Evaluation the effect of maternal stress management on blood sugar in children with diabetes
Design
Clinical Trial with a Control group, with Parallel, non-blind, Simple Randomized groups, on 48 mothers and their children. The Orib Coin model was used for randomization.
Settings and conduct
Location: Amirkabir Teaching Hospital, Arak.
There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers with diabetic children, ability to read and write.
Non inclusion criteria: dissatisfaction of participants, being a single supervisor.
Intervention groups
Intervention group: Mothers of children with type 1 diabetes for whom a stress management training workshop is held.
Control group: Mothers of children with type 1 diabetes for whom no stress management workshop is held.
Main outcome variables
Baby Blood Sugar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210110049988N1
Registration date:2021-06-24, 1400/04/03
Registration timing:retrospective
Last update:2021-06-24, 1400/04/03
Update count:0
Registration date
2021-06-24, 1400/04/03
Registrant information
Name
Masoomeh Adavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3413 3061
Email address
daneshkadeha@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Stress Management Workshop for Mothers of Children With Type 1 Diabetes on Their Children's Blood Sugar
Public title
The Effect of Stress Management on Blood Sugar
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers' inclusion criteria: Having a child with type 1 diabetes who is at least three months old at the time of diagnosis, willingness to participate in reading, literacy.
Inclusion criteria for children: Having type 1 diabetes that is at least three months after diagnosis.
Exclusion criteria:
Criteria for non-inclusion of mothers: acute and chronic disorders (with emphasis on psychiatric disorders); Being a single parent, the existence of another crisis in the family.
Criteria for non-inclusion of children: history of other acute and chronic diseases in the past, co-occurrence of other acute and chronic diseases at the same time, presence of congenital or chromosomal disorders
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization - Easy sampling of diabetic children, type 1 diabetes referred to Amirkabir Hospital in Arak and doctor's office (Dr. Mohammad Ahangar Davoodi) in 2021, 48 people were randomly selected and divided into two groups using the Orib Coin method.
In the Orib Coin method, a dice and a coin are required. To place people in the control and intervention groups, first a coin is thrown, if it is a line, a dice is thrown, and if it is 1 to 3, the person is placed in the control group. For the second time in the intervention group, the dice that were thrown must be between 3 and 4 in order for the person to be in the intervention group. In the same way, 48 people will be divided until the end.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Shahid Shiroodi
City
arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.ARAKMU.REC.1399.341
Health conditions studied
1
Description of health condition studied
Type 1 diabetes
ICD-10 code
E10.9
ICD-10 code description
Type 1 diabetes mellitus without complications
Primary outcomes
1
Description
Baby blood sugar
Timepoint
3 monthsBefore starting the study. After completing the stress management classes and a month later.
Method of measurement
Glucometer
Secondary outcomes
1
Description
Mothers' stress
Timepoint
Before the start of the study, after completing the stress management classes, and a month later
Method of measurement
Cohen Perceived Stress Questionnaire
Intervention groups
1
Description
Intervention group: Mothers with diabetic children, stress management workshop, during 8 face-to-face sessions, PowerPoint presentation and educational video
Category
Rehabilitation
2
Description
Control group: Control group: Mothers with diabetic children, without stress management workshop
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-Kabir Hospital, Arak
Full name of responsible person
Masoumeh Adavi
Street address
Shahid Shiroodi Street
City
Arak
Province
Markazi
Postal code
3819867331
Phone
+98 86 3313 4715
Fax
+98 86 3313 2510
Email
daneshkadeha@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Street address
Alam al-Huda street; Shahid Shiroodi street
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
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
Arak University of Medical Sciences
Full name of responsible person
Masoumeh Adavi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Atlasi
City
Arak
Province
Markazi
Postal code
3819867331
Phone
+98 86 3413 3061
Email
adavimasoomeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Ganja
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Faculty of Nursing
Street address
Alam al-Huda street; Shahid Shiroodi street
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
pooran.ganjeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masoumeh Adavi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Instructor of the School of Nursing
Street address
Atlasi street
City
Arak
Province
Markazi
Postal code
3819867331
Phone
+98 86 3413 3061
Email
adavimasoomeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information such as age, mean blood sugar in children before and after educational interventions and the effect of stress management workshop on stress and blood sugar in children
When the data will become available and for how long
Access period starts from 1400
To whom data/document is available
Researchers working in academic institutions and hospitals
Under which criteria data/document could be used
Provided with proper and ethical use to reduce the stress of mothers with children with diabetes and referral to information is free access.
From where data/document is obtainable
Masoumeh Adavi, 09189596008
What processes are involved for a request to access data/document
Send first and last name, field of study, university of study, type of requested data, via SMS