Educational ProblemsNCT07229183
Family Planning Counseling and Simulation
A study testing Standardized patient simulation practice and Peer Simulation practice in people with Educational Problems, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this experimental study is to investigate the effects of standardized patient simulation and peer simulation on midwifery students' family planning counseling and material development skills. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Educational Problems
- What is being tested?
- Standardized patient simulation practice and Peer Simulation practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2025to 28 May 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Students taking the course for the first time
- Students who agree to participate in the research
- Students who continue the theoretical part of the course
Who cannot join
- Students who did not attend simulation sessions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpaşa Üniversitesi
Tokat Province, Central, 60250
About this study
Official title: Midwifery Students' Family Planning Counseling and Material Development Skills and the Effectiveness of Standardized Patient Simulation and Peer Simulation
The purpose of this experimental study is to investigate the effects of standardized patient simulation and peer simulation on midwifery students' family planning counseling and material development skills.
The main questions it aims to answer are:
Read more
Do standardized patient simulation and peer simulation training affect midwifery students' family planning counseling skills?
Do standardized patient simulation and peer simulation training affect midwifery students' material development skills?
The researchers will compare simulation groups with a control group to determine whether simulation training improves midwifery students' family planning counseling and material development skills.
Participants:
For the peer simulation, three volunteer second-year midwifery students will portray a peer in the client role.
Three volunteer undergraduate/master's students with prior theater training will portray a standardized patient in the client role.
The control group, without receiving simulation training, will prepare educational material on general family planning counseling after the simulation sessions and present this material to their peers in a classroom setting as a counseling practice.
Simulation groups will complete the State/Trait Anxiety Inventory before simulation and family planning counseling, and the control group will complete the State/Trait Anxiety Inventory before family planning counseling.
Read the detailed description
The goal of family planning services is to improve pregnancy planning and spacing and to prevent unintended pregnancies. They enable individuals to achieve desired birth spacing and family size and contribute to improved health outcomes for children, women, and families. According to the World Health Organization (2014) and the United Nations (2014), all couples and individuals have the right to freely and responsibly decide on the number, spacing, and timing of their children and to have the information and tools necessary to do so. Family planning provides multifaceted benefits for women and their families.
It is unique among health interventions in terms of its breadth of health, development, and economic benefits, including reducing maternal and child mortality, empowering women and girls, and increasing environmental sustainability. Midwives play a crucial role in improving maternal and infant health and providing family planning and reproductive health services.
Family planning relies, in part, on the communication skills and attitudes of healthcare providers involved in counseling. A study demonstrated that a client-centered approach to family planning counseling, which fosters shared decision-making, builds trust, and explores client preferences, increases satisfaction and retention. Another study suggests that midwifery students need more practical training in contraception and sexual health.
The use of printed educational materials is recommended to supplement and reinforce health information commonly delivered orally, thereby increasing the effectiveness of health education. According to Bernier, written educational materials offer a number of advantages, including message consistency, reusability, portability, distribution flexibility, information retention, and cost-effectiveness of production and updating. Healthcare professionals should provide written health education materials designed according to best-practice principles in written health education material design and focused on the healthy/ill individual. Health education materials are only effective if they are read, understood, and remembered by healthy/ill individuals.
By writing their own educational materials, health educators can adapt content to the policies, procedures, and equipment of their respective institutions, create answers to frequently asked questions by healthy and sick individuals, emphasize points deemed particularly important by healthcare professionals, and reinforce specific verbal instructions that clarify difficult concepts and address specific healthy and sick needs.
In this context, enhancing midwifery students' material development skills is crucial.
Standardized patients are individuals who have received special training to accurately convey a patient's story so accurately that even experienced healthcare professionals cannot distinguish them from real patients. By embodying all the physical and psychological characteristics of real patients, they provide students with a holistic understanding of patient care. These individuals are frequently used in health sciences education to promote the development of communication skills and other core competencies.
