NCT05502640

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

April 25, 2022

Last Update Submit

May 18, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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).

    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.

    immediately after training

Study Arms (2)

sponge group

OTHER

Control group

Other: Routine Education model

Chicken group

EXPERIMENTAL
Other: Education model

Interventions

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.

Chicken 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.

Also known as: Sponge Group
sponge group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Nursing

Ankara, 06230, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr.

Study Record Dates

First Submitted

April 25, 2022

First Posted

August 16, 2022

Study Start

September 15, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations