Protocol summary

Summary
The purpose of this study is to compare Personality trait, marital satisfaction and self confidence before and after bariatric surgery in morbid obese patients in Rasool-e-Akram hospital in1391. This Study is performed on morbid obese patients with BMI over 40 or BMI over 35 with one obese comorbidity, who will undergo bariatric surgery and the patients with inability to complete the questionnaire for any reasons are excluded. The morbid obese patients who are candidates for bariatric surgery in obesity clinic of Rasool-e-Akram hospital in 1391 are studied and the sample size is 68. In cases by using the Neo test assays Personality trait, with Cooper Smith test assays Self confidence, Mariatal satisfaction is checked by using the Enrich test. The patients will undergo bariatric surgery for a uniform method and after six months these factors will be checked by using above tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201207028588N9
Registration date: 2012-08-20, 1391/05/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-08-20, 1391/05/30
Registrant information
Name
Mohadeseh Pishgahroudsari
Name of organization / entity
Mnimally Invasive Surgery Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 5447
Email address
research@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences.
Expected recruitment start date
2012-06-30, 1391/04/10
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of marital satisfaction, confidence and personality characteristics before and after Bariatric laparoscopic surgery in morbid obese patients in Hazrat-e- Rasool Hospital in 1391
Public title
Effects of obesity surgery on self-esteem, personality characteristics and marital satisfaction
Purpose
Prevention
Inclusion/Exclusion criteria
Including criteria: Obese patients with BMI over 40 or over 35 with one obese comorbidity who are undergoing obesity surgery.Excluding criteria: the patients with inability to complete the questionnaire for any reasons.
Age
From 15 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Postal code
Approval date
2012-06-30, 1391/04/10
Ethics committee reference number
54163

Health conditions studied

1

Description of health condition studied
confidence,marital satisfaction, personality trait
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
self-esteem
Timepoint
Before intervention,6 month after intervention
Method of measurement
Cooper Smith questionnaire

2

Description
marital satisfaction
Timepoint
Before intervention,6 month after intervention
Method of measurement
Enrich questionnaire

3

Description
examining personality disorder and trait
Timepoint
Before intervention,6 month after intervention
Method of measurement
Neo questionnaire

Secondary outcomes

1

Description
Aggression
Timepoint
Befor intervention, 6 month after intervention
Method of measurement
Question

Intervention groups

1

Description
Laparoscopic bariatric surgery
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool-e-Akram Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences.
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
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
Dr.Tahereh Lotfi
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Tehran Psychiatric Institute, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
00
Fax
+98 989181077750
Email
lotfi_z28@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences.
Full name of responsible person
Dr.Atefeh Ghanbari
Position
Psychiatrist
Other areas of specialty/work
Street address
Tehran Psychiatric Institute, Niyayesh Ave, Sattarkhan St.,Mansouri St., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6655 1515
Fax
Email
draghj@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Minimally Invasive Surgery Research Center
Full name of responsible person
Mohadeseh pishgahroudsari
Position
Expert stata
Other areas of specialty/work
Street address
Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
research@lapsurg.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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