They can consistently represent a wide variety of scenarios. Issues such as high cost, standardized patient training, and other limitations limit the use of standardized patients in health education. A potential alternative to standardized patients is to have students role-play the patient. Peer simulation is an advanced form of role-playing in which students are trained to role-play clinical scenarios for their peers. While there are studies examining the impact of simulation on improving family planning counseling, no studies have been found comparing the effectiveness of standardized patient simulation with peer simulation.
In addition, this study focuses on the ability to prepare educational materials on the subject as well as family planning counseling.
- Conditions
- Educational Problems
- Being tested
- Standardized patient simulation practice, Peer Simulation practice
- Keywords
- midwifery student, family planning, peer simulation, standardized patient simulation, education material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized patient simulation practiceBehavioural
Creating family planning scenarios Preparing educational materials Identifying and training standardized patients on the scenarios Providing family planning counseling with standardized patients in simulation sessions accompanied by educational materials
Peer Simulation practiceBehavioural
Creating family planning scenarios Preparing educational materials Identifying and training peers on the scenarios Providing family planning counseling in simulation sessions with peers using educational materials
| Study group | Role | What they receive |
|---|---|---|
| Standardized Patient Group | Experimental | Trained with SP in simulation sessions Receives: Behavioral: Standardized patient simulation practice |
| Peer Simulation Group | Experimental | Trained with a peer in simulation sessions Receives: Behavioral: Peer Simulation practice |
| Control Group | No intervention | No intervention was made |
What is being measured
The primary outcome is the main question the study is designed to answer.
State/Trait Anxiety Inventory
- Not at all,
- A little,
- A lot, and 4) Completely
Measured: Pre-simulation (Baseline) and Pre-family planning counseling
General Counseling Evaluation Form in Family Planning
"1 = needs improvement" (steps are implemented incorrectly or skipped),
"2 = adequate" (steps are implemented correctly and in the correct order, but progress from step to step is not smooth),
"3 = mastered" (steps are implemented correctly and in the correct order, and progress is smooth from step to step)
Measured: Throughout family planning counseling-10 minutes
Patient Education Material Evaluation Tool
Disagree = 0 points Agree = 1 point No Rating
Measured: Pre-family planning counseling- 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start6 May 2025
- Primary completion9 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were divided into three groups: standardized patient simulation, peer simulation, and control group.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Döndü BATKIN ERTÜRK, Tokat Gaziosmanpasa University
- Investigators
- Döndü BATKIN ERTÜRK, Assist.Prof., Principal investigator, Tokat Gaziosmanpaşa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229183
- Sponsor's protocol ID
- TOKAT05
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma KA, Zangmo R, Kumari A, Roy KK, Bharti J. Family planning and abortion services in COVID 19 pandemic. Taiwan J Obstet Gynecol. 2020 Nov;59(6):808-811. doi: 10.1016/j.tjog.2020.09.005. Epub 2020 Sep 10.
PubMed 33218393Ensuring Human Rights in the Provision of Contraceptive Information and Services: Guidance and Recommendations. Geneva: World Health Organization; 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK195054/
PubMed 24696891United Nations Population Fund (2023) Human Rights-Based Approach To Family Planning, UNFPA Support Tool. Available at: https://www.unfpa.org/sites/default/files/pub-pdf/UNFPA-HRBAtoFP-SupportTool-v231207.pdf Accessed:18 March 2025
Şimşek Çetinkaya, Ş., Gümüş Çalış, G., Kıbrıs, Ş., & Topal, M. (2024). Effectiveness of virtual patient simulation versus peer simulation in family planning training in midwifery students: a comparative educational intervention. Interactive Learning Environments, 32(3), 942-951.
Li Q, Rimon JG, Ahmed S. Capitalising on shared goals for family planning: a concordance assessment of two global initiatives using longitudinal statistical models. BMJ Open. 2019 Nov 12;9(11):e031425. doi: 10.1136/bmjopen-2019-031425.
