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Study aim
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Effect of a supportive educational program on anxiety in children with kidney disease and burden of mothers’ care
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Design
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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
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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)
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Intervention groups
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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
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Main outcome variables
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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