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IRCT20200223046586N4 IRCT 2021-05-24 Shahroud University of Medical Sciences The Video communication between patient and family member on hospital anxiety and depression and perceived stress of family member The effect of the Video communication between patient and family member on hospital anxiety and depression of of affected patients with COVID-19 and perceived stress of family member 2021-06-04 anticipated 80 Complete https://irct.ir/trial/56369 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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 80 patients (40 patients in the intervention group (A) and 40 patients in the control group (B)), 20 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 80 pockets (40 pockets containing paper containing A and 40 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 and hospital anxiety and depression 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. N/A Covid-19 Disease. 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 starting the intervention, the Demographic Information Questionnaire and the Perceived Stress Questionnaire (PSS-14) are completed by a family member due to the hospital conditions and the impossibility of the family attending the hospital, an online questionnaire is sent to family members. The Hospital Anxiety and Depression Scale is completed by patients. Patient demographic information will be obtained from patient's medical record. Next, the video communication between the patient and the family member will be done. Calls will be made within three days and include one call per day for 5-10 minutes. During the entire intervention period, three 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 questionnaires are then completed again by the family and the patient on the day of the intervention. After collecting the questionnaires, the information will be analyzed through SPSS software. Intervention 2: Control group: All routine treatment and care interventions except video communication between patient and family member are performed for the control group. In the control group, if a family member contacts the intensive care unit, their questions will be answered and short-term telephone conversations will be provided if the physical condition is favorable. Questionnaires will be used twice at the beginning of the study and 24 hours after the intervention to be completed. Yes - There is a plan to make this available What will be shared: Part of the patient and family member demographic information can be shared after the person is not identified. All information about the patient's anxiety and stress in the family member can be shared after the person is not identified. When: From the end of August 2021 To whom: Researchers / students of health sciences Conditions: A clear explanation of the reason for the need to access the data and provide the data after two weeks Where to obtain: See the email address below shariati.esmail@yahoo.com How to obtain: After providing the reason for the need to access the data and send it to the following email, the data will be provided. shariati.esmail@yahoo.com Comments:
public Esmail Shariati
Imam Hossein Hospital Shahroud Semnan Iran
shahroud Iran (Islamic Republic of) 3616951835 +98 23 3234 2000 shariati.esmail@yahoo.com Shahroud University of Medical Sciences scientific Shahroud University of Medical Sciences
7th Square, Shahroud University of Medical Sciences, School of Nursing and Midwifery
shahrood Iran (Islamic Republic of) 3614773947 +98 23 3239 3811 h_ebrahimi43@yahoo.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Suspected and definitive patients with COVID-19 by a specialist through chest CT scan and positive PCR . Patients who are hospitalized in the intensive care unit due to the severity of the disease and are not intubated. Patients who have been hospitalized in the intensive care unit for a maximum of 24 hours. A family member who has a relative or causal relationship with the patient . Have web literacy and be able to communicate via video. 18 years 65 years Both Be a family member of the treatment team. Have hearing and speech problems. The family member has psychological problems based on self-declaration. Occurrence of severe stress in the family during the past month other than the patient contracting Covid-19, such as death of family members U07.2 COVID-19, virus not identified Behavior Behavior 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 starting the intervention, the Demographic Information Questionnaire and the Perceived Stress Questionnaire (PSS-14) are completed by a family member due to the hospital conditions and the impossibility of the family attending the hospital, an online questionnaire is sent to family members. The Hospital Anxiety and Depression Scale is completed by patients. Patient demographic information will be obtained from patient's medical record. Next, the video communication between the patient and the family member will be done. Calls will be made within three days and include one call per day for 5-10 minutes. During the entire intervention period, three 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 questionnaires are then completed again by the family and the patient on the day of the intervention. After collecting the questionnaires, the information will be analyzed through SPSS software. Control group: All routine treatment and care interventions except video communication between patient and family member are performed for the control group. In the control group, if a family member contacts the intensive care unit, their questions will be answered and short-term telephone conversations will be provided if the physical condition is favorable. Questionnaires will be used twice at the beginning of the study and 24 hours after the intervention to be completed. Hospital Anxiety and Depression. Timepoint: Before the intervention and 24 hours after the intervention. Method of measurement: Hospital Anxiety and Depression Scale (HADS) containing 14 questions on a 5-point Likert scale. Perceived Stress. Timepoint: Before the intervention and 24 hours after the intervention. Method of measurement: Perceived Stress Scale (PSS) containing 14 questions on a 5-point Likert scale. Shahroud University of Medical Sciences Approved 2021-05-08 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)