PubMed 31722946Inurreta-Díaz, M., Morales-Gual, Y. M., Aguilar-Vargas, E., Álvarez-Baeza, A., Magriñá-Lizama, J. S., Cetina-Sauri, G., & Méndez-Domínguez, N. (2021). Family-Planning counselling simulation for medical students: An exploratory educational intervention. Educación médica, 22, 271-276.
Schivone GB, Glish LL. Contraceptive counseling for continuation and satisfaction. Curr Opin Obstet Gynecol. 2017 Dec;29(6):443-448. doi: 10.1097/GCO.0000000000000408.
PubMed 28938374Walker SH, Davis G. Knowledge and reported confidence of final year midwifery students regarding giving advice on contraception and sexual health. Midwifery. 2014 May;30(5):e169-76. doi: 10.1016/j.midw.2014.02.002. Epub 2014 Feb 25.
PubMed 24661469Sim, K. H. (2011). Tips for creating effective health education materials. The Journal of Korean Diabetes, 12(2), 99-103.
Hoffmann T, Worrall L. Designing effective written health education materials: considerations for health professionals. Disabil Rehabil. 2004 Oct 7;26(19):1166-73. doi: 10.1080/09638280410001724816.
PubMed 15371031Hainsworth D. & Keyes K. Chapter 12: Instructional materials. In: Bastable SB. (ed.) Nurse as educator: Principles of teaching and learning for nursing practice, Fifth Edition Jones & Bartlett Learning; 2019. p 505-48.
Ghorbani B, Jackson AC, Dehghan-Nayeri N, Bahramnezhad F. Standardized patients' experience of participating in medical students' education: a qualitative content analysis. BMC Med Educ. 2024 May 28;24(1):586. doi: 10.1186/s12909-024-05531-x.
PubMed 38807118
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midwifery Students' Family Planning Counseling and Material Development Skills and the Effectiveness of Standardized Patient Simulation and Peer Simulation
- ClinicalTrials.gov ID
- NCT07229183
- Acronym / sponsor ID
- TOKAT05
- Conditions
- Educational Problems
- Keywords
- midwifery student, family planning, peer simulation, standardized patient simulation, education material
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 14 Nov 2025 (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 purpose of this experimental study is to investigate the effects of standardized patient simulation and peer simulation on midwifery students' family planning counseling and material development skills.
The main questions it aims to answer are:
Do standardized patient simulation and peer simulation training affect midwifery students' family planning counseling skills?
Do standardized patient simulation and peer simulation training affect midwifery students' material development skills?
The researchers will compare simulation groups with a control group to determine whether simulation training improves midwifery students' family planning counseling and material development skills.
Participants:
For the peer simulation, three volunteer second-year midwifery students will portray a peer in the client role.
Three volunteer undergraduate/master's students with prior theater training will portray a standardized patient in the client role.
The control group, without receiving simulation training, will prepare educational material on general family planning counseling after the simulation sessions and present this material to their peers in a classroom setting as a counseling practice.
Simulation groups will complete the State/Trait Anxiety Inventory before simulation and family planning counseling, and the control group will complete the State/Trait Anxiety Inventory before family planning counseling.
Detailed description
The goal of family planning services is to improve pregnancy planning and spacing and to prevent unintended pregnancies. They enable individuals to achieve desired birth spacing and family size and contribute to improved health outcomes for children, women, and families. According to the World Health Organization (2014) and the United Nations (2014), all couples and individuals have the right to freely and responsibly decide on the number, spacing, and timing of their children and to have the information and tools necessary to do so. Family planning provides multifaceted benefits for women and their families.
It is unique among health interventions in terms of its breadth of health, development, and economic benefits, including reducing maternal and child mortality, empowering women and girls, and increasing environmental sustainability. Midwives play a crucial role in improving maternal and infant health and providing family planning and reproductive health services.
