standard patient education group will receive standard patient education including a family planning counseling scenario. Receives: Other: Standard Patient Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard patient practice has an impact on students' satisfaction level.
Student Satisfaction and Confidence Scale in Learning
Measured: through study completion, an average of 6 month
Secondary outcomes (1)
The effect of standardized patient practice on students' self-confidence has been investigated
Family Planning Counseling Information Form, Effective Communication Form,Family Planning Education Skills Assessment Form
Measured: through study completion, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start31 May 2024
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study, participants are divided into two groups: the laboratory training group (the group receiving standard training) and the group receiving standard patient training.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur Atasever, Suleyman Demirel University
- Investigators
- Ilknur Atasever, Assist. Prof., Principal investigator, Suleyman Demirel UniversityIlknur Atasever, Assist. Prof.., Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499558
- Sponsor's protocol ID
- u3mjm2ey
- Status last verified
- Jul 2024
- First submitted
- 23 May 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our plan aims to ensure transparent sharing of research results and accessibility to the scientific community. Individual participant data will be safeguarded in accordance with privacy standards.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suleyman Demirel University
- ClinicalTrials.gov ID
- NCT06499558
- Acronym / sponsor ID
- u3mjm2ey
- Conditions
- Educational Problems
- Keywords
- education, family planning, standard patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 12 Jul 2024 (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 research is planned to be carried out in the Simulated Patient Laboratory of Süleyman Demirel University Faculty of Medicine. The population of the research will consist of students taking the Hem 327 Women's Health and Diseases Nursing course in the fall semester of the 2023-2024 academic year (N: 179). Students receive training in small groups of 30-40 people in the professional skills laboratory. It is planned to study with a total of 80 students, 40 in the intervention group and 40 in the control group. Students will be assigned to intervention and control groups by lottery. The entire intervention and control group will receive theoretical training on "Family Planning", which is included in the 327 Women's Health and Diseases Nursing course. The course, conducted by the research faculty member using lecture, question-answer and discussion methods, will last three hours. Students participating in the study during the week of the theoretical course will be asked to fill out the Introductory Characteristics Form and the Family Planning Counseling Information Form.
Detailed description
The main purpose of nursing education is; To train healthcare professionals who can combine theoretical knowledge with practice, and who have acquired critical thinking and effective problem-solving skills. Clinical practice is one of the most important elements of nursing teaching. It is thought that simulation training will be effective in preparing students for clinical practice and will increase their self-confidence in clinical practice by improving their clinical decision-making and application skills. Therefore, whether knowledge and skill gains can be transferred to nursing practice is an important area of interest in simulation research. The research is planned to be carried out in the Simulated Patient Laboratory of Süleyman Demirel University Faculty of Medicine. The population of the research will consist of students taking the Hem 327 Women's Health and Diseases Nursing course in the fall semester of the 2023-2024 academic year (N: 179). Students receive training in small groups of 30-40 people in the professional skills laboratory. It is planned to study with a total of 80 students, 40 in the intervention group and 40 in the control group. Students will be assigned to intervention and control groups by lottery. The entire intervention and control group will receive theoretical training on "Family Planning", which is included in the 327 Women's Health and Diseases Nursing course. The course, conducted by the research faculty member using lecture, question-answer and discussion methods, will last three hours. Students participating in the study during the week of the theoretical course will be asked to fill out the Introductory Characteristics Form and the Family Planning Counseling Information Form. In the same week, students in the control group will practice family planning education skills in the vocational skills laboratory. At the end of the application, students will fill out the Effective Communication Skills Evaluation Form and the Family Planning Education Skills Evaluation Form. Students in the intervention group are; They will participate in standard patient education that includes a family planning counseling scenario. Students will be given preliminary information before encountering a standard patient. During standard patient preparations; standard patients will be informed about the scenarios. Standard clothes and additional materials that patients will use while performing the scenario will be provided. Care will be taken to ensure that individuals serving as standard patients have previously taken part in other studies as standard patients. Then, the student will be brought together with the standard patient in the standard patient room of the clinical simulation training laboratory and a video recording will be taken at this time. The standard patient will behave in accordance with the patient role in the scenario given to him by the researcher. The application recording will be monitored by the researcher and the observer in the observation room in the standard patient room, and the Effective Communication Skills Evaluation Form and Family Planning Education Skill Evaluation Form will be filled in to evaluate the skill levels of the students. Then, a debriefing session will be held in the debriefing room, in line with the debriefing questions. Meanwhile, students will be given feedback on their deficiencies and performance in the application. Students' satisfaction and self-confidence towards this education will be evaluated with the Student Satisfaction and Self-Confidence Scale in Learning. The evaluation of the data will be done on a computer using the SPSS (Statistical Package For Social Sciences) 21.0 package program. In the analysis of data, percentage distributions, mean, standard deviation, chi-square test, and t-test in dependent groups will be used. Research findings will be evaluated at a 95% confidence interval and a significance level of p<0.05. In order to conduct the research, ethics committee approval was obtained from the Süleyman Demirel University Ethics Committee Presidency and legal permission was obtained from the Dean's Office of Süleyman Demirel University Faculty of Medicine, where the research will be conducted.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the study, participants are divided into two groups: the laboratory training group (the group receiving standard training) and the group receiving standard patient training.
| Arm | Type | Receives |
|---|---|---|
| Classical Training | Other | Other: Classical TrainingIn the professional skills laboratory, students in the control group will practice family planning education skills |
| Standard Patient Interviews | Other | Other: Standard Patient InterviewsStudents in the standard patient education group will receive standard patient education including a family planning counseling scenario. |
Who may qualify
- Ages
- 21 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- To be a third-year nursing student at the Faculty of Health Sciences
- To consent to participate in the research.
Key exclusion criteria (3 listed)
- Not completing any stage of the study
- Requesting to withdraw from the study
- Having previously taken the Obstetrics and Gynecology Nursing course
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 |
|---|---|---|
| Classical TrainingStudents in the education group will practice family planning education skills in the professional skills laboratory. | Other | Classical Training |
| Standard Patient InterviewsStudents in the standardized patient education group will receive training involving a family planning counseling scenario with standardized patients. | Other | Standard Patient Interviews |
Primary outcome
Standard patient practice has an impact on students' satisfaction level.
Time frame: through study completion, an average of 6 month
Student Satisfaction and Confidence Scale in Learning
1 secondary outcome
The effect of standardized patient practice on students' self-confidence has been investigated
Time frame: through study completion, an average of 6 month
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 12 Jul 2024.
- Individual participant dataSharing planned: No. Our plan aims to ensure transparent sharing of research results and accessibility to the scientific community. Individual participant data will be safeguarded in accordance with privacy standards.
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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.
Ilknur Atasever, Assist. Prof. principal investigator
Suleyman Demirel University
Ilknur Atasever, Assist. Prof.. principal investigator
Suleyman Demirel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical Training and Standard Patient Interviews in people with Educational Problems, run by Suleyman Demirel 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 2 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 12 Jul 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?
Standard patient practice has an impact on students' satisfaction level. (time frame: through study completion, an average of 6 month). 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 12 Jul 2024.