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Investigating the effect of self-care training on self-efficacy and quality of life of children with nephrotic syndrome and their parents

Protocol summary

Study aim
Self-care training can be effective in reducing the length of hospitalization of patients and, as a result, reducing the cost of treatment, reducing mortality, and improving the outcome of the disease. Therefore, the present study aims to determine the effect of self-care training on the self-efficacy and quality of life of children with nephrotic syndrome and their parents.
Design
This randomized clinical trial with a control group, pre-test-post-test design, without blinding, was conducted on 60 children with nephrotic syndrome along with their parents who referred to Mofid Children's Hospital in Tehran. In order to randomize, the table of random numbers was used to determine the number of research samples that should enter the intervention group.
Settings and conduct
This study was conducted on 60 children with nephrotic syndrome along with their parents who referred to Mofid Children's Hospital in Tehran. Blinding methods were not used. The table of random numbers was used for simple randomization.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include the age of the child between 7 and 18 years, having been treated for at least one year, parents having the ability to read and write. Also, children and parents should not have a history of mental disorders, the child should not have a history of kidney transplant. Exclusion criteria included absence of parents in educational sessions and unwillingness to participate in the study.
Intervention groups
The intervention group in this study received face-to-face training sessions. The control group received routine measures and no new intervention.
Main outcome variables
Parents' self-efficacy, parents' quality of life, children's quality of life, children's self-efficacy.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230816059164N2
Registration date: 2024-01-09, 1402/10/19
Registration timing: retrospective

Last update: 2024-01-09, 1402/10/19
Update count: 0
Registration date
2024-01-09, 1402/10/19
Registrant information
Name
Mohammad Mehdi Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 939 811 2685
Email address
mmehdirajabi1379@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2020-11-21, 1399/09/01
Trial completion date
2020-12-21, 1399/10/01
Scientific title
Investigating the effect of self-care training on self-efficacy and quality of life of children with nephrotic syndrome and their parents
Public title
Investigating the effect of self-care training on self-efficacy and quality of life of children with nephrotic syndrome and their parents
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the child between 7 to 18 years The child has received treatment for at least one year Parent's ability to read and write The diagnosis of nephrotic syndrome of the child has been confirmed by a specialist doctor
Exclusion criteria:
Having a history of mental or physical disorders in parents or children The child has a history of kidney transplant
Age
From 7 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
A person, who was unaware of the study, determined 36 numbers from 1 to 72 using a table of random numbers. These numbers were the numbers of samples that should be included in the intervention group. These numbers were provided to the research team. Thus, after sampling according to the available method, according to the number of samples, they entered the control or intervention group.
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
School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical Sciences (Ethics Com
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nusrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-12-23, 1398/10/02
Ethics committee reference number
IR.TUMS.FNM.REC.1398.159

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
Quality of life of the child
Timepoint
Before the start of the intervention, 4 weeks after the start of the intervention
Method of measurement
Pediatric's Quality of Life Questionnaire (PedsQL)

2

Description
Quality of life of parents
Timepoint
Before the start of the intervention, 4 weeks after the start of the intervention
Method of measurement
World Health Organization Quality of Life Summary Questionnaire (WHOQOL-BREF)

3

Description
Self-efficacy of parents
Timepoint
Before the start of the intervention, 4 weeks after the start of the intervention
Method of measurement
General Self-Efficacy Questionnaire (GSES)

4

Description
Children's self-efficacy
Timepoint
Before the start of the intervention, 4 weeks after the start of the intervention
Method of measurement
Children's Self-Efficacy Questionnaire (SEQ-C)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention consisted of "self-care training", derived from Orem's self-care theory, which was carried out in two 60 minute face-to-face training sessions and the presentation of a training booklet containing the topics presented in the training sessions with the presence of children with nephrotic syndrome and their parents. The interval between the sessions was two weeks, the researcher had telephone and face-to-face contact with the samples of the intervention group during this time period. Questionnaires of self-efficacy and quality of life were completed by children and parents in the intervention group, before the beginning of the training sessions and 4 weeks later.
Category
N/A

2

Description
Control group: The control group received routine training by the medical center personnel after completing the pre-test at the same time as the test group. In this group, routine hospital follow-ups were done. Self-efficacy and quality of life questionnaires were completed by children and parents in the control group at the same time as the intervention group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mofid Children's Hospital
Full name of responsible person
Shamsullah Nouripour
Street address
Mirdamad St, Above Hosseinieh Irshad, Dr. Ali Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
15514- 15468
Phone
+98 21 2222 7021
Email
info-mch@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotohi
Street address
6th floor of Research and Technology Vice-Chancellor, Central Organization of the University, corner of Quds St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6105 4567
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Rajabi
Position
Master's student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nusrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4424
Email
mmehdirajabi1379@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Rajabi
Position
Master's student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nusrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4424
Email
mmehdirajabi1379@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Rajabi
Position
Master's student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nusrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4424
Email
mmehdirajabi1379@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
Undecided - It is not yet known if there will be 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
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