Protocol summary

Study aim
Effect of a supportive educational program on anxiety in children with kidney disease and burden of mothers’ care
Design
The research is a clinical trial study in two groups and three stages to evaluate the effect of independent variable of supportive training program on two dependent variables including the grade of children's anxiety as well as the score of the burden of their mothers’ care. Sampling will be done with continuous easy method from all children referred to the Alzahra and Emam Hosein hospital in Isfahan. So 120 children with their mothers, which have inclusion criteria, would randomly selected and assigned to two groups: test and control groups. Accidental assignment of samples in two groups of test or control will be using a numbers packet. The test group will attend in supportive educational program that will be held simultaneously for mothers and children as 5 daily 45-50 minutes sessions. The control group will participate in one question and answer session which held by researcher. Data collection in this research will be done using a 3-part questionnaire including demographic profile of the child and mother, visual anxiety measurement tool for children and the Zarit scale questionnaire to assess caregiver burden for mothers. Before beginning the study, the Holmes and Rahe scale was also completed by mothers for individuals’ inclusion into the research. Both groups will answer questionnaires before and immediately after the intervention and also one month after the intervention. Data of this research will be collected before and immediately after the intervention as well as one month later
Settings and conduct
This study will be done on children referred to Al-Zahra and Emam Hossein Hospital in Isfahan. So 120 children with their mothers, which have inclusion criteria, would randomly selected and assigned to two groups: test and control groups. The test group will attend in supportive educational program that will be held simultaneously for mothers and children as 5 daily 45-50 minutes sessions. The control group will participate in one question and answer session which held by researcher. Data collection in this research will be done using a 3-part questionnaire including demographic profile of the child and mother, visual anxiety measurement tool for children and the Zarit scale questionnaire to assess caregiver burden for mothers. Before beginning the study, the Holmes and Rahe scale was also completed by mothers for individuals’ inclusion into the research. Both groups will answer questionnaires before and immediately after the intervention and also one month after the intervention. Data of this research will be collected before and immediately after the intervention as well as one month later
Participants/Inclusion and exclusion criteria
Inclusion criteriafor children: Suffering from kidney disease (kidney failure, Glomerulonephritis, Nephrotic syndrome, Urinary tract infection, ESRD and other diseases of renal system);It was passed at least three months from diagnosis;Being accompanied by mother during the hospitalization;Living in Isfahan;Having mental health;Not being diagnosed with known psychiatric diseases and necessary consciousness to the extent that does not hinder the research( referring to medical documents and records of the disease);Not using medicine to reduce anxiety and pain except for kidney disease (referring to the doctors' recorded orders); The lack of experience of critical events over the past year including: death of a parent, sister or brother's death, parental divorce and severe accident based on the questions which were asked from the patients’ mothers. Inclusion criteriafor the mother: Considered as having at least elementary education;Not being as medical staff (Physician, nurse and ...); Not being diagnosed with known psychiatric diseases and lack of taking psychedelic drugs by motherbased on the questions which were asked from the mothers;Lack of experience of a critical event over the past year with using Holmes-Rahe scale. Exclusion criteria: Child and their family’s unwillingness to continue the research at each stage;Deterioration of child’s health condition in the course of the disease during the study and then referring to the physician;Prescribing and taking anxiolytic and tranquilizing drugs during hospitalization of child and according to the doctor's order and according to medical records for some reasons except for kidney disease;Discharge of the child before the end of the curriculum of supportive education;Child affliction due to infectious diseases;Lack ofchild and her or his mother’s regular attendance at meetings (absence more than two sessions)
Intervention groups
The test group will attend in supportive educational program that will be held simultaneously for mothers and children as 5 daily 45-50 minutes sessions. The control group will participate in one question and answer session which held by researcher. Data of this research will be collected before and immediately after the intervention as well as one month later
Main outcome variables
The proposed non-pharmacological application to children's treatment centers based on a supportive educational program is based on findings to improve the anxiety of children with chronic renal diseases and reduce the maternal care burden

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171028037045N1
Registration date: 2018-01-21, 1396/11/01
Registration timing: retrospective

