EpisiotomyEpisiotomyNCT06415877
The Effect of the Modified Simulation Model on Self-Efficacy, Anxiety, and Academic Motivation in Episiotomy Training
A study testing Episio Training in people with Episiotomy and Anxiety, run by Emine Yıldırım.
Trial summary
It was planned as a randomized controlled study to determine the effect of the modified simulation model on self-efficacy, anxiety and academic motivation in episiotomy training. It will be held online with students from the midwifery department of Osmaniye Korkut Ata University. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy, Anxiety, Simulation
- What is being tested?
- Episio Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2024to 30 Jun 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
- Midwifery student
- volunteers
Who cannot join
- involuntary
About this study
It was planned as a randomized controlled study to determine the effect of the modified simulation model on self-efficacy, anxiety and academic motivation in episiotomy training. It will be held online with students from the midwifery department of Osmaniye Korkut Ata University.
- Conditions
- Episiotomy, Anxiety, Simulation
- Being tested
- Episio Training
- Keywords
- episiotomy, anxiety, simulation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episio TrainingOther
episio repair training
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | beef tongue stitched Receives: Other: Episio Training |
| sham comparator | Sham comparator | episio model Receives: Other: Episio Training |
| experimental group | Experimental | modified tripe coated veal Receives: Other: Episio Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-efficacy
questionnaire
Measured: 1 week
Secondary outcomes (1)
academic motivation
questionnaire
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start30 May 2024 (estimated)
- Primary completion20 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpisiotomyStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emine Yıldırım
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emine Yıldırım, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415877
- Sponsor's protocol ID
- 1111111
- Acronym
- Episiotomy
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Modified Simulation Model on Self-Efficacy, Anxiety, and Academic Motivation in Episiotomy Training
- ClinicalTrials.gov ID
- NCT06415877
- Acronym / sponsor ID
- Episiotomy / 1111111
- Conditions
- Episiotomy, Anxiety, Simulation
- Keywords
- episiotomy, anxiety, simulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Emine YıldırımUniversity, hospital or other
- Study start
- 30 May 2024 (estimated)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 16 May 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.
It was planned as a randomized controlled study to determine the effect of the modified simulation model on self-efficacy, anxiety and academic motivation in episiotomy training. It will be held online with students from the midwifery department of Osmaniye Korkut Ata University.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: Episio Trainingbeef tongue stitched |
| sham comparator | Sham comparator | Other: Episio Trainingepisio model |
| experimental group | Experimental | Other: Episio Trainingmodified tripe coated veal |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Midwifery student
- volunteers
Key exclusion criteria (1 listed)
- involuntary
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 |
|---|---|---|
| Episio Trainingepisio repair training | Other | experimental group, placebo, sham comparator |
Primary outcome
self-efficacy
Time frame: 1 week
questionnaire
1 secondary outcome
academic motivation
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Episio Training in people with Episiotomy and Anxiety, run by Emine Yıldırım.
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 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: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
self-efficacy (time frame: 1 week). 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 16 May 2024.