Determination And Comparison Of Biochemical And Anthropometric Indices In Patients With Ileostomy In Both Intervention And Control Groups To Investigate The Effect Of Smart Phone-Based Nutrition Education.
Design
This Is A Quasi-Experimental Clinical Trial With A Control Group. 60 Patients With Ileostomy Were Selected According to Inclusion Criteria And Divided Into Two Groups Of Control (30) And Intervention (30).
Settings and conduct
The First Stage Is Performed In Imam Khomeini Hospital And The Second stage Is Three Weeks After Ileostomy Insertion At Surgical Clinic of Imam Khomeini Hospital. Anthropometric Indices By Researcher And Biochemical Parameters Are Measured By Sending Blood Samples To The Central Laboratory Of Imam Khomeini Hospital.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Not Having A Special Diet Related To Underlying Illness;
Having An Android Smartphone; Having At Least Reading And Writing Skills; Ability To Work With Smartphones; Able To Communicate, Initiate Oral Nutrition Before 7 Days After Surgery; Lack Of Known Psychological Illnesses. Exclusion Criteria: Unwilling To Participate In The Study; Lack Of Cooperation In The Study; Not Attending A Training Session; Readmission; Longer Hospitalization Time Due to Problems Caused During Surgery; Starting Chemotherapy Before The Third Week After The Implantation of Postoperative Ileostomy In Patients.
Intervention groups
For Both Control And Intervention Groups, The First Step Is To Complete The Demographic Questionnaire And Anthropometric And Biochemical Studies In Two Stages, The Control Group Is Trained By The Staff In Routine And In The Intervention Group, Nutrition Education Is Smartphone-Based.
Main outcome variables
It Is Hoped That Smart Nutrition Education Will Help Reduce The Changes In Biochemical And Anthropometric Indices In These Center, If The Research Results Are Positive.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180615040106N1
Registration date:2018-08-26, 1397/06/04
Registration timing:registered_while_recruiting
Last update:2018-08-26, 1397/06/04
Update count:0
Registration date
2018-08-26, 1397/06/04
Registrant information
Name
Ghazaleh Akhoondian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
akhondian.gh@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-05, 1397/05/14
Expected recruitment end date
2018-09-05, 1397/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study Of The Effect Of Smartphone-based Nutrition Education On Biochemistry And Anthropometric Indices Of Ileostomy Subjects
Public title
"The Effect Of Nutrition Education In Ileostomy Patients With Smartphone"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Not Having A Particular Diet Related To Underlying Disease, Including Diabetics, Low Salt And Low Fat, And ...
Owning A Smartphone With Android OS
Have At Least Reading And Writing Skills.
Ability To Work With Smartphone.
Mighty To Communicate.
Starting Oral Nutrition Before 7 Days After Surgery.
Lack Of Known Psychological Diseases.
Exclusion criteria:
Unwilling To Participate In The Study.
Lack Of Cooperation In The Study.
Not Attending A Training Session.
Readmission (Due to: Non-nutritional Items, Including: Wound Infection, Stomach Hernia, etc.)
Longer Hospitalization Time Due to Problems Caused During Surgery.
Starting Chemotherapy Before The Third Week After The Implantation of Postoperative Ileostomy In Patients.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
60
Randomization (investigator's opinion)
Not 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
Ethics committee of Iran University of Medical Sciences
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Approval date
2017-10-26, 1396/08/04
Ethics committee reference number
IR.IUMS.FMD.REC1396.9413686001
Health conditions studied
1
Description of health condition studied
People With Ileostomy
ICD-10 code
Z43.2
ICD-10 code description
Encounter for attention to ileostomy
Primary outcomes
1
Description
The number Of Lymphocytes
Timepoint
This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy.
Method of measurement
Complete Blood Count Test Kit
2
Description
Hemoglobin Index
Timepoint
This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy.
Method of measurement
Complete Blood Count Test Kit
3
Description
Albumin Index
Timepoint
This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy.
Method of measurement
Albumin Assay Kit
4
Description
Transferring Index
Timepoint
This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy.
Method of measurement
Transferrin Assay Kit
5
Description
C Reactive Protein
Timepoint
This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy.
Method of measurement
C Reactive Protein Elisa Kit
6
Description
Body Mass Index
Timepoint
This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy.
Method of measurement
Calculation Of Height Based On Meter And Weight In Kilograms And Placing In The Formula Of Division Of Weight Into Squared Height
7
Description
Midarm circumference
Timepoint
This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy.
Method of measurement
Measure with Cloth Meter
8
Description
Tricuspid skin fold thickness
Timepoint
This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy.
Method of measurement
Measure With Caliper
9
Description
Waist circumference
Timepoint
This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy.
Method of measurement
Measure With Cloth Meter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Smartphone Training Is Based On Two Sessions Of Instruction For The Installation And Use Of The App, Which Includes Nutrition And Diet, After The Surgery, Before The Patient Is Discharged. The First Session Will Include Introducing The App And Installing A Training Program On The Patient's Or His Family's Smartphone, And In The Second Session You Will Learn How To Use The App And Answer Questions Related To The App. Anthropometric Analyzes (Including Measurements Of Body Mass Index, Median Arm Circumference, Skin Thickness In The Trunk Head And Waist Profile) And Biochemical (Including: Hemoglobin, Albumin, Transferrin, Reactive Protein C, Number Of Lymphocytes) In Order To See The Result Of Training In Nutritional Indices In Patients With Ileostomy, It Is Done In Two Steps. The First Stage, The Day Before The Surgery, Is Considered In The Pre-Intervention Phase, And The Second Stage Is Three Weeks After The Surgery And The Insertion Of The Ileostomy.
Category
Lifestyle
2
Description
Control Group: Applying Appropriate Nutrition and Nutrition Training is Done by The Relevant Department Staff, Based on The Routine Section That Includes The Presentation of Pamphlets and Face-to-Face Training. Anthropometric Examinations (Including Measurements of Body Mass Index, Midarm Circumference, Tricuspid Skin Fold Thickness and Waist Circumference) and Biochemical (Including: Hemoglobin, Albumin, Transferrin, Reactive Protein C, Number of lymphocytes), To See The Result of Training in Nutritional Indices in Patients With Ileostomy, in Two Stages Gets The First Stage, The Day Before The Surgery, is Considered in The Pre-intervention Phase, and The Second Stage is Three Weeks After The Surgery and The Insertion of The Ileostomy.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mehrdad Salehi
Street address
Imam Khomeini Hospital Complex,Dr Gharib st, End of Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Web page address
http://ikhc2.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Deputy Director of Researche And Technology University of Iran
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Web page address
http://iums.ac.ir/index.php?sid=1
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Ghazaleh Akhoondian
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
akhondian.gh@tak.iums.ac.ir
Web page address
http://fnm.iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghazaleh Akhoondian
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St
City
tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
akhondian.gh@tak.iums.ac.ir
Web page address
http://fnm.iums.ac.ir/en?sid=31
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghazaleh Akhoondian
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
akhondian.gh@tak.iums.ac.ir
Web page address
http://fnm.iums.ac.ir/fa?sid=31
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total Non-identifiable Data, The Potentialof The People Sharing
When the data will become available and for how long
Start Access 2018/8
To whom data/document is available
Professors and Students
Under which criteria data/document could be used
-
From where data/document is obtainable
-akhondian.gh@tak.iums.ac.ir
What processes are involved for a request to access data/document
Request Via E-mail and Respond by E-mail Within one Week to DO.