This quasi-experimental study was performed on 60 family members of COVID-19 patients admitted to ICUs of medical centers affiliated with Zahedan University of Medical Sciences in 2021. The participants were selected using convenience sampling and randomly (limited random allocation) divided into intervention and control groups, each with 30 members.
The sample size was estimated as 3.29 persons per group based on the mean anxiety and stress scores as the main variables in a study by Navidian et al. with a 95% confidence interval and 95% statistical test power using the following formula (
20). However, to ensure sampling adequacy, considering the possible dropout, and the possibility of performing statistical analyses, the sample size in each group was considered to be 30 persons (60 persons in total):
The inclusion criteria were being a confirmed COVID-19 case, the admission of only one family member in the ICU, being a member of the patient’s immediate family, acting as the caregiver taking care of the patient and being involved in the treatment process, having minimum literacy and ability to use mobile phones and audio and video messaging systems, the passage of at least 48 hours after the patient’s admission, being at least 18 years old, not having a job in the healthcare system, no history of hospitalization or concurrent hospitalization of a family member in the hospital or ICU, not having any known psychiatric and physical illness, and not taking narcotics or neuroleptic drugs. Moreover, the main exclusion criteria were the discharge or death of the patient before 3 days, non-response of the caregiver to video and telephone calls, and the occurrence of a traumatic or tragic accident/event during the study.
The data in this study were collected using a demographic information form and the Hospital Anxiety and Depression Scale (HADS). The demographic information form assessed the patient’s and family members’ demographic information, including age, gender, marital status, education, occupation, kinship, and the number of hospital visits during the patient’s stay. The Hospital Anxiety and Depression Scale was developed by Zigmond and Snaith (
21). This self-report tool provides an intensive and rapid measure of anxiety and depression in non-psychiatric populations and groups and takes about 10 minutes to complete. The 14-item scale has a 7-item depression subscale and a 7-item anxiety subscale. The advantages of this tool are its shortness, easy scoring, and relative sensitivity to change. Each item has been formulated based on 4 options, and the respondent must choose the one that best describes his/her feelings. Each item is weighted on a four-point scale ranging from 0 to 3 (0 = almost never, 1 = sometimes, 2 = most of the time, and 3 = almost always). Accordingly, a score of 3 indicates a high level of anxiety or depression, and a score of 0 shows minimal anxiety or depression. Therefore, the total score on each subscale ranges from 0 to 21, with a higher score indicating a higher level of anxiety and depression (
21). This scale has been used in numerous studies and administered to different groups. The validity and reliability of this tool were reviewed and confirmed for use in Iran by Kaviani et al. (
18). Its validity was confirmed by determining its correlation with the Beck Anxiety Inventory (BAI) using a parallel-form test and clinical interviews with a psychiatrist. Moreover, its reliability was estimated by measuring internal consistency using Cronbach’s alpha with values of 0.70 and 0.85 for the depression and anxiety subscales, respectively (
18). In the present study, the reliability indices of the two subscales were measured using Cronbach’s alpha, and the corresponding values were 0.92 and 0.88, respectively.
After obtaining permission from the ethics committee and an introduction letter from the Vice-Chancellor for Research and Technology, the researcher was referred to hospitals affiliated with Zahedan University of Medical Sciences, including Khatam al-Anbia Hospital, Imam Ali Hospital, and Bu Ali Hospital. After making arrangements with hospital managers and nursing and ICU officials, and intensive care units, the sampling process began. The participants were selected using convenience sampling from the patients admitted to the ICUs based on the inclusion criteria and were randomly assigned to the intervention and control groups. Before sampling, blue (control) and red (intervention) balls were prepared for the total number of participants and randomly removed from a container to determine the group membership for each of the 60 patients and family members recorded on a list. Gradually, by referring to the intensive care units and identifying eligible individuals, the patients and family members were assigned to the related groups according to the prepared list.
A face-to-face meeting was held for the main caregiver of each patient with COVID-19 in the intervention group. If the family member met the inclusion criteria, he/she would be given some information about the study’s objectives and procedure. Written informed consent was then obtained from them to indicate their voluntary participation. In the face-to-face meetings, the items in the Hospital Anxiety and Depression Scale (HADS) were completed for the caregivers, and they were assured that the content of the audio and video messages sent would be deleted immediately and would not be made available to any person. The family members of the COVID-19 patients in the intervention group received daily information at an agreed hour about the general condition of the patient, the changes in the patients’ medical conditions/level of consciousness, diagnostic and therapeutic measures taken, and care received in the form of either audio or video messages upon the member’s preference. After sending the information, further explanations would be provided to clarify any possible issue or ambiguity or in response to questions asked by family members about the patient or the disease. The information was sent for 5 consecutive days. One day after the intervention, the HADS items were completed again as the post-test for the family members in person or by telephone. The patients and caregivers in the control group did not receive any intervention, and caregivers were informed about the patient and care process based on the routine ICU procedure. The HADS items were completed for the participants in the control group at the same time interval considered for the intervention group members. In order to prevent the possibility of bias, the scale was completed before and after the intervention for the participants in both groups by an assistant who did not know about the intervention.
The content of the messages was prepared mostly based on the common questions that would normally be asked from physicians and nurses by family members of COVID-19 patients admitted to the ICU and with a focus on the concerns raised by family members. Furthermore, following previous studies, issues such as changes in the patient’s consciousness level, medications, tests, oxygen saturation, care, diagnostic procedures, treatment processes, complications and consequences of the disease and hospitalization, disease process and prognosis, the probable time of the patient’s transfer to the general ward and discharge were further considered in audio and video messages in simple language based on the literacy and sociocultural status of the family members.
3.1. Ethical Considerations
The protocol for this study was approved by the Ethics Committee of Zahedan University of Medical Sciences, Iran, under the code IR.ZAUMS.REC.1400.173. To comply with ethical considerations, informed consent was obtained from the participants, and they were assured of the confidentiality of the information and that they would be free to leave the study at any stage.
3.2. Data Analysis
The collected data were analyzed with SPSS software (version 22) using the paired samples t-test, independent samples t-test, chi-square test, and analysis of covariance (ANCOVA) at the significance level of 0.05 (P = 0.05). The normality of the data was determined using the Shapiro-Wilk test.