Protocol summary
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Study aim
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Improvement of the skill indicators of second and third year residences of the department of obstetrics and gynecology in the uterine and ovarian arteries ligation
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Design
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Sample size: 46 (Mashhad: 30 [third year residents:15, second year residents:15] , Zahedan: 30 [third year residents:8, second year residents:8])
Randomization: Simple via www.randomization.com website
Study design: Randomized control trial, two arm, concurrent parallel
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Settings and conduct
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Setting: OmolBanin hospital in Mashhad medical university and ImamAli hospital in Zahedan medical university.
Blinded peoples: 1-Assessors in pre and post test, 2-Statistical analyzer.
The second and third year obstetrics and gynecology residents who are studying in the current academic year are subjected to a pre-test by a questionnaire that will be finally validated and verified. Then an educational serious game will be designed to train the skill indicators of the second and third year residents in the uterine and ovarian arteries ligation. Residents in the intervention group will interact with the educational serious game, and will meet gradual and academic training during the engagement with this game. Then they will be asked for the post-test. This intervention is expected to be effective, and the score of the intervention group is significantly higher than that of the control group in the post-test, which is indicative of improving their skill indicators in closure of the uterine and ovarian arteries ligation.
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Participants/Inclusion and exclusion criteria
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The second and third year obstetrics and gynecology residents
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Intervention groups
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The second and third year obstetrics and gynecology residents
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Main outcome variables
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Skill indicators difference between intervention and control groups in uterine and ovarian arteries ligation
General information
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Reason for update
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We received confirmation code in pervious format from irct.ir; it was in short site. In the new format, we intend to give the public our project data completely and clearly. We therefore updated site.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017092436366N1
Registration date:
2017-10-23, 1396/08/01
Registration timing:
prospective
Last update:
2020-11-23, 1399/09/03
Update count:
1
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Registration date
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2017-10-23, 1396/08/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Deputy of Research, Mashhad University of Medical Sciences
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Expected recruitment start date
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2017-11-22, 1396/09/01
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Expected recruitment end date
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2018-11-22, 1397/09/01
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Actual recruitment start date
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2017-11-22, 1396/09/01
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Actual recruitment end date
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2018-11-22, 1397/09/01
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Trial completion date
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2018-11-22, 1397/09/01
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Scientific title
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Designing and evaluating an educational serious game to improve the Skill Indicators of obstetrics and gynecology residents
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Public title
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Design and evaluation of an educational Serious Game to uterine artery ligation
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
resident of the second and third year of obstetrics and gynecology
Exclusion criteria:
no participation of resident in the pre-test
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Age
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From 20 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
47
Actual sample size reached:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Method of randomization: simple
tools used in randomization: randomization.com website
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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healthcare providers (OSATs assessor) and outcome assessors were blinded.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-09-06, 1396/06/15
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Ethics committee reference number
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IR.MUMS.fm.REC.1396.345
Health conditions studied
1
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Description of health condition studied
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Uterine Artery Ligation
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Indicators of operative skills
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Timepoint
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Two months after the end of the intervention
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Method of measurement
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OSATS Checklist
Intervention groups
1
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Description
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Educational Serious Game in Intervention Group
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Deputy of Research of Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The data will all be anonymous and encrypted. So, all the data will be shared.
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When the data will become available and for how long
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Once the results are published indefinitely, unlimited access will be possible.
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To whom data/document is available
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There is no limitation.
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Under which criteria data/document could be used
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There is no limitation.
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From where data/document is obtainable
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We pledge to respond by taram@mums.ac.ir
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What processes are involved for a request to access data/document
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We pledge to respond within one business day by taram@mums.ac.ir
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Comments
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