NCT07344129

Brief Summary

There are significant shortcomings in current educational practices regarding midwives acquiring episiotomy skills. The acquisition of episiotomy skills by midwifery students begins in episiotomy skills laboratories. Students acquiring these skills in the laboratory involves being able to assess the indications for episiotomy and perform appropriate interventions based on the indication. Numerous intervention studies have been conducted on teaching episiotomy skills to students. In most of these studies, sponges, chickens, and cow tongues were preferred as simulators, and the effectiveness of the training was evaluated by applying different teaching methods. In addition to simulators used in episiotomy training, there are teaching methods used in midwifery clinical education, one of which is the paired learning model. This study was designed as a randomized controlled trial to evaluate the effect of the learning in pairs model in episiotomy training on episiotomy knowledge level, episiotomy self-efficacy, and state anxiety levels among midwifery students. The study will be conducted with a total of 92 midwifery students, divided into an intervention group (n=46) and a control group (n=46) (1:1 ratio). Data will be collected using the "Student Information Form," "Episiotomy Information Form," "Episiotomy Self-Efficacy Scale," and "State Anxiety Inventory" in pre-test and post-test formats. The research sample will consist of all students enrolled in the midwifery program and the Normal Birth and Postpartum Period course who agree to participate in the study. At the end of the study, it is expected that the effects of the learning in pairs (LiP) model on students' learning in episiotomy repair training will be explained. It is believed that the research results will contribute to midwifery education by enriching the methods used in midwifery students' education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

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

January 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

February 23, 2026

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

January 7, 2026

Last Update Submit

February 18, 2026

Conditions

Keywords

episiotomylearning in pairsmidwiferyself-afficacyanxiety

Outcome Measures

Primary Outcomes (3)

  • State Anxiety Inventory (STAI)

    The inventory consists of a total of 20 items. Ten items (items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20) in the state anxiety section are reverse-coded. The inventory is a 4-point Likert scale rated as "Not at all," "A little," "A lot," and "Completely." The total weighted score obtained for direct statements is calculated by subtracting the total weighted score of reverse statements and adding a fixed value (35 points) to this number. The total score ranges from 20 to 80. A high score on the inventory indicates a high level of anxiety, while a low score indicates a low level of anxiety.

    One hour before and immediately after the application

  • Episiotomy Self-Efficacy Scale

    The scale consists of a total of 17 items and four subscales (cognitive, emotional, motivational, and psychomotor). The scale is a 5-point Likert scale, and the ratings are (1) Strongly Disagree, (2) Somewhat Disagree, (3) Undecided, (4) Somewhat Agree, (5) Strongly Agree. There are no reverse-coded items on the scale. The lowest possible total score on the scale is 17, and the highest possible score is 85. High scores on the scale indicate high episiotomy self-efficacy. The Cronbach's Alpha reliability coefficient for the scale as a whole is reported as 0.955.

    One hour before and immediately after the application

  • Episiotomy Information Form

    This form consists of 25 statements (questions) designed to measure students' level of knowledge about episiotomy. Thirteen of these statements are true, and twelve are false. Participants are asked to respond with "True," "False," or "I don't know." Students' "True" responses to the statements will be scored as 1 point, while 'False' and "No opinion" responses will be scored as 0 points. The lowest possible score on the knowledge form is 0, and the highest possible score is 25.

    One hour before and immediately after the application

Study Arms (2)

Control group (application with calf tongue)

NO INTERVENTION

At Sakarya University Midwifery Department, episiotomy laboratory practice is routinely performed on calf tongues under instructor supervision as part of the Normal Birth and Postpartum Period course.Therefore, the group performing the practice on calf tongues has been accepted as the control group.The instructor will first provide theoretical training on episiotomy to the group arriving at the laboratory.The training content includes the importance of episiotomy, its risks, indications, contraindications, timing of episiotomy, materials used, types of episiotomy, episiotomy repair and timing, suture techniques, and midwifery care in episiotomy.Immediately after the training, episiotomy repair (suture techniques) will be practiced.Eight students will be accepted for the practice at the same time, and each student will sit at a single-person practice table.The instructor will try to pay attention to each student and will assist with suture techniques as long as the student requests it.

Experimental group (Application with learning in pairs)

EXPERIMENTAL

The instructor first provides the group arriving at the episiotomy laboratory with theoretical training on episiotomy,covering the importance of episiotomy,its risks, indications, contraindications, timing of episiotomy,materials used,types of episiotomy,episiotomy repair-timing, suture techniques,midwifery care in episiotomy.At the end of the theoretical training,they will watch videos related to suture techniques.After the training, they will proceed to the episiotomy repair(suture techniques) application.Students will be taken to the laboratory in pairs.A maximum of 4 pairs of students will be taken to the laboratory at the same time.The pairs will share the same table.Students will be instructed to begin episiotomy repair on a calf tongue in accordance with their episiotomy application knowledge and skills and to perform the repair procedure by supporting each other during the repair.Students are expected to repair the incision on the calf tongue separately in pairs.

Other: Application with learning in pairs

Interventions

Students will be taken to the laboratory in pairs. A maximum of 4 pairs of students will be taken to the laboratory at the same time. The pairs will share the same table. Students will be instructed to begin episiotomy repair on a calf tongue in accordance with their episiotomy application knowledge and skills and to perform the repair procedure by supporting each other during the repair. Students are expected to repair the incision on the calf tongue separately in pairs.

Experimental group (Application with learning in pairs)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Students who agree to participate in the study,
  • Students enrolled in the midwifery program,
  • Students enrolled in the Normal Birth and Postpartum Period course.

You may not qualify if:

  • Students who did not attend the theoretical part of the episiotomy course,
  • Students who did not attend the episiotomy laboratory course,
  • Students who have previously taken the Normal Birth and Postpartum Period course and have experience in episiotomy skills.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, Adapazarı, 00054, Turkey (Türkiye)

Location

Related Publications (14)

  • Yolcu B, Kaymak ZD, Turan Z, Baskaya YH. The episiotomy self-efficacy scale: a scale development study. BMC Nurs. 2025 Jul 17;24(1):931. doi: 10.1186/s12912-025-03578-9.

    PMID: 40676655BACKGROUND
  • Yılar Erkek, Z., & Öztürk Altınayak, S. (2021). The Effect of Simulation Teaching Technique on the Improvement of Episiotomy Performance Skills and State Anxiety of Midwifery Students in Turkey: RCT. Clinical Simulation in Nursing, 54, 62-69. https://doi.org/10.1016/j.ecns.2021.01.014

    BACKGROUND
  • Widarsson M, Velandia M, Pellfolk MG, Kerstis B. Learning in pairs in Swedish delivery wards: A win-win approach for midwifery preceptors and students. Midwifery. 2025 Dec;151:104632. doi: 10.1016/j.midw.2025.104632. Epub 2025 Oct 11.

    PMID: 41124872BACKGROUND
  • Webb SS, Skene ER, Manresa M, Percy EK, Freeman RM, Tincello DG. Evaluation of midwifery pelvic floor education and Training across the UK and Spain. Eur J Obstet Gynecol Reprod Biol. 2021 Jan;256:140-144. doi: 10.1016/j.ejogrb.2020.10.065. Epub 2020 Nov 5.

    PMID: 33227686BACKGROUND
  • Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P., & Jacobs, G. (1983). State-Trait Anxiety Inventory For Adults . Consulting Psychologists Press, Palo Alto, CA.

    BACKGROUND
  • Şen Aytekin, M., Kahraman, A., & Alparslan, Ö. (2022). Ebelik Öğrencilerine Epizyotomi Öğretmeye Yönelik Kullanılan Simülasyon Yöntemlerinin Etkisi: Sistematik Derleme. J TOGU Heal Sci, 2(2), 212-224.

    BACKGROUND
  • Öner, N., & Le Compte, A. (1983). State-trait anxiety inventory handbook. Boğaziçi University Publications, 333, 1-26.

    BACKGROUND
  • Hill R, Woodward M, Arthur A. Collaborative Learning in Practice (CLIP): Evaluation of a new approach to clinical learning. Nurse Educ Today. 2020 Feb;85:104295. doi: 10.1016/j.nedt.2019.104295. Epub 2019 Nov 21.

    PMID: 31783268BACKGROUND
  • Gould J, Webb SS, Byrne C, Brace E, Cleary J, Dow L, Edwards E, Glyn-Jones E, Hunter T, Longton J, Tibble K, MacLellan J. Red flags for episiotomy in a midwife-led birth: Using co-production with midwives to capture clinical experience. Women Birth. 2023 Mar;36(2):217-223. doi: 10.1016/j.wombi.2022.06.009. Epub 2022 Aug 6.

    PMID: 35941059BACKGROUND
  • Gönenç, İ. M., Aker, M. N., & Alan Dikmen, H. (2025). The Effect of Chicken Model on Satisfaction, Self-Confidence, and Anxiety in Teaching Episiotomy Repair: A Randomized Controlled Trial. Turkiye Klinikleri Journal of Health Sciences, 10(3), 647-657. https://doi.org/10.5336/healthsci.2025-108536

    BACKGROUND
  • Ghulmiyyah L, Sinno S, Mirza F, Finianos E, Nassar AH. Episiotomy: history, present and future - a review. J Matern Fetal Neonatal Med. 2022 Apr;35(7):1386-1391. doi: 10.1080/14767058.2020.1755647. Epub 2020 Apr 26.

    PMID: 32338105BACKGROUND
  • Faithfull-Byrne, A., Thompson, L., Schafer, K. W., Elks, M., Jaspers, J., Welch, A., Williamson, M., Cross, W., & Moss, C. (2017). Clinical coaches in nursing and midwifery practice: Facilitating point of care workplace learning and development. Collegian, 24(4), 403-410. https://doi.org/10.1016/j.colegn.2016.06.001

    BACKGROUND
  • Demirel, G., Evcili, F., Kaya, N., & Doganer, A. (2020). The Effect of Episiotomy Repair Simulation on the Anxiety and Self-Efficacy levels of Midwifery Students. Journal of Midwifery and Reproductive Health, 8(1), 2050-2057. https://doi.org/10.22038/jmrh.2019.42024.1479

    BACKGROUND
  • Ahmed M, Kaur I, Thota S. Changing minds: The impact of introducing evidence-based practices around the use of episiotomy in a South Indian Tertiary Centre. Midwifery. 2023 Nov;126:103833. doi: 10.1016/j.midw.2023.103833. Epub 2023 Sep 25.

    PMID: 37801839BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Yasemin Hamlacı

    Sakarya University Department of Midwifery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The control group will undergo episiotomy in the cow tongue group. The learning group will undergo episiotomy in pairs.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The control group will undergo episiotomy in the cow tongue group. The learning group will undergo episiotomy in pairs.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 15, 2026

Study Start

January 1, 2026

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

February 23, 2026

Record last verified: 2025-12

Locations