Shoulder DystociaNCT05660551
Investigation of the Effect of Different Training Techniques in Teaching the Management of Shoulder Dystocia
A study testing Demostration, Telesimulation and Kahoot Game in people with Shoulder Dystocia, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to determine the effect of demonstration, telesimulation and game-based teaching on teaching shoulder dystocia management in midwifery students. H01: There is no difference between the four groups in terms of satisfaction with learning. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Dystocia
- What is being tested?
- Demostration, Telesimulation and Kahoot Game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Dec 2022to 30 Jan 2023
- 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
- Being a registered student in the midwifery department,
- Having the ability to manage normal birth,
- Having a smart phone, tablet or computer with internet connection,
- Agreeing to participate in the research
Who cannot join
- to suspend education.
- Having received formal training on shoulder dystocia management.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Nursing
Ankara, 06620
About this study
Official title: Effect of Different Training Techniques in Teaching the Management of Shoulder Dystocia
In this study, it was aimed to determine the effect of demonstration, telesimulation and game-based teaching on teaching shoulder dystocia management in midwifery students.
H01: There is no difference between the four groups in terms of satisfaction with learning.
H02: There is no difference between the four groups in terms of Self-Confidence in Learning.
H03: There is no difference between the four groups in terms of Motivation scores in Teaching Materials.
- Conditions
- Shoulder Dystocia
- Being tested
- Demostration, Telesimulation, Kahoot Game
- Medical subject headings
- Shoulder Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DemostrationOther
This group will be demonstrated on a model after the theoretical training. The maneuvers used in the management of shoulder dystocia will be shown to the students on the model, respectively.
TelesimulationOther
After the theoretical training for this group, telesimulation will be applied. A scenario will be created for the telesimulation experience and a video will be shot with this scenario. These videos will be watched by the students in groups of 4 on Microsoft Teams and a case discussion will be made through this scenario.
Kahoot GameOther
Kahoot, a game-based program, will be applied to this group one week after the theoretical training. The game will be organized according to the learning objectives and achievements related to shoulder dystocia.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Demonstration group | Experimental | Not described Receives: Other: Demostration |
| Telesimulation Group | Experimental | Not described Receives: Other: Telesimulation |
| Kahoot Game Group | Experimental | Not described Receives: Other: Kahoot Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Dystocia Skill Checklist
The skill checklist prepared by the researcher by scanning the literature consists of three parts (Taşkın, 2016; Sayıner \& Başkaya, 2020); diagnosing shoulder dystocia, making the necessary interventions for shoulder dystocia at birth, and intervention after birth.In the skill list, the student will receive 1 point for each correct application, and 0 points for each incorrect or skipped application.Higher scores indicate higher skill levels.
Measured: 15 days after the training
Instructional Materials Motivation Survey
The Instructional Materials Motivation Survey (IMMS) aims to assess the motivational characteristics of instructional materials or courses using the Attention, Relevance, Confidence, and Satisfaction (ARCS) model of motivation. The five-point Likert type scale consists of 36 items in the original scale.
In the last Turkish adaptation study, 3 of the items were excluded from the original scale and a total of 33 items were included in the Turkish version of the scale.
Measured: 15 days after the training
Change in 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start23 Dec 2022
- Primary completion23 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DystociaStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 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
- NCT05660551
- Sponsor's protocol ID
- 737219
- Status last verified
- Jun 2023
- First submitted
- 13 Dec 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Training Techniques in Teaching the Management of Shoulder Dystocia
- ClinicalTrials.gov ID
- NCT05660551
- Acronym / sponsor ID
- 737219
- Conditions
- Shoulder Dystocia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 21 Dec 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.
In this study, it was aimed to determine the effect of demonstration, telesimulation and game-based teaching on teaching shoulder dystocia management in midwifery students.
H01: There is no difference between the four groups in terms of satisfaction with learning.
H02: There is no difference between the four groups in terms of Self-Confidence in Learning.
H03: There is no difference between the four groups in terms of Motivation scores in Teaching Materials.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Demonstration group | Experimental | Other: Demostration |
| Telesimulation Group | Experimental | Other: Telesimulation |
| Kahoot Game Group | Experimental | Other: Kahoot Game |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being a registered student in the midwifery department,
- Having the ability to manage normal birth,
- Having a smart phone, tablet or computer with internet connection,
- Agreeing to participate in the research
Key exclusion criteria (2 listed)
- to suspend education.
- Having received formal training on shoulder dystocia management.
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 |
|---|---|---|
| DemostrationThis group will be demonstrated on a model after the theoretical training. The maneuvers used in the management of shoulder dystocia will be shown to the students on the model, respectively. | Other | Demonstration group |
| TelesimulationAfter the theoretical training for this group, telesimulation will be applied. A scenario will be created for the telesimulation experience and a video will be shot with this scenario. These videos will be watched by the students in groups of 4 on Microsoft Teams and a case discussion will be made through this scenario. | Other | Telesimulation Group |
| Kahoot GameKahoot, a game-based program, will be applied to this group one week after the theoretical training. The game will be organized according to the learning objectives and achievements related to shoulder dystocia. | Other | Kahoot Game Group |
Primary outcome
Shoulder Dystocia Skill Checklist
Time frame: 15 days after the training
The skill checklist prepared by the researcher by scanning the literature consists of three parts (Taşkın, 2016; Sayıner \& Başkaya, 2020); diagnosing shoulder dystocia, making the necessary interventions for shoulder dystocia at birth, and intervention after birth.In the skill list, the student will receive 1 point for each correct application, and 0 points for each incorrect or skipped application.Higher scores indicate higher skill levels.
Instructional Materials Motivation Survey
Time frame: 15 days after the training
The Instructional Materials Motivation Survey (IMMS) aims to assess the motivational characteristics of instructional materials or courses using the Attention, Relevance, Confidence, and Satisfaction (ARCS) model of motivation. The five-point Likert type scale consists of 36 items in the original scale. In the last Turkish adaptation study, 3 of the items were excluded from the original scale and a total of 33 items were included in the Turkish version of the scale.
Change in Self-Sufficiency
Time frame: immediately before the training, immediately after the training
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).
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 18 Jun 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 Demostration, Telesimulation and Kahoot Game in people with Shoulder Dystocia, 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 4 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 18 Jun 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?
Shoulder Dystocia Skill Checklist (time frame: 15 days after the training). The study lists 3 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 18 Jun 2023.