This quasi-experimental study will be done to determine the effect of self-care education on quality of life in women with gestational diabetes. The main inclusion criteria will be women with a singleton pregnancy associated with gestational diabetes without having physical and mental illnesses will referre to an endocrinology clinic in Karaj city. They will be randomly divided into in 4 groups of 60 persons (240 persons). Before intervention, for each of the four groups, information of subjects will gather with individual-fertility questionnaire and quality of life for gestational diabetes questionnaire. Then for first (patients will be treated with diet plus self care education) and third (patients will be treated with insulin plus self care education) groups, patients are companied in four 45-minute sessions weekly for a month’s in self care education program. Then the patients for two months will follow with telephone counseling every two weeks and visiting them at the end of each month in the center for sampling and holding a question and answer session. Second (patients will be treated with diet without self care education) and fourth (patients will be treated with insulin without self care education) groups will receive all routine care but not get any self care education. Quality of life for all patients will evaluate again 3 months after by the investigator and finally the quality of life before and after the intervention in the different groups will be compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406022892N3
Registration date:2014-06-26, 1393/04/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-26, 1393/04/05
Registrant information
Name
Mani Mirfeizi
Name of organization / entity
Islamic Azad University Karaj branch
Country
Iran (Islamic Republic of)
Phone
00982614403254/ 00982614182580/ 00982614455635
Email address
mani@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Islamic Azad University, Karaj branch
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of self care education on quality of life of women with gestational diabetes
Public title
The effect of educational intervention on quality of life in pregnant women with diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women with diagnosis of gestational diabetes and singleton pregnancies; disease is diagnosed by a specialist physician ; not suffering from any physical or mental diseases condition according to his medical records and statements ; No alcohol, smoking and drugs ; Wanted pregnancies ; Less than one month from the time of diagnosis of gestational diabetes is made ; Pregnant women with gestational diabetes are treated with human insulin (not analog); Maternal gestational age 20-24 weeks at the time of study entrance ; Pregnant women before and during the study has not followed a specific exercise program.
Exclusion criteria: Mother is suffering from diagnosed diabetes before pregnancy; Multiple pregnancies; Patients are component medical or paramedical groups.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
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
Ethics Committee of Islamic Azad University Karaj Branch
Street address
Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj
City
Karaj
Postal code
Approval date
2014-03-12, 1392/12/21
Ethics committee reference number
0065
Health conditions studied
1
Description of health condition studied
Diabetes mellitus in pregnancy
ICD-10 code
024.4
ICD-10 code description
Diabetes mellitus arising in pregnancy
Primary outcomes
1
Description
Quality of Life
Timepoint
Baseline (pre-intervention) and after three months
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In interventional group: The first and third groups, patients with a family member who help the most in his life are companied in four 45-minute sessions weekly for a month's in self care education program. In each session in a maximum 6 patients and 6 person helping the patient will attend. At the end of each self care education session will be provided booklet or pamphlet (the total of two booklets and four pamphlets), to the patients depending on the treatment. Educational pamphlets and booklets containing all of the above training sessions, so patient it should be remembered and used. Self care education program is prepared by reading books and articles, according to the educational needs and literacy of patients. Teaching methods will be consisting of direct methods (combination of face-to-face, lectures, group discussions and the use of educational films) and indirect methods (pamphlets and educational booklets). Implementation of this education will be done by Internal Medicine (Dialectologist), dietitian and research assistant. Patients will be followed in the two months after the training sessions, by telephone counseling every two weeks by a researcher individually and refer them to the end of each month to sampling centers for verbal question and answer session.
Category
Lifestyle
2
Description
In control group:
In second and fourth group (control) patients received routine prenatal visits by Diabetologist and gynecologist or obstetrics for getting all necessary care routine but not get any self care education like as intervention group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic of Dr. Mani Mirfeizi
Full name of responsible person
Street address
Omid physicians clinic, Beheshti Avenue, Karaj
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University of Karaj Branch
Full name of responsible person
Dr. Ahmad Jahan Latibary
Street address
Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj
City
Karaj
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, Islamic Azad University of Karaj Branch
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
Alborz University of Medical Sciences
Full name of responsible person
Zahra Mehdizadeh Tourzani
Position
Faculty Member
Other areas of specialty/work
Street address
Alborz University of Medical Sciences, Nursing and Midwifery Faculty, Katouiezadeh Street, 45 Meters Golshahr, Karaj
City
Karaj
Postal code
Phone
+98 26 3445 5635
Fax
Email
z_mehdizadeh_t@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Karaj Branch
Full name of responsible person
Dr. Mani Mirfeizi
Position
Professor of Internal Medicine
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Islamic Azad University, Karaj Branch, Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj
City
Karaj
Postal code
Phone
+98 26 3445 5635
Fax
Email
mani@kiau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Karaj Branch
Full name of responsible person
Dr. Mani Mirfeizi
Position
Professor of Internal Medicine/ Faculty Member
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Islamic Azad University, Karaj Branch, Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj
City
Karaj
Postal code
Phone
00
Fax
Email
mani@kiau.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)