- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06930001
Etamine Processing on Episiotomy Repair Skills, Stress and Learning Attitudes in Midwifery Students
Effect of Etamine Processing on Midwifery Students' Episiotomy Repair Application Ability, Perceived Stress and Learning Attitude: Randomized Controlled Study
Research Hypotheses H1: Midwifery students who practice Etamine have higher episiotomy repair skills than those who do not.
H2: Midwifery students who practice Etamine have lower perceived stress levels than those who do not.
H3: Midwifery students who practice Etamine have higher learning attitudes than those who do not.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selçuklu
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Konya, Selçuklu, Turkey (Türkiye), 42130
- Selcuk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The inclusion criteria for the study include students who are willing to participate in the study and who do not have any learning or working experience related to episiotomy repair.
Exclusion Criteria:
- Students with diagnosable diseases affecting their learning ability, those who have had accidents during the training and assessment sessions, and foreign nationals will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Etamine Application Group /Intervention
Before the intervention, eligible midwifery students who agreed to participate were informed verbally and in writing, and completed the Informed Consent Form, The Participant Information Form, Perceived Stress Scale, and Scale of Attitudes Towards Learning (pre-test). Forms were distributed by a department assistant not involved in the study. During the first two weeks, students in the intervention group received individual 45-minute etamine (cross-stitch) training in the clinical skills laboratory, including introduction to materials and basic techniques, followed by practice of simple patterns. Students continued etamine practice for six weeks (12 sessions, 45 minutes each). Six weeks later, all students received episiotomy education (2-hour theory by the researcher and 6-hour practical training by two independent instructors). Students practiced suturing on a model and were evaluated |
Before the intervention, eligible midwifery students who agreed to participate were informed verbally and in writing, and completed the Informed Consent Form, The Participant Information Form, Perceived Stress Scale, and Scale of Attitudes Towards Learning (pre-test).
Forms were distributed by a department assistant not involved in the study.
During the first two weeks, students in the intervention group received individual 45-minute etamine (cross-stitch) training in the clinical skills laboratory, including introduction to materials and basic techniques, followed by practice of simple patterns.
Students continued etamine practice for six weeks (12 sessions, 45 minutes each).
Six weeks later, all students received episiotomy education (2-hour theory by the researcher and 6-hour practical training by two independent instructors).
Students practiced suturing on a model and were evaluated
|
|
No Intervention: Control
Control group students completed the Informed Consent Form, The Participant Information Form, Perceived Stress Scale, and Scale of Attitudes Towards Learning (pre-test) distributed by a department assistant not involved in the study, while the researcher was absent.
Students did not receive etamine training.
Six weeks later, all students received 2-hour theory and 6-hour practical episiotomy training by the researcher and two independent instructors.
Groups of ~20 students received 1-hour suturing training, then practiced and were assessed in separate rooms by blinded instructors using the Episiotomy Repair Skill Form (post-test).
Final evaluations included the Perceived Stress Scale and Scale of Attitudes Towards Learning (post-test).
After the study, etamine training was optionally offered to ensure equal skill opportunities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Episiotomy Repair Skill Form
Time Frame: Fifth week after the start of the application
|
The form, which was developed by the researcher by scanning the literature and obtaining expert opinions, consists of 16 questions.
It will be evaluated under four headings.
It consists of "Selection and use of suture material (3 questions)", "Suture Technique and Application (8 questions)", "Equal and Proper Placement of Sutures (2 questions)", "Aesthetic and Functional Results (3 questions)".
The steps in the skill form were examined by midwifery faculty members who are experts in the field and finalized.
The evaluation form includes the following options: "1.
Needs improvement: The step is not applied at all, applied incorrectly or not applied in order, 2. Sufficient: The step is applied correctly and in order, but there are deficiencies and/or the help of the trainer is needed, 3. Mastered: The step is applied correctly and in order without pausing and needing help."
High scores obtained from the form indicate good skill.
|
Fifth week after the start of the application
|
|
Perceived Stress Scale
Time Frame: pre-intervention
|
The Perceived Stress Scale (PSS-10), developed by Cohen et al. (1983) and adapted to Turkish by Kaya et al. (2019), consists of 10 items rated on a five-point Likert scale (0-4).
Items 4, 5, 7, and 8 are reverse-scored.
Scores of 0-13 indicate low, 14-26 moderate, and 27-40 high stress.
Cronbach's alpha for self-efficacy and helplessness subscales were 0.68 and 0.85, respectively.
The scale was used to assess how stress in the lab setting affects students' skill performance and reflects clinical stress.
The lab is a preparatory stage for clinical practice, making stress measurement here significant.
Literature shows that lab stress can impact students' skills (Duffy et al., 2021), and tasks requiring fine motor skills like etamine may also influence stress in competitive environments (Ferrara, 2022).
Therefore, the PSS will evaluate both lab stress and etamine's impact, contributing valuable insights into skill performance and preparedness.
|
pre-intervention
|
|
Attitude Scale Towards Learning
Time Frame: pre-intervention
|
The scale was developed by Kara (2010) to measure students' attitudes towards learning.
It includes 40 items and four sub-dimensions: Nature of Learning (7 items), Anxiety About Learning (13 items), Expectations About Learning (9 items), and Openness to Learning (11 items).
It uses a 5-point Likert scale: 1 (Strongly Disagree) to 5 (Strongly Agree).
Subscale score ranges are: Nature of Learning (7-35), Anxiety (13-65), Expectations (9-45), and Openness (11-55).
The scale provides insights into how students perceive and approach learning.
Cronbach's alpha was calculated as 0.73, indicating acceptable reliability (Kara, 2010).
It is suitable for assessing both positive and negative attitudes related to the learning process in educational research.
|
pre-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale
Time Frame: Fifth week after the start of the application
|
The Perceived Stress Scale (PSS-10), developed by Cohen et al. (1983) and adapted to Turkish by Kaya et al. (2019), consists of 10 items rated on a five-point Likert scale (0-4).
Items 4, 5, 7, and 8 are reverse-scored.
Scores of 0-13 indicate low, 14-26 moderate, and 27-40 high stress.
Cronbach's alpha for self-efficacy and helplessness subscales were 0.68 and 0.85, respectively.
The scale was used to assess how stress in the lab setting affects students' skill performance and reflects clinical stress.
The lab is a preparatory stage for clinical practice, making stress measurement here significant.
Literature shows that lab stress can impact students' skills (Duffy et al., 2021), and tasks requiring fine motor skills like etamine may also influence stress in competitive environments (Ferrara, 2022).
Therefore, the PSS will evaluate both lab stress and etamine's impact, contributing valuable insights into skill performance and preparedness.
|
Fifth week after the start of the application
|
|
Attitude Scale Towards Learning
Time Frame: Fifth week after the start of the application
|
The scale was developed by Kara (2010) to measure students' attitudes towards learning.
It includes 40 items and four sub-dimensions: Nature of Learning (7 items), Anxiety About Learning (13 items), Expectations About Learning (9 items), and Openness to Learning (11 items).
It uses a 5-point Likert scale: 1 (Strongly Disagree) to 5 (Strongly Agree).
Subscale score ranges are: Nature of Learning (7-35), Anxiety (13-65), Expectations (9-45), and Openness (11-55).
The scale provides insights into how students perceive and approach learning.
Cronbach's alpha was calculated as 0.73, indicating acceptable reliability (Kara, 2010).
It is suitable for assessing both positive and negative attitudes related to the learning process in educational research.
|
Fifth week after the start of the application
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1234567891
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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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