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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Amasya University

    Amasya, Center, 05000

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06348680
Study groupRoleWhat they receive
Experimental groupExperimentalStandard 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 groupNo interventionStudents 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.

  1. 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

  2. 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.

  1. First posted5 Apr 2024
  2. Study start25 Mar 2024
  3. Primary completion5 Apr 2024
  4. Study completion15 May 2024

Resources

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)
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

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.

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