Self ConfidenceNCT05143749
Pandemic and Gynecological Surgery Education
A study testing video tutorial in people with Self Confidence, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
SarsCov2/COVID19 virus emerged in Wuhan, China in December 2019, and cases were seen in our country about 3 months later, causing a worldwide pandemic. In this process, both the stress caused by the risk of contracting the disease and the social restrictions affected life deeply. Read more about this study
- Who is it for?
- Ages 24 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Self Confidence
- What is being tested?
- video tutorial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Nov 2021to 31 Mar 2025
- 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 24 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Exclusion Criteria:not yet receive gynecological assistant training
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Video Use and Self-evaluation on Gynecological Surgery Education in the Light of Current Technological Developments in the Pandemic
SarsCov2/COVID19 virus emerged in Wuhan, China in December 2019, and cases were seen in our country about 3 months later, causing a worldwide pandemic. In this process, both the stress caused by the risk of contracting the disease and the social restrictions affected life deeply.
578 / 5000 Çeviri sonuçları This study will be beneficial for the assistant doctors in recognizing technical errors in gynecological operations, reducing the risks and improving the results.
Surgical operation trainings such as hysterectomy and oophorectomy fistula surgery can be given with laparotomy-guided simulators, which can offer interactive training for gynecological operations in adult female sizes and show high adaptability. However, it is not possible to train major vaginal surgical operations with this method today. At this point, video tutorials can be used. This study was planned with the aim of increasing the level of anxiety about the training of the residents during the pandemic period, with the aim of making positive changes in order to increase the assistant's own skills, realize his mistakes and reduce the level of anxiety with video training.
Read the detailed description
Our study is a Prospective Cross-sectional Case Control study. Our study is a training study and our assistants included in the study will consist of two groups. Group 1: A total of 10 assistants who have just completed the gynecological surgery training, which is in the last 4 months of a total of 8 months of training during the pandemic process, and Group 2 is 4 . It will consist of 10 assistants who have just started their surgical training after the first month. The assistants in Group 2 will videotape their first, fifth, tenth, fifteenth and twentieth gynecological operations, then watch their own operations to test their skills. Written consent will be obtained from the patients for the video recording of the operations, stating that the operations will be used for educational purposes only before the operation.
Operations are planned as abdominal hysterectomy, vaginal hysterectomy and myomectomy, which are the most performed gynecological operations.
Video applied to the residents in Group 1, who completed their training in the last 4 months of the pandemic process, and to the residents in Group 2, who completed their training by watching the video footage of their own operations, by applying the Self-Confidence Scale, General Self-Efficacy Scale, State Anxiety Inventory (DCI) and Trait Anxiety Inventory (SCI) scales. The effect of education on residents' anxiety, competence and self-confidence will be investigated.
After the training, the operations performed by the residents will be analyzed and the average operation time, intraoperative and postoperative major and minor complication rates, bleeding amounts in the operations, preoperative and postoperative hemogram amounts, postoperative hospital stay of the patients, postoperative analgesia need parameters will be evaluated and a comparison will be made between the two groups. In this way, the effect of video training on the lurning curve will be investigated.
- Conditions
- Self Confidence
- Being tested
- video tutorial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video tutorialOther
get video tutorial
| Study group | Role | What they receive |
|---|---|---|
| 10 assistant doctors who received video training | Experimental | 10 assistant doctors who receive video training will be the intervention arm Receives: Other: video tutorial |
| 10 assistant doctors who did not receive video training | No intervention | 10 assistant doctors who did not receive video training will be the control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
self confidence
Self-confidence level will be tested in the group receiving video training.
Measured: minimum 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start22 Nov 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Why it stopped: technical support not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self ConfidenceStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahime Bedir Fındık, Ankara City Hospital Bilkent
- Investigators
- Rahime Bedir Findik, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143749
- Sponsor's protocol ID
- AnkaraCHBilkent-MH-RBF-03
- Status last verified
- Jul 2023
- First submitted
- 22 Nov 2021
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Video Use and Self-evaluation on Gynecological Surgery Education in the Light of Current Technological Developments in the Pandemic
- ClinicalTrials.gov ID
- NCT05143749
- Acronym / sponsor ID
- AnkaraCHBilkent-MH-RBF-03
- Conditions
- Self Confidence
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: technical support not available
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 3 Dec 2021 (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.
SarsCov2/COVID19 virus emerged in Wuhan, China in December 2019, and cases were seen in our country about 3 months later, causing a worldwide pandemic. In this process, both the stress caused by the risk of contracting the disease and the social restrictions affected life deeply.
578 / 5000 Çeviri sonuçları This study will be beneficial for the assistant doctors in recognizing technical errors in gynecological operations, reducing the risks and improving the results.
Surgical operation trainings such as hysterectomy and oophorectomy fistula surgery can be given with laparotomy-guided simulators, which can offer interactive training for gynecological operations in adult female sizes and show high adaptability. However, it is not possible to train major vaginal surgical operations with this method today. At this point, video tutorials can be used. This study was planned with the aim of increasing the level of anxiety about the training of the residents during the pandemic period, with the aim of making positive changes in order to increase the assistant's own skills, realize his mistakes and reduce the level of anxiety with video training.
Detailed description
Our study is a Prospective Cross-sectional Case Control study. Our study is a training study and our assistants included in the study will consist of two groups. Group 1: A total of 10 assistants who have just completed the gynecological surgery training, which is in the last 4 months of a total of 8 months of training during the pandemic process, and Group 2 is 4 . It will consist of 10 assistants who have just started their surgical training after the first month. The assistants in Group 2 will videotape their first, fifth, tenth, fifteenth and twentieth gynecological operations, then watch their own operations to test their skills. Written consent will be obtained from the patients for the video recording of the operations, stating that the operations will be used for educational purposes only before the operation.
Operations are planned as abdominal hysterectomy, vaginal hysterectomy and myomectomy, which are the most performed gynecological operations.
Video applied to the residents in Group 1, who completed their training in the last 4 months of the pandemic process, and to the residents in Group 2, who completed their training by watching the video footage of their own operations, by applying the Self-Confidence Scale, General Self-Efficacy Scale, State Anxiety Inventory (DCI) and Trait Anxiety Inventory (SCI) scales. The effect of education on residents' anxiety, competence and self-confidence will be investigated.
After the training, the operations performed by the residents will be analyzed and the average operation time, intraoperative and postoperative major and minor complication rates, bleeding amounts in the operations, preoperative and postoperative hemogram amounts, postoperative hospital stay of the patients, postoperative analgesia need parameters will be evaluated and a comparison will be made between the two groups. In this way, the effect of video training on the lurning curve will be investigated.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 assistant doctors who received video training | Experimental | Other: video tutorial10 assistant doctors who receive video training will be the intervention arm |
| 10 assistant doctors who did not receive video training | No intervention | –10 assistant doctors who did not receive video training will be the control arm |
Who may qualify
- Ages
- 24 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Exclusion Criteria:not yet receive gynecological assistant training
- -
Key exclusion criteria (0 listed)
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 tutorialget video tutorial | Other | 10 assistant doctors who received video training |
Primary outcome
self confidence
Time frame: minimum 3 months
Self-confidence level will be tested in the group receiving video training.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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.
Rahime Bedir Findik principal investigator
Ankara City Hospital Bilkent
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 tutorial in people with Self Confidence, run by Ankara City Hospital Bilkent 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 0 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: paused, as of the sponsor's last update on 27 Jul 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?
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 confidence (time frame: minimum 3 months). 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 27 Jul 2023.