- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07229183
Family Planning Counseling and Simulation
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:
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Central
-
Tokat Province, Central, Turkey (Türkiye), 60250
- Tokat Gaziosmanpaşa Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Students who did not attend simulation sessions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
No intervention was made
|
|
|
Experimental: Standardized Patient Group
Trained with SP in simulation sessions
|
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
|
|
Experimental: Peer Simulation Group
Trained with a peer in simulation sessions
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State/Trait Anxiety Inventory
Time Frame: Pre-simulation (Baseline) and Pre-family planning counseling
|
|
Pre-simulation (Baseline) and Pre-family planning counseling
|
|
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) |
Throughout family planning counseling-10 minutes
|
|
Patient Education Material Evaluation Tool
Time Frame: Pre-family planning counseling- 5 minutes
|
Disagree = 0 points Agree = 1 point No Rating
|
Pre-family planning counseling- 5 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Döndü BATKIN ERTÜRK, Assist.Prof., Tokat Gaziosmanpasa University
Publications and helpful links
General 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.
- Ensuring 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/
- United 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.
- Inurreta-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.
- Walker 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.
- Sim, 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.
- Hainsworth 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TOKAT05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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