Family planning relies, in part, on the communication skills and attitudes of healthcare providers involved in counseling. A study demonstrated that a client-centered approach to family planning counseling, which fosters shared decision-making, builds trust, and explores client preferences, increases satisfaction and retention. Another study suggests that midwifery students need more practical training in contraception and sexual health.
The use of printed educational materials is recommended to supplement and reinforce health information commonly delivered orally, thereby increasing the effectiveness of health education. According to Bernier, written educational materials offer a number of advantages, including message consistency, reusability, portability, distribution flexibility, information retention, and cost-effectiveness of production and updating. Healthcare professionals should provide written health education materials designed according to best-practice principles in written health education material design and focused on the healthy/ill individual. Health education materials are only effective if they are read, understood, and remembered by healthy/ill individuals.
By writing their own educational materials, health educators can adapt content to the policies, procedures, and equipment of their respective institutions, create answers to frequently asked questions by healthy and sick individuals, emphasize points deemed particularly important by healthcare professionals, and reinforce specific verbal instructions that clarify difficult concepts and address specific healthy and sick needs.
In this context, enhancing midwifery students' material development skills is crucial.
Standardized patients are individuals who have received special training to accurately convey a patient's story so accurately that even experienced healthcare professionals cannot distinguish them from real patients. By embodying all the physical and psychological characteristics of real patients, they provide students with a holistic understanding of patient care. These individuals are frequently used in health sciences education to promote the development of communication skills and other core competencies.
They can consistently represent a wide variety of scenarios. Issues such as high cost, standardized patient training, and other limitations limit the use of standardized patients in health education. A potential alternative to standardized patients is to have students role-play the patient. Peer simulation is an advanced form of role-playing in which students are trained to role-play clinical scenarios for their peers. While there are studies examining the impact of simulation on improving family planning counseling, no studies have been found comparing the effectiveness of standardized patient simulation with peer simulation.
In addition, this study focuses on the ability to prepare educational materials on the subject as well as family planning counseling.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were divided into three groups: standardized patient simulation, peer simulation, and control group.
| Arm | Type | Receives |
|---|---|---|
| Standardized Patient Group | Experimental | Behavioral: Standardized patient simulation practiceTrained with SP in simulation sessions |
| Peer Simulation Group | Experimental | Behavioral: Peer Simulation practiceTrained with a peer in simulation sessions |
| Control Group | No intervention | –No intervention was made |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Students taking the course for the first time
- Students who agree to participate in the research
- Students who continue the theoretical part of the course
Key exclusion criteria (1 listed)
- Students who did not attend simulation sessions
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 |
|---|---|---|
| Standardized patient simulation practiceCreating family planning scenarios Preparing educational materials Identifying and training standardized patients on the scenarios Providing family planning counseling with standardized patients in simulation sessions accompanied by educational materials | Behavioural | Standardized Patient Group |
| Peer Simulation practiceCreating family planning scenarios Preparing educational materials Identifying and training peers on the scenarios Providing family planning counseling in simulation sessions with peers using educational materials | Behavioural | Peer Simulation Group |
Primary outcome
State/Trait Anxiety Inventory
Time frame: Pre-simulation (Baseline) and Pre-family planning counseling
1. Not at all, 2. A little, 3. A lot, and 4) Completely
General Counseling Evaluation Form in Family Planning
Time frame: Throughout family planning counseling-10 minutes
"1 = needs improvement" (steps are implemented incorrectly or skipped), "2 = adequate" (steps are implemented correctly and in the correct order, but progress from step to step is not smooth), "3 = mastered" (steps are implemented correctly and in the correct order, and progress is smooth from step to step)
Patient Education Material Evaluation Tool
Time frame: Pre-family planning counseling- 5 minutes
Disagree = 0 points Agree = 1 point No Rating
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 24 Nov 2025.
