objective:
Determine the effect of self-care education program on mental health and self-esteem in patients with type 2 diabetes.
Designing :
This is a non-randomized clinical trial study with pre-test and post-test will be done with the control group.Among the 78 patients with type 2 diabetes are selected as the sample are considered.
procedure:
This will be the all of the samples (control and test), questionnaire of mental health and self-esteem In the first meeting with the investigator, will be completed.Type II diabetes self-management training programs through face-to-face intervention, speech and question and answer,In three one-hour sessions over three weeks (three weeks will be consecutive.) For the experimental group, will be held.During the intervention control group, the intervention will be taken.Self-esteem and mental health of patients and control groups, one month after the training, By Goldberg mental health questionnaire and Rosenberg self-esteem questionnaire, measured And mental health and self-esteem at the end of the two groups will be studied and analyzed.
Inclusion criteria: 1. whether people with type 2 diabetes, according to the treating physician; 2. 40-60 years of age;3 - the ability to perform self-care company continued
exclusion criteria: 1.Lack of patient consent to participate in research continue 2 absence In a training session interventions: type II diabetes self-management education program .The primary outcome variable: mental health and self-esteem. No secondary outcome.
General information
Acronym
not
IRCT registration information
IRCT registration number:IRCT2017030932511N1
Registration date:2017-03-09, 1395/12/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-09, 1395/12/19
Registrant information
Name
mahnaz shabani
Name of organization / entity
Iran University of Medical Sciences. nursing school
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2885
Email address
mahnaz.shabani2013@gmail.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences Nursing school
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-04-14, 1396/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education on mental health and self-care in type II diabetic patients.
Public title
The effect of self-care education on mental health and self-esteem
Purpose
Prevention
Inclusion/Exclusion criteria
.Inclusion criteria:1 infected subjects with type 2 diabetes, according to the treating physician; 2. 40-60 years of age; 3. monthly referral of patients to the health center city of Amol;4. Sign in cases of mental illnesses 5. The ability to self care(Lack of upper limb disabilities or lack of disease, orthopedic (musculoskeletal) and Rheumatology upper limb ...).Exclusion criteriaLack of patient consent to participate in the continuing investigation 2. sudden withdrawal of one or more persons Of subjects during the study and to participate in training programs, for reasons such as relocating Location of the city of Amol 3 The incidence of some side issues, family etc. or pleasant consequences for one or more subjects 4 do not Participate in a training session.
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
not
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
iran medical science university
Street address
tehran.hemmat free way.side of milad tower
City
tehran
Postal code
IR.IUMS.REC.1395.921
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.IUMS.REC 9211196244.1395
2
Ethics committee
Name of ethics committee
iran medical science university
Street address
tehran.hemmat free way.side of milad tower
City
tehran
Postal code
1449614535
Approval date
2016-02-28, 1394/12/09
Ethics committee reference number
IR.IUMS.REC 9211196244.1395
Health conditions studied
1
Description of health condition studied
Type 2 of diabetes mellitus
ICD-10 code
E 14
ICD-10 code description
Unspecified diabetes mellitus
Primary outcomes
1
Description
self steem
Timepoint
before and 1 mounth after of intervention
Method of measurement
RSES questionnair
2
Description
sanity
Timepoint
before and 1 mount after of intervention
Method of measurement
GHQ -28- questionaire
Secondary outcomes
empty
Intervention groups
1
Description
The control group was not performed and only at the end will receive a training manual.
Category
Other
2
Description
Type II diabetes self-management training programs through face-to-face intervention, speech and question and answer, in three one-hour sessions over three weeks (three weeks will be consecutive.) For the experimental group, will be held.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
mofatteh clinic
Full name of responsible person
maryam qobadi raad
Street address
mazandaran.amol.28th aftab.mofatteh clinic
City
amol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
the assistance of research of University of Medical Sciences
Full name of responsible person
seyyed ali javad moosavi
Street address
Besides Milad Tower proper task of promoting martyr Hemmat Highway of Medical Sciences
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
the assistance of research of 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
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
fariba nasiri ziba
Position
Master of nursing
Other areas of specialty/work
Street address
Tehran Nursing and Midwifery Iran .vlysr St. martyr Yassami .danshkdh
City
tehran
Postal code
1449614535
Phone
+98 21 8888 2885
Fax
+98 21 8888 2885
Email
fariba_nz@yahoo.com
Web page address
www.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery in Iran
Full name of responsible person
fariba nasiri ziba
Position
Master of nursing
Other areas of specialty/work
Street address
Tehran Nursing and Midwifery Iran .vlysr St. martyr Yassami .danshkdh
City
tehran
Postal code
1449614535
Phone
+98 21 8888 2885
Fax
+98 21 8888 2885
Email
fariba_nz@yahoo.com
Web page address
www.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery in Iran
Full name of responsible person
mahnaz shabani
Position
Masters student
Other areas of specialty/work
Street address
Age .kh martyr Yassami .danshkdh Nursing Iran
City
tehran
Postal code
1449614535
Phone
+98 21 8888 2885
Fax
+98 21 8888 2885
Email
mahnaz.shabani2013@gmail.com
Web page address
www.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)