Protocol summary

Study aim
The purpose of this research is to investigate the effectiveness of psychological education of mothers of children with type 1 diabetes on HbA1c, self-management, quality of life and social support of children, so that if this intervention and the useful protocol found in foreign articles are effective in helping Children with type 1 diabetes in our country benefit.
Design
The current research is a clinical trial (RCT) that is conducted with pre-test, post-test and control group and randomization.
Settings and conduct
Both experimental and control groups were provided with a set of educational pamphlets, which were taught and reviewed during eight face-to-face briefings. The protocol, which is based on foreign articles, will receive training at the center of endocrinology and metabolism of Sedige Tahereh, Isfahan.
Participants/Inclusion and exclusion criteria
The inclusion criteria for this study include children with type 1 diabetes with an age range of 8 to 12 years, and 6 months have passed since the diagnosis of their disease, the absence of accompanying psychiatric disorders in children, and having minimal literacy in mothers, as well as willingness to cooperate. Exclusion criteria include failure to complete questionnaires correctly or failure to regularly participate in psychological training sessions.
Intervention groups
Psychoeducation is the process of educating clients about the nature of illness, including its cause, progression, consequences, prognosis, treatment, and alternatives.
Main outcome variables
The score of the diabetes self-management questionnaire, the score of the quality of life questionnaire for children aged 8 to 12 years, the score of the children's social support scale questionnaire, the score of the children's behavioral questionnaire, the HbA1C score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221227056942N2
Registration date: 2023-10-08, 1402/07/16
Registration timing: prospective

Last update: 2023-10-08, 1402/07/16
Update count: 0
Registration date
2023-10-08, 1402/07/16
Registrant information
Name
Mahdi Mirpourian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3331 6138
Email address
mhdmirpourian@res.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effectiveness of psychoeducation for mothers of children aged 8 to 12 years with type 1 diabetes on HbA1c, self-management, quality of life and social support of children.
Public title
Assessment of the effectiveness of psychoeducation for mothers of children aged 8 to 12 years with type 1 diabetes on HbA1c, self-management, quality of life and social support of children.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with type 1 diabetes aged 8 to 12 years 6 months have passed since the diagnosis of their disease Absence of concomitant psychiatric disorder in children having minimum reading and writing literacy in mothers Willingness to cooperate
Exclusion criteria:
Failure to complete questionnaires correctly Lack of regular participation in psychological training sessions
Age
From 8 years old to 12 years old
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
The sampling method is random, and in the first stage, the sampling method was consecutive, and then in the random sampling method, double blocks were used for random allocation. Then the members of each block of two were sorted according to the national code and the table of random numbers was used in such a way that for numbers 0 to 4 the first person was moved to group 1 and the second person to group 2 and for numbers 5 to 9 people The second person was transferred to group 1 and the first person was transferred to group 2, and this work continued until the sample size was sufficient, and after that, the table of random numbers was used again to determine groups 1 and 2, in such a way that for numbers 0 to 4 groups of psychological training group 1 and control group group 2 were determined and for numbers 5 to 9 psychological training group group 2 and control group group 1 were selected
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
EthicS Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hazar Jerib Street, Isfahan
City
Isfehan
Province
Isfehan
Postal code
8174673461
Approval date
2023-10-02, 1402/07/10
Ethics committee reference number
IR.MUI.MED.REC.1402.239

Health conditions studied

1

Description of health condition studied
type 1 diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus

Primary outcomes

1

Description
Diabetes self-management questionnaire score
Timepoint
Before the intervention, immediately after the intervention and 3 months after the intervention
Method of measurement
Diabetes self-management questionnaire

2

Description
Questionnaire of the quality of life of children aged 8 to 12 years
Timepoint
Before the intervention, immediately after the intervention and 3 months after the intervention
Method of measurement
Questionnaire of the quality of life of children aged 8 to 12 years score

3

Description
Child and adolescent social support scale score
Timepoint
Before the intervention, immediately after the intervention and 3 months after the intervention
Method of measurement
Child and adolescent social support scale

4

Description
Child behavior questionnaire score
Timepoint
Before the intervention, immediately after the intervention and 3 months after the intervention
Method of measurement
Child behavior questionnaire

5

Description
hba1c level
Timepoint
Before the intervention, immediately after the intervention and 3 months after the intervention
Method of measurement
blood test

Secondary outcomes

empty

Intervention groups

1

Description
Control group: A series of educational pamphlets with the content of the importance of blood sugar regulation and the warning signs of hypoglycemia and hyperglycemia have been provided, and during eight face-to-face orientation sessions, the contents of these pamphlets have been taught and reviewed, as well as the daily experiences and challenges of these mothers regarding their children's diabetes in the presence of the therapist. And without providing specific training, a group discussion will take place.
Category
Placebo

2

Description
Intervention group: Intervention group: in the experimental group of mothers of diabetic children, in addition to the cases mentioned in the control group, in two psychological training groups of 12 people during 8 weekly one-hour sessions according to the protocol that was used based on foreign articles, in the Siddigeh Endocrine and Metabolism Center Tahereh Isfahan received training. The general content of the training sessions includes: first session: introduction to diabetes and the type of intervention - second session: teamwork and family communication - third session: blood sugar monitoring and medication use - fourth session: problem solving skills - The fifth session: Avoiding perfectionism and setting realistic goals - The sixth session: The importance of weight management - The seventh session: Reducing the feeling of exhaustion and gaining social support - The eighth session: Ways to stay motivated.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Sedigeh Tahereh Endocrine and Metabolism Research Center
Full name of responsible person
Dr Mansoor Siavash
Street address
Endocrine and Metabolism Research Center, Hazrat Sediqeh Tahira Educational, Therapeutic and Research Complex, Khorram St. ,Republic Square, Isfahan
City
isfehan
Province
Isfehan
Postal code
81876-98191
Phone
+98 31 3335 9933
Email
emrc@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
DR Gholamreza Asgary
Street address
Isfahan University of Medical Sciences , Hazar Jarib Street, Isfahan
City
isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
edo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Reza Bagherian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street, Isfahan
City
isfehan
Province
Isfehan
Postal code
8174673461
Phone
009832371103
Email
bagherian@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Amrollah Ebrahim
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street, Isfahan
City
isfehan
Province
Isfehan
Postal code
8174673461
Phone
009832371103
Email
amrollahebi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahdi Mirpourian
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street, Isfahan
City
isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mhdmirpourian@gmail.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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