Training Group, SensitivityNCT06283537
Online Episiotomy Simulation Training for Midwifery Students
A study testing Effect of training method in people with Training Group, Sensitivity, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: To determine the effect of online episiotomy simulation training to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence. Method: This study is a randomized controlled experimental study. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Training Group, Sensitivity
- What is being tested?
- Effect of training method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2024to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Wanting to participate in the study voluntarily
- Having taken the normal birth and postpartum period course
- Not having any previous episiotomy experience
Who cannot join
- Student wants to leave the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Online Episiotomy Simulation Training on Midwifery Students' Episiotomy Skill Performances, Satisfaction With the Teaching Method and Self-Confidence
Purpose: To determine the effect of online episiotomy simulation training to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence.
Method: This study is a randomized controlled experimental study. It will be conducted with third-year students studying at Kastamonu University Midwifery Department in the 2023-2024 period. In the research, all third-year students in the midwifery department (n=60) will be divided into 30 students into the online education group and 30 students into the face-to-face education group using a random sampling model. "Student Information Form", "Episiotomy Skill Evaluation Form" and "Student Satisfaction and Self-Confidence in Learning Scale" will be used to collect data.
Read the detailed description
Episiotomy is the most commonly performed obstetric surgical procedure in obstetrics clinics. Failure to perform the procedure correctly may cause psychological and physiological problems in women. It is of great importance that midwives who are responsible for this practice receive training to acquire the necessary knowledge and skills. Midwifery students are expected to have sufficient skills in episiotomy practice before graduation. Teaching episiotomy practice is one of the basic skills taught face-to-face with simulation support. However, with the emergency distance education system implemented due to sudden decisions made in education and training after extraordinary situations such as pandemics and earthquakes, many theoretical and skill trainings had to be done online. It is not possible to predict whether similar extraordinary situations will occur again in the future. For this reason, it is considered important to evaluate the effect of online training on an important skill such as episiotomy application on students' episiotomy performance skills and their satisfaction with this training method and their self-confidence.
This study will be conducted to determine the effect of online episiotomy simulation training to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence.
This study is a randomized controlled experimental study. It will be conducted with third-year students studying at Kastamonu University Midwifery Department in the 2023-2024 period. In the study, all 3rd year midwifery undergraduate students (n=60) taking the Normal Birth and Post-Care course will be included. 30 students will be allocated to the online education group and 30 students to the face-to-face education group using a random sampling model. To the online education group; Online episiotomy simulation training will be provided, while the face-to-face training group will be given face-to-face episiotomy simulation training in the traditionally applied school environment.
After all students in the face-to-face education and online education groups complete their applications, the students will practice on the material one by one in the school environment and will be evaluated through the Episiotomy Skill Evaluation Form. In the evaluation, a blinding technique will be used to prevent the person conducting the study interventions from making an evaluation in favor of the intervention group. For this purpose, the faculty member conducting the research initiatives will not take part in the evaluation, instead the evaluation will be made by two different field experts. The experts to be consulted for the evaluation will consist of people working as academicians in the field of obstetrics, nursing and midwifery. After the evaluation, students will have to fill out the survey (Student Information Form) and scale (Student Satisfaction and Self-Confidence in Learning Scale).
- Conditions
- Training Group, Sensitivity
- Being tested
- Effect of training method
- Keywords
- Episiotomy, Online Education, Simulation, Midwifery
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of training methodOther
The effect of the training method given to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence.
| Study group | Role | What they receive |
|---|---|---|
| Online episiotomy group | Experimental | 30 students will be assigned to the online education group with a random sampling model. To this group; Online episiotomy simulation training will be provided. Receives: Other: Effect of training method |
| Face to face training group | Experimental | 30 students will be assigned to the face-to-face education group with a random sampling model. This group will be given face-to-face episiotomy simulation training in the school environment, which is traditionally applied to the face-to-face training group.. Receives: Other: Effect of training method |
What is being measured
The primary outcome is the main question the study is designed to answer.
episiotomy skill performances
Is there a difference in episiotomy skill performance between midwifery students receiving online episiotomy simulation training and face-to-face episiotomy simulation training?Episiotomy skill performances will be evaluated with the "Episiotomy Skill Evaluation Form". Possible scores range from 0 to 100, with higher scores indicating higher performance for episiotomy skills. High scores indicate "high skill performance" and low scores indicate "low skill performance."
