The purpose of this study will be to determine the effect of stress management counseling on stress management and quality of life in women with gestational diabetes. The research environment will include all health centers in Hamadan city. The study population will be included all pregnant women with gestational diabetes referred to Hamadan Health Center. In this study, 59 people in each of the test and control groups will be selected among people with inclusion criteria. The Hamadan Health Centers will be divided into 4 geographical areas, and 3 centers will randomly be selected from each areas. From a total of 12 Health Centers, 6 will be assigned to the experimental group and 6 to the control group randomly. The intervention group has 4 group counseling sessions on stress management. Counseling will take place in the form of GATHER counseling stages in 45-60 minutes (one weekly). The level of stress management and quality of life in the research samples will be measured before and one month after the consultation. Finally, the data wiil be evaluated using descriptive and analytical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017062010635N3
Registration date:2017-09-02, 1396/06/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-02, 1396/06/11
Registrant information
Name
Soodabeh Aghababaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
aghababaii@yahoo.com
Recruitment status
Recruitment complete
Funding source
Hamadan Medical University
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-10-07, 1396/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of stress management consulting on stress and quality of life of pregnant women with gestational diabetes attending to health care centers
Public title
Effect of stress management consulting on stress and quality of life of pregnant women with gestational diabetes attending to health care centers
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Gestational Diabetes; Not having other underlying illnesses; Single pregnancy; Gestational age 28- 32 weeks; Getting score 150 from stress test; Having primary and higher education; Not having a history of gestational diabetes; Only treated with insulin; Do not use the medicine to reduce stress.
Exclusion criteria:
Not attending more than one class of training sessions; Major stressful events during research (serious illness of spouse and child, death of one of loved ones; accident, severe family disorder, divorce, migration) during study; Unwillingness to continue to study; Occurrence of pregnancy-related complications.
Age
No age limit
Gender
Female
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
Random sampling method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Ave, Hamadan medical university, Hamadan, Iran.
City
Hamadan
Postal code
Approval date
2017-07-06, 1396/04/15
Ethics committee reference number
IR.UMSHA.REC.1396.254
Health conditions studied
1
Description of health condition studied
Gestational Diabet
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
Stress management
Timepoint
Before and after intervention
Method of measurement
Harry's Stress Questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before and after intervention
Method of measurement
Quality of Life Questionnaire
Intervention groups
1
Description
The intervention group will have 4 group counseling sessions on stress management.
Category
Lifestyle
2
Description
There is no intervention in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Medical University
Full name of responsible person
Aghababaei Soodabeh
Street address
Sahid Fahmideh Ave, Hamadan Medical University, Hamadan, Iran.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Aghababaei Soodabeh
Street address
Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan Medical University
Full name of responsible person
Aghababaei Soodabeh
Position
PhD/ Academic member
Other areas of specialty/work
Street address
Sahid Fahmideh Ave, Hamadan medical university, Hamadan , Iran.
City
Hamadan
Postal code
Phone
+98 81 3838 0150
Fax
Email
aghababaii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamdan Medical University
Full name of responsible person
Aghababaei Soodabeh
Position
PhD
Other areas of specialty/work
Street address
Shahid Fahmideh Ave, Hamadan Medical Sceinces University, Hamadan, Iran.
City
Hamadan
Postal code
Phone
+98 81 3838 0150
Fax
Email
aghababii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan Medical University
Full name of responsible person
Aghababaei Soodabeh
Position
Academic member/ PhD
Other areas of specialty/work
Street address
Sahid Fahmideh Ave, Hamadan Medical University, Hamadan, Iran
City
Hamadan
Postal code
Phone
+98 81 3838 0150
Fax
Email
aghababaii@yahoo.com
aghababaei@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)