Last update: 2018-01-21, 1396/11/01
Update count: 0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
niloofar bahrami
Name of organization / entity
isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3680 5498
Email address
n.bahrami@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Isfahan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a supportive educational program on anxiety in children with kidney disease and burden of mothers’ care
Public title
Effect of a supportive educational program on anxiety in children with kidney disease and burden of mothers’ care
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria for children:Suffering from kidney disease (kidney failure, Glomerulonephritis, Nephrotic syndrome, Urinary tract infection, ESRD and other diseases of renal system); It was passed at least three months from diagnosis; Being accompanied by mother during the hospitalization; Living in Isfahan; Having mental health; Not being diagnosed with known psychiatric diseases and necessary consciousness to the extent that does not hinder the research( referring to medical documents and records of the disease); Not using medicine to reduce anxiety and pain except for kidney disease (referring to the doctors' recorded orders); The lack of experience of critical events over the past year including: death of a parent, sister or brother's death, parental divorce and severe accident based on the questions which were asked from the patients’ mothers. Inclusion criteria for the mother:Considered as having at least elementary education; Not being as medical staff (Physician, nurse and ...); Not being diagnosed with known psychiatric diseases and lack of taking psychedelic drugs by mother based on the questions which were asked from the mothers; Lack of experience of a critical event over the past year with using Holmes-Rahe scale.
Exclusion criteria:
Exclusion criteria:Child and their family’s unwillingness to continue the research at each stage; Deterioration of child’s health condition in the course of the disease during the study and then referring to the physician; Prescribing and taking anxiolytic and tranquilizing drugs during hospitalization of child and according to the doctor's order and according to medical records for some reasons except for kidney disease; Discharge of the child before the end of the curriculum of supportive education; Child affliction due to infectious diseases; Lack of child and her or his mother’s regular attendance at meetings (absence more than two sessions)
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Accidental assignment of samples in two groups of test or control will be using a packet, in which there are pairs and odd numbers written on cardboard cards. So, for example, the researcher first specifies randomly that patients with a coupled number will be in the test group (intervention) and those whose have odd number will be in the control group. When the samples are entered into the study with the entry conditions in an easy way, the card for which he leaves the envelope, depending on whether he has a pair number or odd, he is in one of the two test group (intervention) and or control group, and random sampling and assignment will continue to complete the required number of samples.
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
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib Ave, Isfahan University of Medical Sciences, Faculty of nursing and midwifery, Isfahan City.
City
Isfahan
Province
Isfehan
Postal code
8144117625
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.MUI.REC.1396.3.445

Health conditions studied

1

Description of health condition studied
chronic kidney diseases
ICD-10 code
N17-N19
ICD-10 code description
P96.0

Primary outcomes

1

Description
children anxiety
Timepoint
before the intervention, immidiately after the intervention, one month after the intervention
Method of measurement
visual anxiety measurement tool

2

Description
caregiver burden for mothers
Timepoint
before the intervention, immidiately after the intervention, one month after the intervention
Method of measurement
Zarit scale questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The test group will attend in supportive educational program that will be held simultaneously for mothers and children as 5 daily 45-50 minutes sessions. The control group will participate in one question and answer session which held by researcher
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Mahdi Nasr Esfahani
Street address
Al-Zahra Medical Education Center- Safavi Boulevard- Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1250
Email
ari@mui.ac.ir
Web page address
http://www.ari.mui.ac.ir

2

Recruitment center
Name of recruitment center
Emam Hossein hospital
Full name of responsible person
Dr. Mehrdad Meemarzadeh
Street address
Emam Hossein Children's Therapeutic Hospital, Km 10 of Imam Khomeini Ave (RA) , Isfahan.
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3386 6266
Email
emamhossein_hospital@mui.ac.ir
Web page address
http://www.ehuch.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research center of Isfahan University of Medical Sciences
Full name of responsible person
Mrs Maryam Maroufi
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
n.bahrami@nm.mui.ac.ir
Web page address
http://www.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center of Isfahan 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
Niloofar Bahrami
Position
MSc
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3680 5498
Fax
Email
n.bahrami@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mrs Maryam Maroufi
Position
MSc
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7607
Fax
Email
marofi@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Niloofar Bahrami
Position
MSc
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3680 5498
Email
n.bahrami@nm.mui.ac.ir

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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