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Effects of audio-visual training on attitude and self efficacy toward marriage in patients with type one diabetes

Protocol summary

Summary
This study is a randomized clinical trial, on 100 individuals with type I diabetes subjects characteristics (marital status, access to computer literacy in the use of computers, passing at least one year of diabetes type, lack of the disease with physical and mental known other than diabetes) will have, will do. Exclusion criteria: not cooperate feet samples, out of reach, is having a physical or mental illnesses. Data questionnaire. The questionnaire consisted of two parts. The first part of the demographic characteristics of participants, the second part is a self-made questionnaire. Intervention, including education (audio - video) to improve vision in patients with type I diabetes patients and increase self-efficacy in relation to the impact unfit to marry this person is in the form of a CD designed and they are placed in the intervention group. First, a researcher with the association of psychiatrists Gabric or Iranian Diabetes Society coordinated and he will be asked about various aspects of the program outlined in type I diabetes, talk. educational content therapist include how good compatibility with type I diabetes, how diabetes ordinary life, the importance of marriage in the mental health challenges of marriage and type I diabetes, type I diabetes patients how to cope with problems related to marriage is (Married, sex, relationship with spouse, etc.). And students about the summary of the physiology of type I diabetes, methods of optimal control, people with diabetes how to cope with problems related to pregnancy and newborn (associated with infertility, diabetes, diabetic complications in pregnancy, inheritance, children, breast-feeding babies, etc.) education offers. Questionnaire 6 weeks after the intervention, both groups are again available. At the end of the data collection and efficacy attitude towards marriage and intervention groups compared to control. To describe data, descriptive statistics and statistical tests to determine the association of t-test, chi-square and Mann-Whitney U will be used.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT201405105918N6
Registration date: 2014-06-24, 1393/04/03
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-06-24, 1393/04/03
Registrant information
Name
Seyed Fatemeh Vasegh Rahimparvar
Name of organization / entity
Tehran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
vaseghrh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
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
Effects of audio-visual training on attitude and self efficacy toward marriage in patients with type one diabetes
Public title
Effects of audio-visual training on marriage in patients with type one diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Single, access to a computer with the use of computer literacy, passing at least one year of diabetes type, lack of physical and mental diseases are known Other from diabetes. Exclusion criteria: non-cooperation, death cases, out of reach, having a physical or mental illnesses.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Ethical Review Commiitee of Tehran University of Medical Sciences
Street address
Keshavarz BLD, Ghods street, Central building of Tehran University of Medical Sciences, 6th floor
City
Tehran
Postal code
Approval date
2014-05-25, 1393/03/04
Ethics committee reference number
484/130/د/93

Health conditions studied

1

Description of health condition studied
Insulin-dependent diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Attitude
Timepoint
6 week
Method of measurement
Questionnaire

2

Description
Self-Efficacy
Timepoint
6 week
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Education CD player
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Diabetes Scociety
Full name of responsible person
Iran, Islamic Republic Of
Street address
46 Ramin Malakooti Street , Patris Lomumba
City
Tehran

2

Recruitment center
Name of recruitment center
Endocrinology & Metabolism Research Institute Tehran University Of Medical Sciences
Full name of responsible person
Dr. Nika Mojahed
Street address
5th floor, Dr.Shariati hospital, North Kargar avenue
City
Tehran

3

Recruitment center
Name of recruitment center
Diabetes Association Gabric
Full name of responsible person
NGO
Street address
Vanak Square - Gandhi Avenue North - St. Sharif brothers - No. 22
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Scinces
Full name of responsible person
Abbas Hoshmand Behabadi
Street address
Faculty of Nursing and Midwifery,Tohid SQ, Nosrat ST
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran University of Medical Scinces
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 Siences
Full name of responsible person
Shiva Khodarahmy
Position
Graduate Student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat St, Tohid Sq
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
shiva_khodarahmi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Siences
Full name of responsible person
Seyed Fatemeh Vasegh Rahimparvar
Position
Instructor
Other areas of specialty/work
Street address
Nosrat St,Tohid Sq, Faculty of Nursing and Midwifer
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
vaseghrh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Siences
Full name of responsible person
Seyed Fatemeh Vasegh Rahimparvar
Position
Instructor
Other areas of specialty/work
Street address
Nosrat St,Tohid Sq, Faculty of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
vaseghrh@tums.ac.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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