Effects of laparoscopic sleeve gastrectomy on level of depression and dignity in adults who attended to Shiraz Ghadir Mother and ChildSubspecialized Hospital
Investigate the effects of laparoscopic sleeve gastrectomy on level of depression and dignity in adults who attended to Shiraz Ghadir Mother and Child Sub specialized Hospital
Design
The design of this research is a follow-up pre-test post-test with control group
Settings and conduct
The statistical population of this study is all obese patients who underwent laparoscopic surgery from November 2012 to September 2012 in Mother and Child Hospital in Ghadir, Shiraz.
Using 60 available sampling methods, 60 of them will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 21 to 55 years, BMI
Top 35 Having at least education in reading and writing, patient consent with written consent for participation in research
Exclusion criteria: Severe psychiatric disorders and their related problems
Intervention groups
The experimental group will undergo surgery and the control group will not intervene
After the end of the research, the control group will also undergo surgery
Main outcome variables
Self-esteem, Depression, energy loss, disturbance of concentration, sleep disturbances and appetite, physical pains, headaches and problems Gastrointestinal tract.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180523039802N1
Registration date:2018-08-12, 1397/05/21
Registration timing:registered_while_recruiting
Last update:2018-08-12, 1397/05/21
Update count:0
Registration date
2018-08-12, 1397/05/21
Registrant information
Name
Zahra Sobhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3227 9711
Email address
zahrasobhani120@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-21, 1396/08/30
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of laparoscopic sleeve gastrectomy on level of depression and dignity in adults who attended to Shiraz Ghadir Mother and ChildSubspecialized Hospital
Public title
Effects of laparoscopic sleeve gastrectomy on level of depression and dignity in adults who attended to Shiraz Ghadir Mother and ChildSubspecialized Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 21-55 years,
BMI greater than 35,
ability to read and write and patient
agreement by submitting a written consent for participation in the research
Exclusion criteria:
Diabetes mellitus, Hypertension, Thyroid disorders
Psychosis, Mania, schizophrenia
Inability to read and write
Disagreement with the patient to participate in the research
Age
From 21 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
With power analysis, sixty of statistical population will be selected by using available sampling method and randomly simply with registration software in the hospital with matching divide into two groups (experimental and control).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The statistical population will include all obese patients (BMI ≥ 35) who are literate (at least reading and writing) and are aged 21 to 55 years (mean 28.23 and standard deviation 87.9); also, they are applicants for laparoscopic sleeve gastrectomy in Shiraz Ghadir Mother and Child Hospital during spring and summer of 2017. Sixty of them will be selected by using available sampling method and randomly with matching divide into two groups (experimental and control).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Street, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2017-08-05, 1396/05/14
Ethics committee reference number
IR.SUMS.REC.1396.S391
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Depression
Timepoint
Before bariatric surgery and 3 to 6 months after bariatric surgery
Method of measurement
Beck Depression Inventory
2
Description
Self-esteem
Timepoint
Before bariatric surgery and 3 to 6 months after bariatric surgery
Method of measurement
3- Rosenberg Self-Esteem Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group will undergo for bariatric surgery .
Category
Treatment - Surgery
2
Description
Control group: This group will not receive any intervention.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Obesity Clinic of Shiraz University Of Medical Sciences
Full name of responsible person
Zahra Sobhani
Street address
laparascopy Research Center, Mother and Child Hospital Ghadir, above gate Quran, First Town Gulshan, Shiraz, iran.
City
Shiraz
Province
Fars
Postal code
71449-9537
Phone
+98 71 3227 9711
Fax
+98 71 3227 9711
Email
zahrasobhani120@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi, MD
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Sobhani
Position
Ph.D non-faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
laparascopy Research Center, Mother and Child Hospital Ghadir, above gate Quran, First Town Gulshan, Shiraz, iran.
City
Shiraz
Province
Fars
Postal code
71449-9537
Phone
+98 71 3227 9711
Fax
+98 71 3227 9711
Email
zahrasobhani120@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Vahid hosseini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Colorectal Research Center, Mohammad Rasolalah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3628 1453
Email
hoseiniv@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Sobhani
Position
Ph.D non-faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
laparascopy Research Center, Mother and Child Hospital Ghadir, above gate Quran, First Town Gulshan, Shiraz, iran.
City
Shiraz
Province
Fars
Postal code
71449-9537
Phone
+98 71 3227 9711
Fax
+98 71 3227 9711
Email
zahrasobhani120@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the fact that the study is not yet done, so there is no data file for publication