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IRCT20200223046586N2 IRCT 2020-05-30 Shahroud University of Medical Sciences web- based communication between nurse and family member The effect of the web- based communication between nurse and family member on perceived stress of family member of suspected and affected patients with COVID-19 2020-05-18 anticipated 74 Complete https://irct.ir/trial/47091 interventional Randomization: Randomized, Blinding: Single 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 https://www.sealedenvelope.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 4 is used to create random allocation sequences. According to the total number of samples required for the study, which is 74 patients (37 patients in the intervention group (A) and 37 patients in the control group (B)), 19 blocks with a volume of four includes two groups A and B will be randomly selected using the software, such as (ABAB) ، (BBAB)، (AABB)، (ABBA)، (BAAB ......( Then 74 pockets (37 pockets containing paper containing A and 37 pockets containing 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. After admission of each patient to the intensive care unit, will be given a pocket and assigned to Group A (intervention) or B (control group), and the sample process will be performed sequentially until the end of completion of sample size, Blinding description: Due to the nature of the study, it is not possible to blind participants and implement the intervention. However, demographic information and stress assessment questionnaires are performed at the beginning of the intervention by a trained nurse outside the research team. The data are given to the statistician for analysis. The data collector and analyst are not aware of how individuals are assigned to groups. 3 Covid -19. Intervention 1: Intervention group: Due to the absence of the family in the hospital, to access them, with the permission of the hospital manager, the telephone number of the family member of each patient will be asked and after calling the family and explaining the goals of the study and obtaining oral and written consent, A family with inclusion criteria will be included in the study. Then, the number of mobile phone improved enough to install Soroush or WhatsApp application will be asked from each family member so that this phone number can be contacted during the intervention period. Then, before the beginning of the intervention, a demographic information questionnaire and a perceived stress questionnaire ( PSS-14) will be completed by a family member (due to hospital conditions and the impossibility of the family attending the hospital, the online questionnaire will be sent to family members). Patient demographic information will be obtained from patient's medical record. Next, the web-based communication between the nurse and the family member will be done. Intervention content includes daily web contact by the researcher's family member. After communication, information is given about the status of vital signs, respiratory status, level of alertness, patient nutrition pattern, and no need for physical presence of the family in the hospital. Calls will be made within four days and include one call per day for 10-15 minutes. During the entire intervention period, four calls will be made during the patient's hospitalization in the intensive care unit. The contact time will be determined each day based on coordination with the family member. The questionnaire ( PSS-14) then will be completed by the family on the intervention day. For the family member, the questionnaire will be sent online. Then, after collecting the questionnaires, the information will be analyzed through SPSS software. Intervention 2: Control group: All routine medical treatment and care interventions, except web-based communication with the family, will be performed, and the PSS-14 questionnaire will be completed twice by the family member (at the beginning of the study and four days later). Yes - There is a plan to make this available What will be shared: Part of the demographic information of the patient and family member can be shared after identifying individuals. All information related to measuring the perceived stress in family member can be shared after identifying people. When: Access period starts from May 2020 To whom: Researchers and students of academic and scientific institutions Conditions: data for correlational studies Where to obtain: shariati.esmail@yahoo.com How to obtain: Clear explanation of the reason for the need to access the data and submit the data after two weeks Comments:
public Esmail Shariati
No 63. Alley 8. Foroughi Street
Shahroud Iran (Islamic Republic of) 3613733419 +98 23 3234 2000 shariati.esmail@yahoo.com Shahroud University of Medical Sciences scientific Hossein Ebrahimi
7th Square, Shahroud University of Medical Sciences, School of Nursing and Midwifery
Shahroud Iran (Islamic Republic of) 3614773947 +98 23 3239 3811 h_ebrahimi43@yahoo.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Satisfaction to participate in research Patients with COVID-19 whose disease has been diagnosed by lung CT scan and positive PCR and are undergoing standard treatment. Patients who are hospitalized in the Intensive Care Unit due to the severity of the disease. Having a family member (relative or causal) with web literacy and being able to communicate virtually and participate in a web-based communication program. The family member is not a member of the treatment team. no limit no limit Both Having hearing and speech problems The family member has psychological problems based on self-expression Patients who are in the control group and in any way provided with the possibility of web contact during the hospital stay Severe stress in the family over the past month except for a patient with Covid-19, such as death of other family members U07.2 COVID-19, virus not identified Other Other Intervention group: Due to the absence of the family in the hospital, to access them, with the permission of the hospital manager, the telephone number of the family member of each patient will be asked and after calling the family and explaining the goals of the study and obtaining oral and written consent, A family with inclusion criteria will be included in the study. Then, the number of mobile phone improved enough to install Soroush or WhatsApp application will be asked from each family member so that this phone number can be contacted during the intervention period. Then, before the beginning of the intervention, a demographic information questionnaire and a perceived stress questionnaire ( PSS-14) will be completed by a family member (due to hospital conditions and the impossibility of the family attending the hospital, the online questionnaire will be sent to family members). Patient demographic information will be obtained from patient's medical record. Next, the web-based communication between the nurse and the family member will be done. Intervention content includes daily web contact by the researcher's family member. After communication, information is given about the status of vital signs, respiratory status, level of alertness, patient nutrition pattern, and no need for physical presence of the family in the hospital. Calls will be made within four days and include one call per day for 10-15 minutes. During the entire intervention period, four calls will be made during the patient's hospitalization in the intensive care unit. The contact time will be determined each day based on coordination with the family member. The questionnaire ( PSS-14) then will be completed by the family on the intervention day. For the family member, the questionnaire will be sent online. Then, after collecting the questionnaires, the information will be analyzed through SPSS software. Control group: All routine medical treatment and care interventions, except web-based communication with the family, will be performed, and the PSS-14 questionnaire will be completed twice by the family member (at the beginning of the study and four days later). Perceived Stress. Timepoint: At the beginning of the study (before the start of the intervention) and 4 days later. Method of measurement: Perceived Stress Scale (PSS-14). A 14-item questionnaire in the 5-point Likert range between 0 and 4. The lowest score is zero and the highest score is 56, and getting a higher average score indicates more perceived stress. Shahroud University of Medical Sciences Approved 2020-05-09 Research Ethics Committee of Shahroud University of Medical Science Shahroud, Seventh Tir Square, Shahroud University of Medical Sciences and Health Services, Vice Chancellor for Research and Technology Shahroud Semnan Iran (Islamic Republic of)