- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07236853
The Effect of Hand Sewing Practices on Suturing Skills
The Effect of Hand Sewing Practices on Suturing Skills in Midwifery Students.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Melek Şen Aytekin, Research Assistant Doctor
- Phone Number: +905071616044
- Email: meleksenaytekin@gmail.com
Study Locations
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Tokat Province
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Tokat Province, Tokat Province, Turkey (Türkiye), 60000
- Tokat Gaziosmanpaşa Üniversitesi
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Sub-Investigator:
- Ayşenur Kahraman, Research Assistant
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Contact:
- melek aytekin
- Phone Number: 05071616044
- Email: mlksn90@gmail.com
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Principal Investigator:
- Hatice Acar Bektaş, Assistant Professor
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Sub-Investigator:
- Zümrüt Yılar Erkek, Associate Professor
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Sub-Investigator:
- Melek Şen Aytekin, Research Assistant
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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|
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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.
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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
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).
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Other Outcome Measures
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.
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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.
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It is filled out as a pre-test 5 minutes after the standard training.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- GaziosmanpasaU-EBE-MŞA-02
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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