Measured: 4 weeks
Secondary outcomes (1)
Satisfaction with education
What is the satisfaction of midwifery students who receive episiotomy simulation training and face-to-face episiotomy simulation training? "Student Satisfaction and Self-Confidence in Learning scale" will be used in the evaluation. The minimum score obtained from the scale is 17 and the highest score is 61. A high score indicates high satisfaction and self-confidence.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start16 Feb 2024
- Primary completion8 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Training Group, SensitivityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A comparative randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihal Aydin, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283537
- Sponsor's protocol ID
- KÜBAP-01/2023-39
- Status last verified
- Mar 2025
- First submitted
- 16 Feb 2024
- Last updated
- 7 Mar 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 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Online Episiotomy Simulation Training on Midwifery Students' Episiotomy Skill Performances, Satisfaction With the Teaching Method and Self-Confidence
- ClinicalTrials.gov ID
- NCT06283537
- Acronym / sponsor ID
- KÜBAP-01/2023-39
- Conditions
- Training Group, Sensitivity
- Keywords
- Episiotomy, Online Education, Simulation, Midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 28 Feb 2024 (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.
Purpose: To determine the effect of online episiotomy simulation training to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence.
Method: This study is a randomized controlled experimental study. It will be conducted with third-year students studying at Kastamonu University Midwifery Department in the 2023-2024 period. In the research, all third-year students in the midwifery department (n=60) will be divided into 30 students into the online education group and 30 students into the face-to-face education group using a random sampling model. "Student Information Form", "Episiotomy Skill Evaluation Form" and "Student Satisfaction and Self-Confidence in Learning Scale" will be used to collect data.
Detailed description
Episiotomy is the most commonly performed obstetric surgical procedure in obstetrics clinics. Failure to perform the procedure correctly may cause psychological and physiological problems in women. It is of great importance that midwives who are responsible for this practice receive training to acquire the necessary knowledge and skills. Midwifery students are expected to have sufficient skills in episiotomy practice before graduation. Teaching episiotomy practice is one of the basic skills taught face-to-face with simulation support. However, with the emergency distance education system implemented due to sudden decisions made in education and training after extraordinary situations such as pandemics and earthquakes, many theoretical and skill trainings had to be done online. It is not possible to predict whether similar extraordinary situations will occur again in the future. For this reason, it is considered important to evaluate the effect of online training on an important skill such as episiotomy application on students' episiotomy performance skills and their satisfaction with this training method and their self-confidence.
This study will be conducted to determine the effect of online episiotomy simulation training to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence.
This study is a randomized controlled experimental study. It will be conducted with third-year students studying at Kastamonu University Midwifery Department in the 2023-2024 period. In the study, all 3rd year midwifery undergraduate students (n=60) taking the Normal Birth and Post-Care course will be included. 30 students will be allocated to the online education group and 30 students to the face-to-face education group using a random sampling model. To the online education group; Online episiotomy simulation training will be provided, while the face-to-face training group will be given face-to-face episiotomy simulation training in the traditionally applied school environment.
After all students in the face-to-face education and online education groups complete their applications, the students will practice on the material one by one in the school environment and will be evaluated through the Episiotomy Skill Evaluation Form. In the evaluation, a blinding technique will be used to prevent the person conducting the study interventions from making an evaluation in favor of the intervention group. For this purpose, the faculty member conducting the research initiatives will not take part in the evaluation, instead the evaluation will be made by two different field experts. The experts to be consulted for the evaluation will consist of people working as academicians in the field of obstetrics, nursing and midwifery. After the evaluation, students will have to fill out the survey (Student Information Form) and scale (Student Satisfaction and Self-Confidence in Learning Scale).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A comparative randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Online episiotomy group | Experimental | Other: Effect of training method30 students will be assigned to the online education group with a random sampling model. To this group; Online episiotomy simulation training will be provided. |
| Face to face training group | Experimental | Other: Effect of training method30 students will be assigned to the face-to-face education group with a random sampling model. This group will be given face-to-face episiotomy simulation training in the school environment, which is traditionally applied to the face-to-face training group.. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Wanting to participate in the study voluntarily
- Having taken the normal birth and postpartum period course
- Not having any previous episiotomy experience
Key exclusion criteria (1 listed)
- Student wants to leave the study
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 |
|---|---|---|
| Effect of training methodThe effect of the training method given to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence. | Other | Face to face training group, Online episiotomy group |
Primary outcome
episiotomy skill performances
Time frame: 4 weeks
Is there a difference in episiotomy skill performance between midwifery students receiving online episiotomy simulation training and face-to-face episiotomy simulation training?Episiotomy skill performances will be evaluated with the "Episiotomy Skill Evaluation Form". Possible scores range from 0 to 100, with higher scores indicating higher performance for episiotomy skills. High scores indicate "high skill performance" and low scores indicate "low skill performance."
1 secondary outcome
Satisfaction with education
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of training method in people with Training Group, Sensitivity, run by Kastamonu University at 1 site 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 3 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: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
episiotomy skill performances (time frame: 4 weeks). 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 7 Mar 2025.