Protocol summary
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Study aim
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The effect of scheduled online video meeting on anxiety, stress and depression in patients with COVID 19
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Design
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Clinical trial with control group, with parallel groups, double blind, randomized, with a sample size of 30
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Settings and conduct
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This study was performed on patients with COVID-19 who were admitted to Torbat Heydariyeh Hospital on the 9 dey.
On the first and second day of hospitalization in the COVID-19 support ward, video calls in the morning, evening and night shifts between the patient and the patient's family are made by the researcher's tablet in the ward and the patient's family's smartphone at home.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: COVID-19 disease and be sick on the first or second day of hospitalization. Conditions of non-entry: do not want to continue participating in the research and the impossibility of video communication more than 2 times in the intervention group.
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Intervention groups
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In the intervention group, on the first and second day of hospitalization in COVID-19 support ward, video call in morning, evening and night shifts and each shift once for 10-15 minutes between the patient and the patient's family by the researcher's tablet in the ward and the family smartphone The patient is performed at home. In the control group, communication with the patient's family is done by telephone and at times when the patient's condition and condition of the ward allow. Also, in both control and intervention groups, when the ward and patient conditions allow, the visitors can visit their patient in accordance with the principles of personal protection.
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Main outcome variables
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Stress, anxiety and depression
General information
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Reason for update
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End of sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180429039463N4
Registration date:
2022-04-10, 1401/01/21
Registration timing:
registered_while_recruiting
Last update:
2022-08-13, 1401/05/22
Update count:
1
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Registration date
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2022-04-10, 1401/01/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-04-04, 1401/01/15
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Expected recruitment end date
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2022-06-20, 1401/03/30
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Actual recruitment start date
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2022-04-04, 1401/01/15
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Actual recruitment end date
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2022-08-11, 1401/05/20
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Trial completion date
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2022-08-11, 1401/05/20
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Scientific title
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Evaluation of the effect of scheduled online video meeting on anxiety, stress and depression of patients admitted with Quaid 19
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Public title
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Evaluation of the effect of scheduled online video meeting on anxiety, stress and depression of patients admitted with Quaid 19
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having informed consent of patients to participate in the study
Patient consciousness
Ability to communicate verbally
No history of known anxiety and depression problems
Hospitalization with definitive diagnosis of Covid-19 for the first time
Having a smartphone connected to the Internet by the patient's family
The first or second day of hospitalization
Exclusion criteria:
Patients whose hemodynamic status is unstable
Loss of consciousness
Reluctance to continue cooperation in research
The patient needs vital measures such as intubation
Impossibility of video communication more than 2 times in the intervention group
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
30
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Dividing people into two groups randomly will be used by the random permutation block method. In this way, using blocks with two treatments and a table of random numbers, individuals were assigned to two groups of control and intervention. Then, the personal information questionnaire in both intervention and control groups is completed through interviews. This questionnaire includes information about personal characteristics and medical records (age, sex, type of disease, etc.).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, participants and outcome assessors did not know whether participants were in the control or intervention group.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-12-27, 1400/10/06
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Ethics committee reference number
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IR.THUMS.REC.1400.040
Health conditions studied
1
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Description of health condition studied
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Coronavirus disease
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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Depression
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Timepoint
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Depression is measured once at the time of admission and the second time 48 hours after admission.
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Method of measurement
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Depression is measured by Depression Anxiety and Stress Scales (DASS-21)
2
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Description
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Stress
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Timepoint
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Stress is measured once at the time of admission and the second time 48 hours after admission.
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Method of measurement
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Stress is measured by Depression Anxiety and Stress Scales (DASS-21)
3
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Description
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Anxiety
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Timepoint
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Anxiety is measured once at the time of admission and the second time 48 hours after admission.
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Method of measurement
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Anxiety is measured by Depression Anxiety and Stress Scales (DASS-21)
Intervention groups
1
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Description
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Intervention group: In the intervention group, during a face-to-face meeting of 10-15 minutes, the researcher gives the necessary training on the type of study and how to connect to the software and make video calls and visiting hours to the patient and his family. On the first and second day of hospitalization in Covid-19 support ward, video call in morning, evening and night shifts and each shift once for 10-15 minutes between the patient and the patient's family by the researcher's tablet in the ward and the patient's family's smartphone at home Done. Video calling is done using IMO software and at times when the patient's condition and ward condition allow. To avoid disturbing other patients, a handsfree is used to communicate between the patient and the family. Video communication is done when the patient is awake, as well as outside the time of nursing care and doctor visits.
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Category
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N/A
2
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Description
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Control group: In the control group, communication with the patient's family is done by telephone and at times when the patient's condition and condition of the ward allow. Also, in both control and intervention groups, when the ward and patient conditions allow, the visitors can visit their patient in accordance with the principles of personal protection.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Torbate-Heidaria University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information about the main consequence after being unidentified will be shared.
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When the data will become available and for how long
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Start the access period 6 months after Publish results
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To whom data/document is available
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Everyone
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Under which criteria data/document could be used
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The results obtained in this study can be used without restriction by researchers.
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From where data/document is obtainable
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Referring to Torbat Heidarieh Nursing and Midwifery Faculty
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What processes are involved for a request to access data/document
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After sending the email to the person responsible for the response process begins.
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Comments
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