Protocol summary

Study aim
The purpose of this study is to improve the self-concept of children with nephrotic syndrome through conceptual mapping and feedback-based educational methods, which will lead to an increase in the child's adaptation to her/his illness and quality of life.
Design
A clinical trial with a control group, with parallel groups, a blind strain, randomized, with a sample size of 70 patients, a simple method was used for randomization.
Settings and conduct
The purpose of this research is to provide educational content to deal with problems in order to improve self-concept, which in turn improves health. The location of the study is Akbar Children's Nephrology Clinic and Dr. Sheikh Mashhad, and the method of conducting the study is four 45-minute individual sessions. These training sessions are in the form of lectures (feedback) depending on the child's placement in the intervention or control groups. axis) or written and visual (conceptual maps). This research is one-sided blind and the statistical analyst will analyze the data without knowing the study groups.
Participants/Inclusion and exclusion criteria
Children enter the study according to the criteria of entry and exit
Intervention groups
Intervention groups: the first group: self-care training using concept maps, the second group: self-care training using feedback-based method, both intervention groups during 4 days and 4 45-minute individual sessions, the necessary training in the field of self-care and self-concept improvement according to the type The group will receive (concept map, feedback-based), so that at the end, the effectiveness of each of the educational methods on improving self-concept will be measured.
Main outcome variables
On the fourth day of VSM, after the training, the self-concept questionnaire of Pirzaharis will be completed, checked and recorded by the researcher by asking the children under study.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221219056869N1
Registration date: 2023-04-08, 1402/01/19
Registration timing: registered_while_recruiting

Last update: 2023-04-08, 1402/01/19
Update count: 0
Registration date
2023-04-08, 1402/01/19
Registrant information
Name
Nazanin Kazar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 8395
Email address
kazarn971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-11, 1401/12/20
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of self-care training using conceptual mapping and feedback-based methods on the self-concept of children with nephrotic syndrome
Public title
Comparison of the effect of self-care training using conceptual mapping and feedback-based methods on the self-concept of children with nephrotic syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Informing the child about her/his illness Age between 7 and 12 years One year has passed since the diagnosis of nephrotic syndrome for the child The child should be able to read and write at a low level
Exclusion criteria:
The child has another physical disease in addition to nephrotic syndrome The child or the parents have a type of mental illness
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, randomization will be done in a simple way. Patients will be selected by convenience sampling and based on inclusion criteria, and then assigned to the intervention or control group by coin toss.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, the statistical analyst will analyze the data without knowing the study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of scahool of Nursing and Midwifery- Mashhad Univercity of Medical Scienc
Street address
No. 12, 5 Shahrestani St, Shahrestani Blvd., Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.100

Health conditions studied

1

Description of health condition studied
Nephrotic syndrome
ICD-10 code
N04
ICD-10 code description
Nephrotic syndrome

Primary outcomes

1

Description
Self-concept score in Piers-Harris questionnaire
Timepoint
At the beginning of the study (before the start of the intervention), 4 days after the start of the intervention and 30 days after the end of the study.
Method of measurement
Piers Harris self-concept questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Children suffering from nephrotic syndrome who receive training in four 45-minute individual sessions daily in the field of (nutrition, self-concept improvement, happy living, routine care of the disease) by the method of concept maps (drawn on paper appropriate to the age of the children ) and at the end of the sessions in Venice, 30 days after the end of the study, self-concept variable will be measured by Pirzaharis self-concept questionnaire.
Category
Behavior

2

Description
The second intervention group: children with nephrotic syndrome who will receive training in four 45-minute individual sessions daily in the field of (nutrition, self-concept improvement, happy living and routine care of the disease) in a feedback-oriented method (speech and question and answer). At the end of the sessions in Venice, 30 days after the end of the study, self-concept variable is measured by Pirzaharis self-concept questionnaire.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Sheikh Hospital
Full name of responsible person
Hamid Reza behnam voshani
Street address
No. 12, 5 Shahrestani St, Shahrestani Blvd., Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Kazarn971@mums.ac.ir

2

Recruitment center
Name of recruitment center
Akbar Hospital
Full name of responsible person
Hamid Reza behnam voshani
Street address
No. 12, 5 Shahrestani St, Shahrestani Blvd., Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Kazarn971@mums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayor Moberhan
Street address
No. 12, 5 Shahrestani St, Shahrestani Blvd., Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
Ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Nazanin Kazar
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 12, 5 Shahrestani St, Shahrestani Blvd., Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 5725 8395
Email
Kazarn971@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nazanin Kazar
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 12, 5 Shahrestani St, Shahrestani Blvd., Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Kazarn971@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nazanin Kazar
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 12, 5 Shahrestani St, Shahrestani Blvd., Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 5725 8395
Email
Kazarn971@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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