- Background: PubMed 33218393Sharma KA, Zangmo R, Kumari A, Roy KK, Bharti J. Family planning and abortion services in COVID 19 pandemic. Taiwan J Obstet Gynecol. 2020 Nov;59(6):808-811. doi: 10.1016/j.tjog.2020.09.005. Epub 2020 Sep 10.
- Background: PubMed 24696891Ensuring Human Rights in the Provision of Contraceptive Information and Services: Guidance and Recommendations. Geneva: World Health Organization; 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK195054/
- BackgroundUnited Nations Population Fund (2023) Human Rights-Based Approach To Family Planning, UNFPA Support Tool. Available at: https://www.unfpa.org/sites/default/files/pub-pdf/UNFPA-HRBAtoFP-SupportTool-v231207.pdf Accessed:18 March 2025
- BackgroundŞimşek Çetinkaya, Ş., Gümüş Çalış, G., Kıbrıs, Ş., & Topal, M. (2024). Effectiveness of virtual patient simulation versus peer simulation in family planning training in midwifery students: a comparative educational intervention. Interactive Learning Environments, 32(3), 942-951.
- Background: PubMed 31722946Li Q, Rimon JG, Ahmed S. Capitalising on shared goals for family planning: a concordance assessment of two global initiatives using longitudinal statistical models. BMJ Open. 2019 Nov 12;9(11):e031425. doi: 10.1136/bmjopen-2019-031425.
- BackgroundInurreta-Díaz, M., Morales-Gual, Y. M., Aguilar-Vargas, E., Álvarez-Baeza, A., Magriñá-Lizama, J. S., Cetina-Sauri, G., & Méndez-Domínguez, N. (2021). Family-Planning counselling simulation for medical students: An exploratory educational intervention. Educación médica, 22, 271-276.
- Background: PubMed 28938374Schivone GB, Glish LL. Contraceptive counseling for continuation and satisfaction. Curr Opin Obstet Gynecol. 2017 Dec;29(6):443-448. doi: 10.1097/GCO.0000000000000408.
- Background: PubMed 24661469Walker SH, Davis G. Knowledge and reported confidence of final year midwifery students regarding giving advice on contraception and sexual health. Midwifery. 2014 May;30(5):e169-76. doi: 10.1016/j.midw.2014.02.002. Epub 2014 Feb 25.
- BackgroundSim, K. H. (2011). Tips for creating effective health education materials. The Journal of Korean Diabetes, 12(2), 99-103.
- Background: PubMed 15371031Hoffmann T, Worrall L. Designing effective written health education materials: considerations for health professionals. Disabil Rehabil. 2004 Oct 7;26(19):1166-73. doi: 10.1080/09638280410001724816.
- BackgroundHainsworth D. & Keyes K. Chapter 12: Instructional materials. In: Bastable SB. (ed.) Nurse as educator: Principles of teaching and learning for nursing practice, Fifth Edition Jones & Bartlett Learning; 2019. p 505-48.
- Background: PubMed 38807118Ghorbani B, Jackson AC, Dehghan-Nayeri N, Bahramnezhad F. Standardized patients' experience of participating in medical students' education: a qualitative content analysis. BMC Med Educ. 2024 May 28;24(1):586. doi: 10.1186/s12909-024-05531-x.
- Individual participant dataSharing planned: No
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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.
Döndü BATKIN ERTÜRK, Assist.Prof. principal investigator
Tokat Gaziosmanpaşa 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 Standardized patient simulation practice and Peer Simulation practice in people with Educational Problems, run by Tokat Gaziosmanpasa 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 3 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: finished, as of the sponsor's last update on 24 Nov 2025. 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?
State/Trait Anxiety Inventory (time frame: Pre-simulation (Baseline) and Pre-family planning counseling). 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?
On the ClinicalTrials.gov record for NCT07229183, which also lists 12 linked publications.
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 24 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.