Protocol summary

Study aim
Comparison of the effect of mother and child education using teachback and multimedia methods on the average score of self-care behaviors in children with type 1 diabetes
Design
A clinical trial with a control group, with 2 parallel groups, without blinding, randomized on 45 patients.
Settings and conduct
This research will be conducted on children with type 1 diabetes and their mothers. Patients are selected according to the sample size by simple random sampling and according to the entry criteria and obtaining a score of less than 47 from Tobert and Glasgow's diabetes self-care questionnaire (2002), then the patients are divided into three groups (two intervention groups and one control group). Placed. Due to the uncertainty of the list of patients and the gradual admission of DKA patients in the PICU department, the first patient who meets the entry criteria will be placed in the control group, the second patient in the teachback group, and the third patient in the multimedia group, and this arrangement will continue until the end of sampling. he does
Participants/Inclusion and exclusion criteria
Inclusion criteria Child age 6-12 Obtaining a score less than 47 of Tobert Voglasko's diabetes self-care questionnaire (2002) Exclusion criteria Unwillingness to participate in the study or Death
Intervention groups
Teachback instruction method as the intervention Multimedia teaching method as the control
Main outcome variables
Self-care behaviors in type 1 diabetic children

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231128060208N1
Registration date: 2024-03-02, 1402/12/12
Registration timing: registered_while_recruiting

Last update: 2024-03-02, 1402/12/12
Update count: 0
Registration date
2024-03-02, 1402/12/12
Registrant information
Name
Rahimeh Zelhagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 033 0375
Email address
rahime.zelhagh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of teaching mother and child together using the teach-back method with the multimedia method, on self-care behaviors in children with type 1 diabetes.
Public title
Comparing the effect of teaching mother and child together using the teach-back method with the multimedia method, on self-care behaviors in children with type 1 diabetes.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
3. 6 months to a year have passed since the diagnosis of diabetes Getting a score less than 47 from Tobert and Glasgow's diabetes self-care questionnaire (2002) Diagnosing type 1 diabetes in a child by a doctor Not teaching the child about diabetes during the last month Absence of the child's parents in the medical science group Access and ability of the child or a family member. to electronic devices such as phones or laptops Child age 6-12 The child's absence of physical and mental illness other than diabetes (by examining the doctor's case and medical history) Consciousness level should be based on Glasgow 15 criteria Having a desire to participate in research The mother should not be responsible for taking care of any patient other than diabetes in the family The possibility of calling the child's mother Mother's literacy The absence of the mother suffering from mental, nervous or other known chronic diseases (according to the history taken) Having a mother's phone or laptop and the ability to work with it
Exclusion criteria:
Creating physical problems in the mother or child that prevents self-care Withdrawal of mother and child from participating in the study Non-cooperation of the client Participation in self-care training sessions of other workshops or researches Death of mother or child
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
By simple random method In order to randomly assign the groups, 45 sheets of the same shape and size are cut and written on 15 sheets of the control group, 15 sheets of the teachback group and 15 sheets of the multimedia group, and the sheets are folded and put in a container and mixed. to be Upon admission of each patient, a sheet is removed from the container to determine the group and the patient's group is determined based on the writing on the sheet
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
Zabol University of Medical Sciences
Street address
Zabol, Jihad Square, Shahid Bagheri St., Zabol University of Medical Sciences Headquarters
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Approval date
2023-10-14, 1402/07/22
Ethics committee reference number
IR.ZBMU.REC.1402.079

Health conditions studied

1

Description of health condition studied
diabetes type 1
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Self care behaviors
Timepoint
Before the start of the intervention and 3 months later
Method of measurement
Toberth and Glasgow 2002 questionnaire measurement of HBA1C

Secondary outcomes

1

Description
Toberth and Glasgow 2002 questionnaire score
Timepoint
Before the intervention and one month later
Method of measurement
The average scores ranged from 0-70 and it was divided into three parts, and a general compliance score was obtained by summing the scores of each question.

2

Description
HBA1C
Timepoint
Before the intervention and 3 months later
Method of measurement
Metabolic tests (HbA1C) in children are all done in the same laboratory. The reliability of the laboratory instrument will be checked by checking the calibration of the device every time the device is used. Also, all the tests will be performed in the same environment and by a specific person and device.

Intervention groups

1

Description
Control group: Receive routine hospital training
Category
N/A

2

Description
Intervention group: Teaching self-care behaviors by the teachback method The first session provides explanations about diabetes and its causes and complications, ways to prevent complications • The second session provides necessary training on the type of diet, meal times and snacks • The third session teaches how to inject insulin and injection sites • The fourth session Training on how to check blood sugar and its hours and foot care. At the end of each session, to ensure that the client learns the said items, open questions are asked so that the topics can be repeated if necessary. This process continues until the client learns completely. In addition, at the beginning of each session, the training items of the previous session are asked in the form of open questions so that the training items of the previous session can be repeated if necessary. At the end of the session, the taught items are provided to the client in the form of an educational pamphlet.
Category
Behavior

3

Description
Intervention group: Teaching self-care behaviors by multimedia method • In the first session, explanations are given about diabetes and its causes and complications, ways to prevent complications• The second session of necessary training about the type of diet, the frequency of meals and snacks• The third training session on how to inject insulin and injection sites• The fourth training session on how to check blood sugar and its hours and take care of the feetIn the multimedia training group, the same content is used, but it is not presented face-to-face, instead, patients receive training videos through CDs, DVDs, and mobile device files. The content of these videos includes all the content that is taught face-to-face in the teaching group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Amirul Mominin Zabol Hospital
Full name of responsible person
Mehdi Khosravi
Street address
3rd km of Zabol Zahedan road, Amir al-Mominin Hospital, Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861979917
Phone
+98 54 3421 1303
Email
amirhospital@zbmu.ac.ir
Web page address
https://amir.zbmu.ac.ir/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
هادی میرزایی
Street address
Zabol, Jihad Square, Shahid Bagheri St., Central Headquarters of the University of Medical Sciences
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Fax
+98 54 3223 2023
Email
info@zbmu.ac.ir
Web page address
https://zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol University of Medical Sciences
Proportion provided by this source
1
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
Zabol University of Medical Sciences
Full name of responsible person
rahimeh zelhagh
Position
Special care senior student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 206, 4 Al-Ghadir St
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861733574
Phone
+98 915 033 0375
Email
rahime.zelhagh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Rahime Zelhagh
Position
Special care senior student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 206, 4 Al-Ghadir St
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861733574
Phone
+98 915 033 0375
Email
rahime.zelhagh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Rahimeh Zelhagh
Position
Special care senior student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 206, 4 Al-Ghadir St., Al-Ghadir
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861733574
Phone
+98 915 033 0375
Fax
Email
rahime.zelhagh@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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about illness and family conditions without identifying the client Only part of the data, such as information related to the main outcome, can be shared
When the data will become available and for how long
The access period starts one month after the publication of the article
To whom data/document is available
The opinion of researchers working in academic and scientific institutions
Under which criteria data/document could be used
All necessary analyzes are allowed for use in research related to children's diabetes
From where data/document is obtainable
gmai RAHIME ZELHAGH RAHIME.ZELHAGH@GMAI.COM
What processes are involved for a request to access data/document
Send a request to Gmail
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