The effect of multimedia-based peer support groups on anxiety in patients with COVID-19: a parallel randomized clinical trial

Determining the effectiveness of peer-based communication on anxiety in patients with COVID-19

A clinical trial with a control group, with parallel groups, single blind ,on 100 patients

The study site is the inpatient wards of patients with Covid-19 in Imam Hossein Hospital in Shahroud. The content of the intervention includes a short educational-supportive video for 10 to 15 minutes, which includes interviews with two patients with COVID-19 who have been discharged from the hospital after recovery. One patient has experience of hospitalization in the ward and next patient has experience of hospitalization in the Intensive Care Unit following COVID-19. During the visual communication with these patients, they are asked to talk about the hospitalization experience, the conditions they had during the hospitalization, the actions they took care of during the hospitalization, the conditions they currently have.

Inclusion criteria - Patients with COVID-19 diagnosed by an infectious specialist by chest CT scan or positive PCR - The patient is in the age range of 18 to 75 years. - Patients who are able to communicate. Exclusion criteria: - Have hearing and speech problems. - The patient has psychological problems based on self-declaration. - Existence of cognitive disorders in elderly patients that affect the possibility of communication.

.For the intervention group, peer-based communication will be implemented. The content of the intervention includes the presentation of a short educational-supportive video and 24 hours after, the anxiety test questionnaire is completed for the second time in both groups. Patients in the control group receive all routine care programs except peer-to-peer communication.

Patients' anxiety

Because patients are gradually admitted to the study and to block the sample size in the two groups, the block method of volume 4 is used. For this purpose, 6 quadruple blocks will be created as follows (AABB, ABAB, ABBA, BBAA, BABA, BAAB). Where A is for the experimental group 1 and B is for the control group. The random assignment will be done in such a way that a random number from 0 to 9 will be created in Excel first. Depending on which block the random number belongs to, the sequence of that block will be used to assign patients to the control and intervention groups. For example, if the random number generated is 6, the first person will be assigned to group B, the second person to group A, the third person to group A, and the fourth person to group B. To reach the calculated sample size, the random number creation will be repeated 25 times. Because in each repetition, the assignment of four patients is determined. It should be noted that if the random number generated is 7, 8, 9 and 0, it will be ignored. In order to prevent contamination of the samples in the control group and blinding during the screening of the film, it was decided to randomly select two separate sections related to the hospitalization of patients with Covid -19, one section for patients in the experimental group and one section for patients in the control group. To do this, 4 envelopes containing (ward 1: experimental) (ward 1: control) (ward2: experimental) (ward 2 control) are prepared and one of these 4 envelopes is randomly selected to randomly determine which of ward is related to the experimental group and which is related to the control group. After each patient is randomly entered into the study and selected based on random blocks, each person will be selected from the ward based on the assigned code. For example, based on ABBA block (experimental group A) and (control group B) for the first patient: the experimental group of ward 1, 2 patients after the control group and ward 2 and again the fourth patient of the experimental group of ward 1 will be selected So that the patients of the two groups are not in contact. The random allocation sequence and the list of quadruple blocks are obtained by the statistics consultant with the help of Excel. Patients who meet the inclusion criteria are registered by the first administrator. Then, based on the prepared blocks, after entering the study, each patient is assigned to the desired group in the order of their entry.

Due to the nature of the study, it is not possible to blind the participants and perform the intervention. But demographic information and anxiety measurement questionnaire will be done by a nurse outside the research team at the beginning of the intervention and then after assigning patients to the intervention group and controlling and performing the intervention, the data will be collected by a trained nurse outside the research team. The data is given to a statistician for analysis. The data collector and analyst will not be aware of how individuals are assigned to the groups.

Part of the demographic information of the patient can be shared after identifying individuals. All information related to measuring the anxiety of patient can be shared after identifying people.

Access period starts from June 2021

Researchers / medical students

Data for correlational studies

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Clear explanation of the reason for the need to access the data and submit the data after two weeks