The Effect of Hand Sewing Practices on Suturing Skills

November 17, 2025 updated by: Melek Şen Aytekin

The Effect of Hand Sewing Practices on Suturing Skills in Midwifery Students.

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.).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Tokat Province
      • Tokat Province, Tokat Province, Turkey (Türkiye), 60000
        • Tokat Gaziosmanpaşa Üniversitesi
        • Sub-Investigator:
          • Ayşenur Kahraman, Research Assistant
        • Contact:
        • Principal Investigator:
          • Hatice Acar Bektaş, Assistant Professor
        • Sub-Investigator:
          • Zümrüt Yılar Erkek, Associate Professor
        • Sub-Investigator:
          • Melek Şen Aytekin, Research Assistant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard Education Group
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.
Experimental: Hand Sewing Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Structured Assessment of Technical Skills
Time Frame: 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).

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
Time Frame: 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).
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Personal Information Form
Time Frame: It is filled out as a pre-test 5 minutes after the standard training.
The Personal Information Form was prepared by the researcher in line with the literature to determine the socio-demographic characteristics of the students (age, education level, employment status, health insurance, parents' education status, parents' occupation, etc.). It consists of 10 questions.
It is filled out as a pre-test 5 minutes after the standard training.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Melek Şen Aytekin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GaziosmanpasaU-EBE-MŞA-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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