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IRCT20210421051029N1 IRCT 2021-05-31 Esfahan University of Medical Sciences Effect of fathers on outcomes of hospitalized pediatrics with pneumonia Comparison of the effectiveness of an educational-supportive program for fathers and routine care program on outcomes of hospitalized pediatrics with pneumonia 2020-11-14 anticipated 40 Complete https://irct.ir/trial/55899 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: At first, one of the existing hospitals that treat children with pneumonia was selected by lottery. Children will be selected by available sampling method and finally each of the selected samples will be assigned to the control or intervention group with Random allocation software(RAS). In this way, the software determines the sample size and equal blocks and the software output will be used for random allocation. This method will continue until the number of samples reaches the desired number of samples, Blinding description: The patient participates in the study and is explained that he is in the study, but does not know which group he is in. N/A Pneumonia. Intervention 1: Intervention group:The educational-supportive program will include education and support for fathers with hospitalized children and the mother as the patient's primary caregiver.The education with the participation of parents in social networks will be held virtually for 4 consecutive days by sharing the educational content prepared for the fathers of the intervention group.Fathers will do the lessons seen by video communication twice a day for 15 to 30 minutes each time with a video call for their child. To receive information and promote knowledge, some information by the researcher about the child at toddler age (behaviors and physical symptoms) and the child's illness, the effect of hospital conditions on the child and mother, and teaching the role of the father in physical and emotional support and care of Child and spouse support in critical situations and understanding and knowing each other and working together to solve problems and not blame each other and about the child, as well as tips on how to interact with children through video calls. An educational package (including an education booklet and CD with instructions) will be given to fathers to use. Accordingly, to exchange information and transfer information between parents and the researcher, the father will be contacted through video calls and social networks within 4 days (twice a day) and with prior coordination with the researcher, before communicating with the child.They will be given the necessary training and support such as sleep hygiene and nutrition training and proper communication with mothers, and they will be asked to read the educational content shared in the virtual group before making a video communication.The fathers, with the cooperation of the researcher and under the supervision of the researcher, will participate in the video call and will implement the lessons learned.The educational content provided will include information on normal sleep patterns, children's sleep needs, signs and consequences of sleep disorders, sleep hygiene information, and anticipated tips on sleep and nutrition during hospitalization.The father will be asked to use relaxing behaviors and skills to prevent or reduce sleep problems.In addition, fathers will be asked to bring with them material as well as storybooks that include colorful pictures and fun characters, musical instruments, their child's latest artwork such as a painting, or whatever they want to show him. This not only allows the child to continue to communicate with the parents with interest but also increases comfort.It will also be planned in advance to share a snack or a meal with the child so that people have the same snack or meal on both sides of the screen and adults can pretend to enjoy it from the camera. They deliver the child. At the end of the video, people can play music and sing with each other or play age-appropriate games. Intervention 2: Control group: The control group will receive routine care. Questionnaires for this group will be completed at the time of admission and 7 days after admission. The educational content will be provided to the control group after the completion of the research. Yes - There is a plan to make this available What will be shared: Participant data file: If the results of the study indicate the need for this work, part of the data will be published after it becomes unidentifiable (demographic characteristics) and will be available to other researchers after being unidentifiable by sending an email. Study protocol: The study protocol will be displayed in articles for researchers and for citation by other researchers only citation of the article is sufficient. Informed consent form : It does not need to be published and only its title will be given in the articles and if necessary, the readers and the competent inspection authorities will be provided to them, but its raw form will be provided to the journals to publish the results of the study. Statistical analysis map: In the method section, the work will be provided and if used by other researchers, citing the article will suffice and no license will be required. Clinical study report: The results of the study will be published in the form of an article after the end of the study, and only citation to the article is sufficient to use the results. If needed more information will be available by email after being unidentified. When: After publishing the results in the article To whom: The data will be available to researchers Conditions: Can be used for secondary studies Where to obtain: The person in charge of research - sending email How to obtain: Will be sent after receiving the email Comments:
public Sajjad Khaksar
No. 54, Shahid Kharazi St., Modares Alley, Shahid Kharazi Street
Isfahan Iran (Islamic Republic of) 8344117875 +98 31 4572 4532 sajjadkh@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Faramarz Kalhor
No. 485,Side Alley 2., Marefat St., Janbazan Blvd
Isfahan Iran (Islamic Republic of) 6037697491 +98 31 3778 2166 faramarz@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) The age of the child is in the age range of 12 to 36 months The first day of hospitalization of a child with a diagnosis of pneumonia in the hospital Do not receive specific medicine for insomnia problems Have oral nutrition and do not receive complete intravenous feeding or gavage Parents' ability to use video call The child's family is willing and satisfied to participate in the study The mother does not have a mood disorder (not taking medication and not experiencing other stressful conditions other than discussing the child's hospitalization during the child's hospitalization) Father's presence in the family (not dead, etc.) 12 months 36 months Both Inability of the father to study educational program If communication device is not available (video call) Change the diagnosis of the child's disease J18.9 Pneumonia, unspecified organism Behavior Behavior Intervention group:The educational-supportive program will include education and support for fathers with hospitalized children and the mother as the patient's primary caregiver.The education with the participation of parents in social networks will be held virtually for 4 consecutive days by sharing the educational content prepared for the fathers of the intervention group.Fathers will do the lessons seen by video communication twice a day for 15 to 30 minutes each time with a video call for their child. To receive information and promote knowledge, some information by the researcher about the child at toddler age (behaviors and physical symptoms) and the child's illness, the effect of hospital conditions on the child and mother, and teaching the role of the father in physical and emotional support and care of Child and spouse support in critical situations and understanding and knowing each other and working together to solve problems and not blame each other and about the child, as well as tips on how to interact with children through video calls. An educational package (including an education booklet and CD with instructions) will be given to fathers to use. Accordingly, to exchange information and transfer information between parents and the researcher, the father will be contacted through video calls and social networks within 4 days (twice a day) and with prior coordination with the researcher, before communicating with the child.They will be given the necessary training and support such as sleep hygiene and nutrition training and proper communication with mothers, and they will be asked to read the educational content shared in the virtual group before making a video communication.The fathers, with the cooperation of the researcher and under the supervision of the researcher, will participate in the video call and will implement the lessons learned.The educational content provided will include information on normal sleep patterns, children's sleep needs, signs and consequences of sleep disorders, sleep hygiene information, and anticipated tips on sleep and nutrition during hospitalization.The father will be asked to use relaxing behaviors and skills to prevent or reduce sleep problems.In addition, fathers will be asked to bring with them material as well as storybooks that include colorful pictures and fun characters, musical instruments, their child's latest artwork such as a painting, or whatever they want to show him. This not only allows the child to continue to communicate with the parents with interest but also increases comfort.It will also be planned in advance to share a snack or a meal with the child so that people have the same snack or meal on both sides of the screen and adults can pretend to enjoy it from the camera. They deliver the child. At the end of the video, people can play music and sing with each other or play age-appropriate games. Control group: The control group will receive routine care. Questionnaires for this group will be completed at the time of admission and 7 days after admission. The educational content will be provided to the control group after the completion of the research. Sleep quality score. Timepoint: Measurement of sleep quality at the beginning of the study and one week after admission. Method of measurement: Brief Infant Sleep Questionnaire-R. Eating Behavior score. Timepoint: Measurement of Eating Behavior score at the beginning of the study and one week after admission. Method of measurement: Children’s Eating Behavior Questionnaire. Stress score. Timepoint: Measurement of stress score at the beginning of the study and one week after hospitalization. Method of measurement: stress response inventory (SRI) Scale. Esfahan University of Medical Sciences Approved 2021-01-02 Research Ethics Committee of Isfahan University of Medical Sciences No. 545,dead end 3 ,Modares Alley, Shahid Kharazi St., Moallem Blvd.,Gaz Borkhar,Isfahan isfahan Isfehan Iran (Islamic Republic of)