Teaching Family Planning Skills With Standardized Patients"

July 10, 2024 updated by: İlknur Atasever, Suleyman Demirel University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çünür
      • Isparta, Çünür, Turkey, 32260
        • Suleyman Demirel University Health Sciences Faculty Nursing Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- To be a third-year nursing student at the Faculty of Health Sciences

• To consent to participate in the research.

Exclusion Criteria:

  • Not completing any stage of the study
  • Requesting to withdraw from the study
  • Having previously taken the Obstetrics and Gynecology Nursing course

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Classical Training
In the professional skills laboratory, students in the control group will practice family planning education skills
Other: Classical Training
Students in the education group will practice family planning education skills in the professional skills laboratory.
Other: Standard Patient Interviews
Students in the standard patient education group will receive standard patient education including a family planning counseling scenario.
Other: Standard Patient Interviews
Students in the standardized patient education group will receive training involving a family planning counseling scenario with standardized patients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The effect of standardized patient practice on students' self-confidence has been investigated
Time Frame: through study completion, an average of 6 month
Family Planning Counseling Information Form, Effective Communication Form,Family Planning Education Skills Assessment Form
through study completion, an average of 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suleyman Demirel University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ilknur Atasever, Assist. Prof., Suleyman Demirel University
  • Principal Investigator: Ilknur Atasever, Assist. Prof.., Suleyman Demirel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • u3mjm2ey

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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