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IRCT20210205050252N1 IRCT 2021-03-04 Tehran University of Medical Sciences Effect of family education at home The effect of family centered education in invasive home mechanical ventilation patients 2021-04-03 anticipated 60 Complete https://irct.ir/trial/54202 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sequence of random allocation and the list of blocks will be obtained by the statistical consultant with the help of software. The website http://www.sealedenvelipe.com is a useful site for generating random sequences for block type randomization. This site is designed in such a way that there is no limit on the number of groups for random allocation. Volume block method four is used to create random allocation sequences. Blocks consisting of two groups A and B randomly selected using the software such as (BAAB) ، (ABBA) ، (AABB) ، (BBAB). Then 60 pockets (30 pockets containing paper A and 30 pockets containing paper B) will be prepared based on sample size. According to a list of blocks, a trained person outside of the research team will be set the row of pockets. In the first stage, each patient will be randomly assigned to the A group (intervention) or B group (control). The sample process will be performed sequentially until the end of completion of sample size. Code of each patient will also be allocated to his family member. Patients are assigned to the study group in order of their entry into the study and randomly through randomized blocks. For example, according to the block (ABAB), each patient enters the intervention, control, intervention and control groups, respectively, after entering the study. This process continues until the last block is selected, Blinding description: The assignment of the groups will be done by someone out of the study and the investigator won't have any information about the assigned group. The group code of individuals will only be available to the lead researcher (supervisor) and the evaluators will not be aware of it. N/A Performance skills and family burden. Intervention 1: After getting informed consent, the main family caregiver will receive routine and emergency care training including suction, gavage, skin care, and cardiopulmonary resuscitation via face to face and on a replica before the patient is discharged home. The duration of the training will be five one-hour training sessions. The mentioned training booklet will also be provided to the family. Intervention 2: In the control group, the main family member will receive routine intensive care unit training including suction, gavage and skin care in a brief training session during discharge. 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 There is no more information
public Parvaneh Asgari
Nursing & Midwifery School, East Nosrat st., Tohid sq
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 p-asgari@razi.tums.ac.ir Tehran University of Medical Sciences scientific Parvaneh Asgari
Nursing & Midwifery School, East Nosrat st., Tohid sq.
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 p-asgari@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Desire for participating in the study The patient is under invasive home mechanical ventilation The primary caregiver is the person who has the most involvement in the treatment The caregiver should be able to read and write at least 18 years no limit Both In case of participation in a study that interferes with the current study N/A N/A After getting informed consent, the main family caregiver will receive routine and emergency care training including suction, gavage, skin care, and cardiopulmonary resuscitation via face to face and on a replica before the patient is discharged home. The duration of the training will be five one-hour training sessions. The mentioned training booklet will also be provided to the family. In the control group, the main family member will receive routine intensive care unit training including suction, gavage and skin care in a brief training session during discharge. Performance skills score in researcher-made checklists. Timepoint: Before and one week after education. Method of measurement: Researcher-made functional skills checklist. Family burden score. Timepoint: Three month after the intervention. Method of measurement: ZARIT burden questionnaire. Tehran University of Medical Sciences Approved 2019-06-25 Ethics committee of School of Nursing and Midwifery and School of Rehabilitation, Tehran University Nursing & Midwifery School, East Nosrat st., Tohid sq Tehran Tehran Iran (Islamic Republic of)