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IRCT20130616013690N9 IRCT 2021-04-12 Shiraz University of Medical Sciences The effect of virtual child disease management program on parents of children with coagulation factor deficiencies The effect of virtual child disease management program on caregiver burden and social adjustment in parents of children with coagulation factor deficiencies 2021-04-19 anticipated 60 Complete https://irct.ir/trial/51647 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Firstly, 60 parents who their child have a record in the Hemophilia Center will be selected using a table of random numbers. Then, a random allocation software will be used to create 15 blocks with a block size of four. in order to create a list of block randomization, refer to following website is done: https://www.sealedenvelope.com/simple-randomiser/v1/lists. Then, based on this generated list (BABA, ABBA, BAAB, BABA, AABB, ...), the subjects will be allocated into the intervention (B) or control (A) groups, Blinding description: In order to perform blinding, assistant researcher who collects data before and after the intervention, as well as statistician who analyzes the data, are blinded to the groups and the assignment of individuals in the groups. N/A Condition 1: Hemophilia A. Condition 2: Hemophilia B. Condition 3: Von Willebrand's disease. Intervention 1: Intervention group: In this group, child disease management intervention focuses on all human dimensions, including physical, psychological, social and spiritual dimensions. The content will be provided to the participants through pamphlets, PowerPoint and videos (MP4) prepared with Camtasia Studio software by WhatsApp. Physical interventions focus on how hemophilia disease and its limitations in pediatric, bleeding, pain, arthropathy, and physical activities are managed. In the psychological dimension, how to coping with child’ illness, how you deal with child hemophilia, your perception to child disease, positive thinking, laughte therapy and nature therapy are done. Social interventions include disease management in society, such as how to participate in social and job activities, and how to interact between parents, child with others, and how to child to school. Spiritual interventions include hope, prayer, and communication with God. The duration of the intervention is 8 weeks. During these 8 weeks, the prepared content is uploaded on the social network ( WhatsApp) on a daily basis. Confirmation of receipt of the program is then obtained from each participant and they are asked to watch, hear or read the presented material the next day and if they have any questions, ask their questions. The program continues until the end of the eighth week. Intervention 2: Control group: This group would receive the routine care by hemophilia center and would not receive any of the interventions of the intervention group. The parents of this child come to the Hemophilia center to receive a factor or to treat the bleeding. They may be briefed at the center on how to use the factor when the child has bleeding. Yes - There is a plan to make this available What will be shared: Primary outcomes would be shared. When: Starting 6 months after publication article To whom: People and researchers working in academic institutions Conditions: Data are provided for information only. Where to obtain: Data is available via email rambodma@yahoo.com. How to obtain: Data is available via email rambodma@yahoo.com. Comments:
public Masoume Rambod
Shiraz. Zand Street, Namazi Square. School of Nursing Midwifery, Shiraz
Shiraz Iran (Islamic Republic of) 71936–13119 +98 71 3677 4254 rambodma@yahoo.com Shiraz University of Medical Sciences scientific Masoume Rambod
Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4258 rambodma@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Parents with a child in the age range of 1-11 years Parents of a child with coagulation factor deficiencies Parents' oriented to time, person and place Parents' living with this child in the same house Parents' access to the Internet and social networks 1 year 11 years Both Parental participation in a similar disease management program over the past 3 months Parents suffering from known mental diseases such as depression, anxiety, and psychosis The child suffering from congenital, chromosomal, neuro-muscular and systemic diseases D66 D67 D68.0 Hereditary factor VIII deficiency Hereditary factor IX deficiency Von Willebrand's disease Lifestyle N/A Intervention group: In this group, child disease management intervention focuses on all human dimensions, including physical, psychological, social and spiritual dimensions. The content will be provided to the participants through pamphlets, PowerPoint and videos (MP4) prepared with Camtasia Studio software by WhatsApp. Physical interventions focus on how hemophilia disease and its limitations in pediatric, bleeding, pain, arthropathy, and physical activities are managed. In the psychological dimension, how to coping with child’ illness, how you deal with child hemophilia, your perception to child disease, positive thinking, laughte therapy and nature therapy are done. Social interventions include disease management in society, such as how to participate in social and job activities, and how to interact between parents, child with others, and how to child to school. Spiritual interventions include hope, prayer, and communication with God. The duration of the intervention is 8 weeks. During these 8 weeks, the prepared content is uploaded on the social network ( WhatsApp) on a daily basis. Confirmation of receipt of the program is then obtained from each participant and they are asked to watch, hear or read the presented material the next day and if they have any questions, ask their questions. The program continues until the end of the eighth week. Control group: This group would receive the routine care by hemophilia center and would not receive any of the interventions of the intervention group. The parents of this child come to the Hemophilia center to receive a factor or to treat the bleeding. They may be briefed at the center on how to use the factor when the child has bleeding. Caregiver burden. Timepoint: Before and 8 weeks after the intervention. Method of measurement: The HEMOphilia associated CAregiver Burden scale (HEMOCAB). Parental Social adjustment. Timepoint: Before and 8 weeks after the intervention. Method of measurement: Bell’s Social Adjustment Inventory. Shiraz University of Medical Sciences Approved 2020-11-16 Ethic Committee of Shiraz University of Medical Sciences Vice chancellor for research affairs, seven floor, Shiraz University of Medical Science, beside Helal Ahmar, Zand Ave, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)