Episiotomy WoundNCT05502640
Chicken Model in Teaching Episiotomy Repair
A study testing Education model and Routine Education model in people with Episiotomy Wound, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of chicken use in episiotomy repair training of midwifery students on students' satisfaction, self-confidence and anxiety levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Episiotomy Wound
- What is being tested?
- Education model and Routine Education model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 31 Dec 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Midwifery students who were registered in the midwifery department in the 2020-2021 academic year and take childbearing course,
- Students over the age of 18
Who cannot join
- Having previously received training on episiotomy and its repair,
- Students who fill in the data collection forms incompletely will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Nursing
Ankara, 06230
About this study
Official title: The Effect of Chicken Model in Teaching Episiotomy Repair on Satisfaction, Self-Confidence, and Anxiety Levels of Midwifery Students
The aim of this study is to determine the effect of chicken use in episiotomy repair training of midwifery students on students' satisfaction, self-confidence and anxiety levels.
Hypotheses H01 There is no difference between the satisfaction score of the chicken group and the satisfaction score of the control group in episiotomy repair training.
H02 In episiotomy repair training, there is no difference between the self-confidence score of the chicken group and the self-confidence score of the control group.
H03 There is no difference between the anxiety score of the chicken group and the anxiety score of the control group in episiotomy repair training.
- Conditions
- Episiotomy Wound
- Being tested
- Education model, Routine Education model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education modelOther
Chicken legs will be used for each student in the study. Intermittent and continuous suture techniques will be studied on the incision made on the chicken leg.
Routine Education modelOther
Also called Sponge Group
In the study, 15 cm x 20 cm sponge will be used for each student. Intermittent and continuous suture techniques will be practiced on the sponge.
| Study group | Role | What they receive |
|---|---|---|
| sponge group | Other | Control group Receives: Other: Routine Education model |
| Chicken group | Experimental | Not described Receives: Other: Education model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The State-Trait Anxiety Inventory (STAI)
The inventory was developed by Spielberger et al. in 1970. An adaptation, validity, and reliability study of the State-Trait Anxiety Scale in Turkish was conducted by Oner and Le Compte in 1983. The scale consists of two subdimensions: the state anxiety has 20 items and is used to determine what is felt at a specific moment under certain conditions, and the trait anxiety has 20 items and is used to determine what has been felt in the last 7 days. High scores from each subscale indicate a high level of anxiety.
STAI-S consist of 20 items with four points Likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.
Measured: immediately before the training, immediately after the training and immediately after the clinical practice.
Change in satisfaction
Visual Analog Scale is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfaction and a score of 0 pointed to no satisfaction.
Measured: immediately before the training, immediately after the training and immediately after the clinical practice.
Self-Sufficiency
Visual Analog Scale (VAS)- assessed by adequate vision. For each item, students rated their sense of self-sufficiency on a scale of 0 (very inadequate) to 10 (very adequate).
Measured: immediately before the training, immediately after the training and immediately after the clinical practice.
The Student Satisfaction and Self-Confidence in Learning Scale
This instrument is a 13-item scale used to measure student satisfaction with the simulation activity (5 items) and self-confidence in learning (8 items). Responses are rated on a 5-point Likert scale with values ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher satisfaction and greater levels of self confidence.
Measured: immediately after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start15 Sep 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy WoundStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur Münevver Gönenç, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502640
- Sponsor's protocol ID
- 289
- Status last verified
- May 2023
- First submitted
- 25 Apr 2022
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chicken Model in Teaching Episiotomy Repair on Satisfaction, Self-Confidence, and Anxiety Levels of Midwifery Students
- ClinicalTrials.gov ID
- NCT05502640
- Acronym / sponsor ID
- 289
- Conditions
- Episiotomy Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Aug 2022 (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 aim of this study is to determine the effect of chicken use in episiotomy repair training of midwifery students on students' satisfaction, self-confidence and anxiety levels.
Hypotheses H01 There is no difference between the satisfaction score of the chicken group and the satisfaction score of the control group in episiotomy repair training.
H02 In episiotomy repair training, there is no difference between the self-confidence score of the chicken group and the self-confidence score of the control group.
H03 There is no difference between the anxiety score of the chicken group and the anxiety score of the control group in episiotomy repair training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sponge group | Other | Other: Routine Education modelControl group |
| Chicken group | Experimental | Other: Education model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Midwifery students who were registered in the midwifery department in the 2020-2021 academic year and take childbearing course,
- Students over the age of 18
Key exclusion criteria (2 listed)
- Having previously received training on episiotomy and its repair,
- Students who fill in the data collection forms incompletely will not be included in 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 |
|---|---|---|
| Education modelChicken legs will be used for each student in the study. Intermittent and continuous suture techniques will be studied on the incision made on the chicken leg. | Other | Chicken group |
| Routine Education modelAlso: Sponge GroupIn the study, 15 cm x 20 cm sponge will be used for each student. Intermittent and continuous suture techniques will be practiced on the sponge. | Other | sponge group |
Primary outcome
Change in The State-Trait Anxiety Inventory (STAI)
Time frame: immediately before the training, immediately after the training and immediately after the clinical practice.
The inventory was developed by Spielberger et al. in 1970. An adaptation, validity, and reliability study of the State-Trait Anxiety Scale in Turkish was conducted by Oner and Le Compte in 1983. The scale consists of two subdimensions: the state anxiety has 20 items and is used to determine what is felt at a specific moment under certain conditions, and the trait anxiety has 20 items and is used to determine what has been felt in the last 7 days. High scores from each subscale indicate a high level of anxiety. STAI-S consist of 20 items with four points Likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.
Change in satisfaction
Time frame: immediately before the training, immediately after the training and immediately after the clinical practice.
Visual Analog Scale is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfaction and a score of 0 pointed to no satisfaction.
Self-Sufficiency
Time frame: immediately before the training, immediately after the training and immediately after the clinical practice.
Visual Analog Scale (VAS)- assessed by adequate vision. For each item, students rated their sense of self-sufficiency on a scale of 0 (very inadequate) to 10 (very adequate).
The Student Satisfaction and Self-Confidence in Learning Scale
Time frame: immediately after training
This instrument is a 13-item scale used to measure student satisfaction with the simulation activity (5 items) and self-confidence in learning (8 items). Responses are rated on a 5-point Likert scale with values ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher satisfaction and greater levels of self confidence.
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 19 May 2023.
- Individual participant dataSharing planned: Undecided
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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 Education model and Routine Education model in people with Episiotomy Wound, run by Ankara 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 2 inclusion and 2 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 19 May 2023. 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?
Change in The State-Trait Anxiety Inventory (STAI) (time frame: immediately before the training, immediately after the training and immediately after the clinical practice.). The study lists 4 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 May 2023.