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IRCT20181013041324N1 IRCT 2018-12-05 Iran University of Medical Sciences Effect of training on depression, anxiety and stress in mothers with phenylketonuria child Effect of training on depression, anxiety and stress in mothers with phenylketonuria child 2018-10-16 anticipated 74 Complete https://irct.ir/trial/34489 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Among the mothers with phenylketonuria child referring to the phenylketonuria clinic of Ahvaz's children's hospital in Abouzar, the mothers who are willing to participate in the research and who meet the criteria for entry, sampling was done in an accessible manner and then by random allocation of units The research is done in two groups: intervention and control. the sample size is 74 people. They were selected by available sampling method and randomly divided into two groups: intervention and control (37 cases, 37 controls); we have a list of patients' names and Calling the mothers with the affected patient. To prevent contamination between the two intervention and control groups, allocation of research units to the two groups will be in the form of a timetable and through a lottery (throwing coins). In order to prevent information exchange, first the control group will complete the demo questionnaire and the DASS 21 questionnaire immediately and one month later, Blinding description: In this study, we have two groups of intervention and control that none of the participating groups will know which intervention is, and which is the control group, and is in fact a blind one. N/A Effect of training on depression, anxiety and stress in children with phenylketonuria. Intervention 1: Intervention group: For the intervention group, a 5-session class on Wednesday, every week, and every 1 hour and ten minutes for each session, the intervention group will first have a lecture and then a Q & A session, and at the end of each session, mothers will raise their concerns about the affected child. At the end of the sessions, an educational package containing an overview of the training given will be provided to the intervention sample. Immediately after training and 4 weeks after the completion of the training, the mothers of the intervention group will be interviewed and their anxiety will be measured by a questionnaire for the second and third times. The content of these training sessions will be in 5 sections. Intervention 2: Control group: There will be no training in the control group. At the end of the study, in order to observe the ethics in the research, the content of the training will be provided to the control group and, if desired, individual training will be given. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Leila Neisani Samani
West Hamو Between Sheikh Fazlollah Nouri and Shahid Chamran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 4465 2302 Neisani89@gmail.com Iran University of Medical Sciences scientific Leila Neisani Samani
West Hamو Between Sheikh Fazlollah Nouri and Shahid Chamran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 4465 2302 Neisani89@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) The mother has the main role of keeping the child affected. The person caring for the patient should not have a history of phenylketonuria. Mother is not a member of the health professional team. The mother has not participated in a class or any kind of special education for the disabled child. Mother has no tense experiences in the last 3 months The mother has no known mental illness and does not use sedative medications Parents do not have addiction. Parents are not exposed to the process of separation The mother of the child is married and lives with her husband The mother has no chronic long-term illness. The age of the affected child is 9 years or less. The child has a classical phenylketonuria disease 3 to 6 months from the diagnosis of the disease. no limit no limit Female Mothers who are not willing to enter the study. Mothers who are being treated with anti-anxiety drugs. Mothers who have anxiety disorders. Mothers who are being treated with anti-depressant drugs. N/A N/A Intervention group: For the intervention group, a 5-session class on Wednesday, every week, and every 1 hour and ten minutes for each session, the intervention group will first have a lecture and then a Q & A session, and at the end of each session, mothers will raise their concerns about the affected child. At the end of the sessions, an educational package containing an overview of the training given will be provided to the intervention sample. Immediately after training and 4 weeks after the completion of the training, the mothers of the intervention group will be interviewed and their anxiety will be measured by a questionnaire for the second and third times. The content of these training sessions will be in 5 sections Control group: There will be no training in the control group. At the end of the study, in order to observe the ethics in the research, the content of the training will be provided to the control group and, if desired, individual training will be given. Anxiety and Stress Scale in questionnaire Depression Anxiety Stress Scale 21. Timepoint: Measure the stress score, depression and anxiety before the intervention, immediately after training and four weeks after completion of the training. Method of measurement: Questionnaire Depression Anxiety Stress Scale 21. Iran University of Medical Sciences Approved 2018-08-25 Ethics committee of Iran University of Medical Sciences Shahid Hemmat West Highway, between intersection of Sheikh Fazlollah Noori and Shahid Chamran Tehran Tehran Iran (Islamic Republic of)