Effect of Stress Management based Self-care Counseling on Glycemic control l in Women with Gestational Diabetes Mellitus: A Controlled Intervention Study
Determining the effect of self-care counseling based on stress management on blood sugar control of women with gestational diabetes
Design
Randomized controlled clinical trial
Settings and conduct
Women diagnosed with gestational diabetes referring to Shahadai Behshahr Hospital, who meet the study inclusion criteria, are randomly assigned to two intervention and control groups. In the intervention group, in addition to receiving prenatal care, women receive a self-care counseling protocol based on stress management in 8 sessions of 45 to 50 minutes once a week virtually through WhatsApp in the form of clips, text and video. The control group only received routine care for women with gestational diabetes according to national guidelines. Before and immediately after the intervention, fasting blood sugar and glycosylated hemoglobin and diabetes self-care behavior questionnaires, depression, anxiety, stress scale (DASS) and pregnancy-specific stress questionnaire were completed by them and compared.
Participants/Inclusion and exclusion criteria
The inclusion criteria include: women diagnosed with gestational diabetes (fasting blood sugar more than 92 mg/dL) with a singleton pregnancy at a gestational age of 20 to 30 weeks.
Exclusion criteria include: currently using other psychotherapy services, exposed to stressful situations such as the loss of a family member, high-risk pregnancy (such as pre-eclampsia, stillbirth, and premature birth).
Intervention groups
Recipient of eight training sessions self-care counseling based on stress management on blood sugar control of women with gestational diabetes
Main outcome variables
Changes in mean fasting blood sugar and Hb A1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200122046228N5
Registration date:2024-03-16, 1402/12/26
Registration timing:retrospective
Last update:2024-03-16, 1402/12/26
Update count:0
Registration date
2024-03-16, 1402/12/26
Registrant information
Name
Fatemeh Nasiri Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3230 2823
Email address
f.nasiri@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-11, 1401/04/20
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
2022-07-11, 1401/04/20
Actual recruitment end date
2023-03-21, 1402/01/01
Trial completion date
2023-10-08, 1402/07/16
Scientific title
Effect of Stress Management based Self-care Counseling on Glycemic control l in Women with Gestational Diabetes Mellitus: A Controlled Intervention Study
Public title
Effect of Stress Management Counseling on Glycemic control l in Women with Gestational Diabetes Mellitus: A Controlled Intervention Study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
have written informed consent
have the ability to use a mobile phone and Social messengers
Internet access
have a gestational age of 20 to 30 weeks
have been diagnosed with gestational diabetes ( Fasting Blood Sugar [FBS] greater than or equal to 92 mg/dl ).
At least a third year of middle school
No current psychotherapy services
Lack of a history of psychiatric disorder
Exclusion criteria:
Exposed to stressful situations such as the loss of a family member.
Obtaining a very high score on the depression anxiety stress scales (DASS)
If a high-risk pregnancy occurs (such as pre-eclampsia, dead fetus, and premature birth).
Unwillingness to continue participation in the study
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
After checking inclusion and exclusion criteria, participants are allocate randomly into two groups by permuted block randomization method. The block size is 4 and by using the statistical software, 4 part blocks will be produced 19 times.Using this randomly generated list, participants are divided into two groups of Self-care Counseling (N=38) and only antenatal usual care (N=37).
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 Babol University of Medical Sciences
Street address
Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2022-07-11, 1401/04/20
Ethics committee reference number
IR.MUBABOL.HRI.REC.1401.096
Health conditions studied
1
Description of health condition studied
Stress management based self-care counseling, Glycemic Control, Gestational Diabetes Mellitus
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in pregnancy, Gestational diabetes mellitus
Primary outcomes
1
Description
mean change in fasting blood glucose test
Timepoint
before the intervention and immediately after the end of the last intervention session
Method of measurement
The level of fasting blood glucose was measured using a Hitachi 912 auto-analyzer made in Japan.
2
Description
mean change in Hb A1C (glycated hemoglobin) test
Timepoint
before the intervention and immediately after the end of the last intervention session
Method of measurement
The level of Hb A1c (glycated hemoglobin) test was measured using a Hitachi 912 auto-analyzer made in Japan.
Secondary outcomes
1
Description
Diabetes Self-Care Activities
Timepoint
Before and immediately after the end of the last intervention
Method of measurement
The Summary of Diabetes Self-Care Activities (SDSCA) questionnaire
2
Description
The Depression Anxiety and Stress
Timepoint
Before and immediately after the end of the last intervention
Method of measurement
The Depression Anxiety and Stress Scale (DASS)
3
Description
pregnancy-specific stress
Timepoint
Before and immediately after the end of the last intervention
Intervention group: The GDM women in this group at 20 to 30 weeks of pregnancy in addition to receiving prenatal care, receive Stress management-based self-care counseling protocol, 8 sessions , 45-50 minutes, once a week. The content in each session consisted of 2 parts. One part is gestational diabetes self-care training and the second part is stress management skills. Session 1: Definition of diabetes in pregnancy, its prevalence and risk factors, screening methods for diabetes in pregnancy and the consequences of diabetes. For mental health, conceptualization of the model, acquaintance with automatic thoughts of stress in diabetes. Session 2: Definition of self-care, types of self-care and its benefits, relationship between self-care and diabetes, and conceptualizing the ABC of stress in diabetes (Activating event, Belifes. Consequence). Session 3: Healthy diet in diabetes, and cognitive concept in diabetes stress (reassurance 1). Session 4: Physical activity and diabetes, cognitive restructuring in diabetes stress (reassurance 2). Session 5: How to monitor blood sugar and inject insulin in patients with gestational diabetes, teaching hypoglycemia symptoms and related solutions, types of dealing with stress and problem-oriented intervention (reassurance 3). Session 6: Smoking and its effect on diabetes, Emotional intervention and diabetic stress (reassurance 4). Session 7: drugs in diabetes, Problem Solving Skills (reassurance 5). Session 8: Summarizing the contents and answering the questions, Summary of the model and prevention of recurrence.
Category
Treatment - Other
2
Description
Control group:This group of women with gestational diabetes received only routine antenatal care (AUC) by a health care provider at the prenatal clinic of Shahada Hospital, such as weight control, vital signs, routine pregnancy tests, and periodic monitoring of maternal and fetal health. they receive according to the guidelines of "integrated maternal health care" during pregnancy and do not receive the stress-based self-care counseling protocol.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital in the city of Behshahr
Full name of responsible person
Atefeh Bagheri Tirtashi
Street address
Shahid Hashminejad Boulevard, Shahada Hospital
City
Behshahr
Province
Mazandaran
Postal code
4851613185
Phone
+98 912 003 5876
Email
a.bagheri1360@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajab Nia
Street address
Vice-Chancellor's Office for Research, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4720
Email
ramazan69@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
دانشگاه علوم پزشکی بابل
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
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Nasiri Amiri
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
nasiri_fa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Nasiri-Amiri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
nasiri_fa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Nasiri Amiri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
nasiri_fa@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available