NCT07229183

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

3 days

First QC Date

November 13, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

midwifery studentfamily planningpeer simulationstandardized patient simulationeducation material

Outcome Measures

Primary Outcomes (3)

  • State/Trait Anxiety Inventory

    1. Not at all, 2. A little, 3. A lot, and 4) Completely

    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)

    Throughout family planning counseling-10 minutes

  • Patient Education Material Evaluation Tool

    Disagree = 0 points Agree = 1 point No Rating

    Pre-family planning counseling- 5 minutes

Study Arms (3)

Standardized Patient Group

EXPERIMENTAL

Trained with SP in simulation sessions

Behavioral: Standardized patient simulation practice

Peer Simulation Group

EXPERIMENTAL

Trained with a peer in simulation sessions

Behavioral: Peer Simulation practice

Control Group

NO INTERVENTION

No intervention was made

Interventions

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

Standardized Patient Group

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

Peer Simulation Group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Students who did not attend simulation sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpaşa Üniversitesi

Tokat Province, Central, 60250, Turkey (Türkiye)

Location

Related Publications (12)

  • 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.

    PMID: 33218393BACKGROUND
  • 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/

    PMID: 24696891BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 31722946BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 28938374BACKGROUND
  • 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.

    PMID: 24661469BACKGROUND
  • Sim, K. H. (2011). Tips for creating effective health education materials. The Journal of Korean Diabetes, 12(2), 99-103.

    BACKGROUND
  • 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.

    PMID: 15371031BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 38807118BACKGROUND

Study Officials

  • Döndü BATKIN ERTÜRK, Assist.Prof.

    Tokat Gaziosmanpaşa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants were divided into three groups: standardized patient simulation, peer simulation, and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 14, 2025

Study Start

May 6, 2025

Primary Completion

May 9, 2025

Study Completion

May 28, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations