NCT07236853

Brief Summary

The overall aim of this study was to evaluate the effects of hand-held suture exercises on non-locking continuous suture skills used in episiotomy repair in midwifery students. The study, conducted with a randomized, single-blind, controlled design, aimed to generate evidence of psychomotor skill transfer using Objective Structured Assessment of Technical Skills based performance scores and secondary indicators (time, number of errors, etc.).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

November 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

September 30, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

midwifery educationSutureskill

Outcome Measures

Primary Outcomes (6)

  • Objective Structured Assessment of Technical Skills

    It will be used to assess simple running suture skills. The form will include a checklist and a global rating scale. Each general performance criterion is scored from 1 to 5. Each step includes ratings such as "Cannot do," "Can do with little assistance," and "Can do easily." Each scale is scored from 1 to 5. This means the total score can range from 4 to 20. High scores on the scale indicate a good level of general technical skill.

    All students will be asked to apply a simple running suture to the sponge after the intervention is completed. Evaluators will evaluate students using this form throughout the application (approximately 30 minutes).

  • Continue sutur skill evaluation form

    This form was created by researchers. It contains 10 items. The items are on a 3-point Likert-type scale, ranging from "performed" to "incorrect" or "incomplete." Participants receive 2 points for performing the skill, 1 point for incomplete performance, and 0 points for not performing or performing it incorrectly. The total score ranges from 0 to 20. Higher scores indicate successful implementation.

    The researchers will monitor and complete the student's application as they complete it. The application will take approximately 30 minutes to complete. Students will be monitored throughout the process using this form (approximately 30 minutes).

  • Episiotomy Skills Self-Efficacy Scale

    The Episiotomy Skills Self-Efficacy Scale (ESSES), developed by Hadımlı et al. (2023), was used to assess participants' self-efficacy perceptions regarding episiotomy application and repair. The scale consists of 17 items on a 5-point Likert-type scale (1 = Strongly disagree - 5 = Strongly agree). A two-factor structure (application and repair) was identified in the development study and was reported to explain 63.4% of the total variance. Turkish validity and reliability analyses were conducted within the scope of the same study, and the Cronbach's alpha coefficient was reported as 0.94.

    It will be used as a pre-test 5 minutes after the standard training. It will be used as a post-test 5 minutes after students practice the simple running suture.

  • Perceived Learning Scale

    The Perceived Learning Scale, developed by Rovai et al. (2009), was used to measure students' cognitive, affective, and psychomotor perceptions of learning. The scale was adapted into Turkish by Albayrak, Güngören, and Horzum (2014). The Turkish form consists of nine items, and items 2 and 7 are reverse-scored. The scale is scored on a 5-point Likert-type scale (1 = Strongly disagree - 5 = Strongly agree), with higher scores indicating a stronger perception of learning.

    It will be used as a pre-test 5 minutes after the standard training. It will be used as a post-test 5 minutes after students practice the simple running suture.

  • Clinical Skills Self-Efficacy Scale

    The Learning Self-Efficacy Scale for Clinical Skills (L-SES), developed by Bayazit, Gonullu, and Dogan (2022) and adapted to Turkish for validity and reliability, was used to assess self-efficacy perceptions related to clinical skills. The scale has a 14-item, single-factor structure and uses a 5-point Likert-type scoring system. The Turkish version's Cronbach's alpha was reported as 0.94.

    It will be used as a pre-test 5 minutes after the standard training. It will be used as a post-test 5 minutes after students practice the simple running suture.

  • State-Trait Anxiety Inventory

    The State-Trait Anxiety Inventory (STAI), developed by Spielberger et al. (1983), was used to measure participants' state and trait anxiety levels, along with a form adapted for Turkish by Öner and Le Compte (1985). Two subscales, each consisting of 20 items (STAI-1 = State Anxiety, STAI-2 = Trait Anxiety), are scored on a 4-point Likert-type scale. The total score is calculated by correcting for reverse items.

    It will be used as a pre-test 5 minutes after the standard training. It will be used as a post-test 5 minutes after students practice the simple running suture.

Other Outcomes (1)

  • Personal Information Form

    It is filled out as a pre-test 5 minutes after the standard training.

Study Arms (2)

Standard Education Group

NO INTERVENTION

This group received the standard training provided as part of the Normal Birth and Postpartum Period course. This training used an 80-slide PowerPoint presentation. The training was delivered in two 50-minute sessions. Surgical suture kits and sponges were used to demonstrate suturing skills.

Hand Sewing Group

EXPERIMENTAL

This group received the standard training provided as part of the Normal Birth and Postpartum Period course. An 80-slide PowerPoint presentation was used for this training. The training was delivered in two 50-minute sessions. Surgical suture kits and sponges were used to demonstrate suture skills. Following the standard training, this group received hand suture exercises. Students in this group received instruction in hand suture exercises. Hand suture exercises were practiced with the group for a total of four days, one day apart. Hand suture exercises were demonstrated using fabric, sponge, and paper. Straight stitching and basting techniques were demonstrated.

Other: Hand Sewing Group

Interventions

Students in this group will be trained in hand-sewing exercises and then be asked to work on sewing skills for one hour three days a week. Hand-sewing exercises will be demonstrated using fabric, sponge, and paper. Straight stitch and basting techniques will be demonstrated.

Hand Sewing Group

Eligibility Criteria

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

You may qualify if:

  • Volunteers participating in the study,
  • Those taking the Normal Birth and Postpartum Term course for the first time,
  • Those who have not received suture training before,
  • Third-year midwifery students

You may not qualify if:

  • Students who are absent on the day the course is taught.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tokat Gaziosmanpasa Üniversitesi

Tokat Province, Tokat Province, 60000, Turkey (Türkiye)

Location

Tokat Gaziosmanpasa Üniversitesi

Tokat Province, Tokat Province, 60000, Turkey (Türkiye)

Location

Central Study Contacts

Melek Şen Aytekin, Research Assistant Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In the study, one of the researchers will provide suture training to the Hand Sewing Group. The other three researchers will not know which student belongs to which group. After the first researcher completes the training, the other three researchers will assess the suture skills of both the Hand Sewing Group and the Standard Training Group using the Objective Structured Assessment of Technical Skill (OSATS). After the data collection process is complete, the data will be transferred to SPSS by the researcher. Once the data is transferred to SPSS, the Hand Sewing Group will be assigned a code of X, and the Standard Training Group will be assigned a code of Y. The statistical analyst will not know which code belongs to which group. After the analysis is complete, the codes will be assigned their own names, and the results will be evaluated.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 30, 2025

First Posted

November 19, 2025

Study Start

November 20, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations