Episiotomy WoundNCT06348680
The Effect of Video-assisted Episiotomy Repair Training on Anxiety and Self-efficacy Levels in Midwifery Students
A study testing Video assisted episiotomy repair training in people with Episiotomy Wound, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
The goal of midwifery undergraduate education is; To provide students with basic professional knowledge, skills and attitudes in cognitive, affective and psychomotor dimensions. Various practices are used to provide students with midwifery skills. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Episiotomy Wound
- What is being tested?
- Video assisted episiotomy repair training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2024to 15 May 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Midwifery students who are studying in the 3rd year, have taken the normal birth and postpartum period course and are registered for the risky birth and postpartum period course
- Those who volunteer to participate in the study
Who cannot join
- Those who did not agree to participate in the research
- Those who have an active working life as midwives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Video-assisted Episiotomy Repair Training on Anxiety and Self-efficacy Levels in Midwifery Students: a Randomized Controlled Study
The goal of midwifery undergraduate education is; To provide students with basic professional knowledge, skills and attitudes in cognitive, affective and psychomotor dimensions. Various practices are used to provide students with midwifery skills. Case studies, maintenance processes, laboratory applications, field studies, simulation application and video monitoring are some of these applications. Each of these approaches, which are especially preferred in applied courses, has an important place in increasing students' self-efficacy and reducing their anxiety. Episiotomy is one of the obstetric interventions that negatively affects the self-efficacy of midwifery students and causes anxiety. Midwives are responsible for performing and caring for episiotomy. In many countries, episiotomy repair training is given to midwifery students using sponges or models. However, today the use of calf tongue, which is very similar to perineal tissue, has become widespread. There are a limited number of studies in the literature using calf tongue simulation. These studies suggested that the practice improved the skills of midwifery students. No study has been found in the literature using video-assisted episiotomy repair training.
Read the detailed description
Episiotomy is one of the most commonly performed surgical interventions in normal vaginal birth. Episiotomy, also known as perineotomy, can be defined as an incision made in the perineum to ensure easy delivery of the fetus, shorten the active phase of labor, prevent lacerations, and protect the perineal tissue and anal sphincter. This procedure is a surgical intervention applied to the bulbo-cavernos muscle located in the perineum in the second phase of labor. It can be said that episiotomy has become widespread as a result of medicalization in birth, as in all areas of health. In particular, moving births from homes to hospital environments can be cited as one of the leading reasons for the increase in episiotomy rates. Routine episiotomy may cause pelvic organ prolapse and damage the muscles in the anal sphincters and perineal structure. In addition, studies on the subject have shown that episiotomy may be associated with problems such as postpartum pain, dyspareunia and incontinence. It is also known that the rate of perineal trauma is high in countries where episiotomy is frequently performed. For this reason, episiotomy, which is basically done to prevent uncontrolled damage that may occur in the perineal area, is not routinely preferred today. The recommendation of the American College of Obstetricians and Gynecologists (ACOG) regarding episiotomy is as follows: Episiotomy may be preferred in cases of risk arising from the mother or the baby, such as protecting against perineal tears that may occur in the mother during vaginal birth, facilitating or accelerating birth, but its use should be limited in cases where it is not necessary.
Self-efficacy is defined as the individual's beliefs about his ability to perform significantly in events that will affect his life. Self-efficacy perception determines how individuals feel, think, motivate themselves and behave. It is known that motivation increases as the level of self-efficacy increases). It has also been reported that individuals with high self-efficacy have a higher potential to cope with problems, experience less stress and anxiety, and make more effort to achieve their desired results. It is estimated that people with low self-efficacy often experience stress, anxiety and depression, and their academic and social success decreases. As a matter of fact, some studies have found that the academic performance of university students increases in parallel with their self-efficacy score averages.
The goal of midwifery undergraduate education is; To provide students with basic professional knowledge, skills and attitudes in cognitive, affective and psychomotor dimensions. Various practices are used to provide students with midwifery skills. Case studies, maintenance processes, laboratory applications, field studies, simulation application and video monitoring are some of these applications. Each of these approaches, which are especially preferred in applied courses, has an important place in increasing students' self-efficacy and reducing their anxiety. Episiotomy is one of the obstetric interventions that negatively affects the self-efficacy of midwifery students and causes anxiety. Midwives are responsible for performing and caring for episiotomy. In many countries, episiotomy repair training is given to midwifery students using sponges or models. However, today the use of calf tongue, which is very similar to perineal tissue, has become widespread. There are a limited number of studies in the literature using calf tongue simulation. These studies suggested that the practice improved the skills of midwifery students. No study has been found in the literature using video-assisted episiotomy repair training.
- Conditions
- Episiotomy Wound
- Being tested
- Video assisted episiotomy repair training
- Keywords
- Episiotomy, Self-efficacy, Midwifery Students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video assisted episiotomy repair trainingOther
Midwifery Intervention The 'video recording' prepared by researchers specialized in the field of midwifery to increase the episiotomy repair skills of midwifery students will be used as training material. The content of the video recording is as follows: control before episiotomy repair, episiotomy repair, subcutaneous suturing, skin suturing, suturing techniques (Continuous, Simple Intermittent, Mattress). After the video recording is completed, it will be restarted and shown to the students in the experimental group continuously throughout the application period. At the end of the application period, students will be re-evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Standard episiotomy repair training will be given to the students in the experimental group using the calf tongue simulator. After the theoretical phase is completed, the implementation phase will begin. During the application period (practical phase), students in this group will be shown a 'video recording' of episiotomy repair prepared by the researchers as educational material. Thus, students in the experimental group will be able to watch episiotomy repairs whenever and however many times they want, in addition to researcher support throughout the application, and improve their application skills. Receives: Other: Video assisted episiotomy repair training |
| Control group | No intervention | Students in the control group will be given standard episiotomy repair training using the calf tongue simulator. After the theoretical phase is completed, the implementation phase will begin. Researcher support will be provided throughout the implementation period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Scale
Scoring is as follows: "1=Not at all, 2=Somewhat, 3=A lot and 4=Completely." There are two types of expressions in the scale: direct and reverse. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 are scored in reverse. Direct expressions express negative emotions; Inverted expressions contain positive emotions. The scores obtained from the scale theoretically range between 20 and 80. High scores from the scale indicate high anxiety level, low scores indicate low anxiety level.
Measured: through study completion, an average of 1 year
Episiotomy Skills Self-Efficacy Scale
The scale consists of 19 items and two subscales: 'episiotomy preparation and application' and 'episiotomy control'. For each item on the Likert-type scale, "1" is given for the "strongly disagree" response, "2" is given for the "disagree" response, "3" is given for the "agree" response, and "4" is given for the "strongly agree" response. There are no reverse coded items in the scale. The total score varies between 19 and 76. High scores from the scale indicate a high level of self-efficacy for episiotomy skills.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start25 Mar 2024
- Primary completion5 Apr 2024
- Study completion15 May 2024
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348680
- Sponsor's protocol ID
- AmasyaU-betuluzun-004
- Status last verified
- Feb 2025
- First submitted
- 25 Mar 2024
- Last updated
- 25 Feb 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video-assisted Episiotomy Repair Training on Anxiety and Self-efficacy Levels in Midwifery Students: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06348680
- Acronym / sponsor ID
- AmasyaU-betuluzun-004
- Conditions
- Episiotomy Wound
- Keywords
- Episiotomy, Self-efficacy, Midwifery Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 5 Apr 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.
The goal of midwifery undergraduate education is; To provide students with basic professional knowledge, skills and attitudes in cognitive, affective and psychomotor dimensions. Various practices are used to provide students with midwifery skills. Case studies, maintenance processes, laboratory applications, field studies, simulation application and video monitoring are some of these applications. Each of these approaches, which are especially preferred in applied courses, has an important place in increasing students' self-efficacy and reducing their anxiety. Episiotomy is one of the obstetric interventions that negatively affects the self-efficacy of midwifery students and causes anxiety. Midwives are responsible for performing and caring for episiotomy. In many countries, episiotomy repair training is given to midwifery students using sponges or models. However, today the use of calf tongue, which is very similar to perineal tissue, has become widespread. There are a limited number of studies in the literature using calf tongue simulation. These studies suggested that the practice improved the skills of midwifery students. No study has been found in the literature using video-assisted episiotomy repair training.
Detailed description
Episiotomy is one of the most commonly performed surgical interventions in normal vaginal birth. Episiotomy, also known as perineotomy, can be defined as an incision made in the perineum to ensure easy delivery of the fetus, shorten the active phase of labor, prevent lacerations, and protect the perineal tissue and anal sphincter. This procedure is a surgical intervention applied to the bulbo-cavernos muscle located in the perineum in the second phase of labor. It can be said that episiotomy has become widespread as a result of medicalization in birth, as in all areas of health. In particular, moving births from homes to hospital environments can be cited as one of the leading reasons for the increase in episiotomy rates. Routine episiotomy may cause pelvic organ prolapse and damage the muscles in the anal sphincters and perineal structure. In addition, studies on the subject have shown that episiotomy may be associated with problems such as postpartum pain, dyspareunia and incontinence. It is also known that the rate of perineal trauma is high in countries where episiotomy is frequently performed. For this reason, episiotomy, which is basically done to prevent uncontrolled damage that may occur in the perineal area, is not routinely preferred today. The recommendation of the American College of Obstetricians and Gynecologists (ACOG) regarding episiotomy is as follows: Episiotomy may be preferred in cases of risk arising from the mother or the baby, such as protecting against perineal tears that may occur in the mother during vaginal birth, facilitating or accelerating birth, but its use should be limited in cases where it is not necessary.
Self-efficacy is defined as the individual's beliefs about his ability to perform significantly in events that will affect his life. Self-efficacy perception determines how individuals feel, think, motivate themselves and behave. It is known that motivation increases as the level of self-efficacy increases). It has also been reported that individuals with high self-efficacy have a higher potential to cope with problems, experience less stress and anxiety, and make more effort to achieve their desired results. It is estimated that people with low self-efficacy often experience stress, anxiety and depression, and their academic and social success decreases. As a matter of fact, some studies have found that the academic performance of university students increases in parallel with their self-efficacy score averages.
The goal of midwifery undergraduate education is; To provide students with basic professional knowledge, skills and attitudes in cognitive, affective and psychomotor dimensions. Various practices are used to provide students with midwifery skills. Case studies, maintenance processes, laboratory applications, field studies, simulation application and video monitoring are some of these applications. Each of these approaches, which are especially preferred in applied courses, has an important place in increasing students' self-efficacy and reducing their anxiety. Episiotomy is one of the obstetric interventions that negatively affects the self-efficacy of midwifery students and causes anxiety. Midwives are responsible for performing and caring for episiotomy. In many countries, episiotomy repair training is given to midwifery students using sponges or models. However, today the use of calf tongue, which is very similar to perineal tissue, has become widespread. There are a limited number of studies in the literature using calf tongue simulation. These studies suggested that the practice improved the skills of midwifery students. No study has been found in the literature using video-assisted episiotomy repair training.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Video assisted episiotomy repair trainingStandard episiotomy repair training will be given to the students in the experimental group using the calf tongue simulator. After the theoretical phase is completed, the implementation phase will begin. During the application period (practical phase), students in this group will be shown a 'video recording' of episiotomy repair prepared by the researchers as educational material. Thus, students in the experimental group will be able to watch episiotomy repairs whenever and however many times they want, in addition to researcher support throughout the application, and improve their application skills. |
| Control group | No intervention | –Students in the control group will be given standard episiotomy repair training using the calf tongue simulator. After the theoretical phase is completed, the implementation phase will begin. Researcher support will be provided throughout the implementation period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Midwifery students who are studying in the 3rd year, have taken the normal birth and postpartum period course and are registered for the risky birth and postpartum period course
- Those who volunteer to participate in the study
Key exclusion criteria (2 listed)
- Those who did not agree to participate in the research
- Those who have an active working life as midwives
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 |
|---|---|---|
| Video assisted episiotomy repair trainingMidwifery Intervention The 'video recording' prepared by researchers specialized in the field of midwifery to increase the episiotomy repair skills of midwifery students will be used as training material. The content of the video recording is as follows: control before episiotomy repair, episiotomy repair, subcutaneous suturing, skin suturing, suturing techniques (Continuous, Simple Intermittent, Mattress). After the video recording is completed, it will be restarted and shown to the students in the experimental group continuously throughout the application period. At the end of the application period, students will be re-evaluated. | Other | Experimental group |
Primary outcome
State Anxiety Scale
Time frame: through study completion, an average of 1 year
Scoring is as follows: "1=Not at all, 2=Somewhat, 3=A lot and 4=Completely." There are two types of expressions in the scale: direct and reverse. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 are scored in reverse. Direct expressions express negative emotions; Inverted expressions contain positive emotions. The scores obtained from the scale theoretically range between 20 and 80. High scores from the scale indicate high anxiety level, low scores indicate low anxiety level.
Episiotomy Skills Self-Efficacy Scale
Time frame: through study completion, an average of 1 year
The scale consists of 19 items and two subscales: 'episiotomy preparation and application' and 'episiotomy control'. For each item on the Likert-type scale, "1" is given for the "strongly disagree" response, "2" is given for the "disagree" response, "3" is given for the "agree" response, and "4" is given for the "strongly agree" response. There are no reverse coded items in the scale. The total score varies between 19 and 76. High scores from the scale indicate a high level of self-efficacy for episiotomy skills.
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 25 Feb 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 Video assisted episiotomy repair training in people with Episiotomy Wound, run by Amasya 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 25 Feb 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?
State Anxiety Scale (time frame: through study completion, an average of 1 year). The study lists 2 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 25 Feb 2025.