Midwifery EducationNCT07236853
The Effect of Hand Sewing Practices on Suturing Skills
A study testing Hand Sewing Group in people with Midwifery Education and Suture, run by Melek Şen Aytekin at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Midwifery Education, Suture, Skill Performance
- What is being tested?
- Hand Sewing Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Nov 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Students who are absent on the day the course is taught.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Tokat Gaziosmanpasa Üniversitesi
Tokat Province, Tokat Province, 60000
Melek Aytekin, Research Assistant Doctor, +90 5071616044, meleksenaytekin@gmail.com
Tokat Gaziosmanpasa Üniversitesi
Tokat Province, Tokat Province, 60000
melek aytekin, 05071616044, mlksn90@gmail.com
Hatice Acar Bektaş, Assistant Professor
About this study
Official title: 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.).
- Conditions
- Midwifery Education, Suture, Skill Performance
- Being tested
- Hand Sewing Group
- Keywords
- midwifery education, Suture, skill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Sewing GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Hand Sewing Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midwifery EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melek Şen Aytekin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melek Şen Aytekin, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236853
- Sponsor's protocol ID
- GaziosmanpasaU-EBE-MŞA-02
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Sewing Practices on Suturing Skills in Midwifery Students.
- ClinicalTrials.gov ID
- NCT07236853
- Acronym / sponsor ID
- GaziosmanpasaU-EBE-MŞA-02
- Conditions
- Midwifery Education, Suture, Skill Performance
- Keywords
- midwifery education, Suture, skill
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Melek Şen AytekinUniversity, hospital or other
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Hand Sewing GroupThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Students who are absent on the day the course is taught.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand Sewing GroupStudents 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. | Other | Hand Sewing Group |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Sewing Group in people with Midwifery Education and Suture, run by Melek Şen Aytekin at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melek Şen Aytekin, Research Assistant Doctor (+905071616044, meleksenaytekin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.