This is part of a multicenter study. Colleagues from George Washington University will provide the simulators. This study has 4 phases. First, anatomic structure of the simulator will be investigated by professional otologists. Participants will get familiar with device and an educational video will be played for them; then residents will be divided to 3 groups: 1) doing surgery on simulator, 2) removing a holed ball from the simulator, 3) not using simulator. After this phase all of the participants will perform surgery on simulator. All of the surgeries will be recorded and scored by 3 experts. After this phase all of the participants will perform surgery in the operating room and will be evaluated. Evaluation will be repeated after 3, 6, and 12 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013050110041N2
Registration date:2013-06-12, 1392/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-12, 1392/03/22
Registrant information
Name
Ali Kouhi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 3037
Email address
a-kouhi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences & George Washington University
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of a middle ear surgical simulator as an educational tool for ENT residents in stapes surgery
Public title
Evaluation of a middle ear surgical simulator as an educational tool for ENT residents in stapes surgery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion crtiterion: residents of otolarynglogy in Tehran University of Medical Sciences.
Exclusion: refusal to attend the project; previous experience with simulator.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Ghods st.
City
Tehran
Postal code
Approval date
2013-02-25, 1391/12/07
Ethics committee reference number
91-04-48-20441-79592
Health conditions studied
1
Description of health condition studied
otosclerosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Performance in stapedectomy
Timepoint
1, 3, 6 and 12 months
Method of measurement
Observation
Secondary outcomes
1
Description
Performance on simulator
Timepoint
12th month
Method of measurement
Observation
Intervention groups
1
Description
practice on removing ball from a hole.
This group is designed to study if practicing on simulator is a confounding factor and whether it only improves psychomotor or improves stapedectomy surgical skill.
Category
Treatment - Surgery
2
Description
practice on simulator
Category
Treatment - Surgery
3
Description
no simulator.
this is a control group and is used to compare results with other groups.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-Alam hospital
Full name of responsible person
Ali Kouhi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Miss. Nouruz zadeh
Street address
Ghods, st. research office
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Kouhi
Position
Assistant professor
Other areas of specialty/work
Street address
Amir-Alam Hospital
City
Tehran
Postal code
Phone
+98 21 6670 3037
Fax
Email
a-kouhi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Kouhi
Position
Assistant professor
Other areas of specialty/work
Street address
Amir- Alam Hospital
City
Tehran
Postal code
Phone
+98 21 6670 3037
Fax
Email
a-kouhi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Kouhi
Position
Assistant professor
Other areas of specialty/work
Street address
Amir-Alam Hospital
City
Tehran
Postal code
Phone
+98 21 6670 3037
Fax
Email
a-kouhi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)