Protocol summary
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Study aim
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Determining and comparing the effect of nurse supportive role on stress, anxiety and depression in the elderly with COVID- 19 admitted to Firoozabadi Hospital in Rey
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Design
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Non-randomized controlled trials was conducted with 78 subjects (39 in each group) .
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Settings and conduct
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In this study, 78 eligible elderly persons hospitalized in Firouzabadi Hospital were divided into group of experimental and control group (39 in each group). The control group received routine general patient education.
The experimental group, in addition to routine general patient education, received informational, emotional-spiritual and social support implementations by the researcher from 2nd to 5th day of hospitalization, daily, 8 - 10 AM (for one hour). Before the intervention and after the intervention, on the fifth day of hospitalization , Depression Anxiety and Stress Scale 21 (DASS-21) was completed in both experimental and control groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include:
Age over 60 years based on patient record , patient with COVID-19 on first day of hospitalization ,ability to dialect and understanding of Persian language score 7 or higher on abbreviated mental test (AMT).
non- inclusion criteria include: history of depression and psychological problems under medication according to information ,previous history of hospitalization due to COVID- 19 disease, use of barbiturates and anti-anxiety drugs during hospitalization
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Intervention groups
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Implementation of support in informational, spiritual, emotional and social fields daily and during the five days of hospitalization of the elderly patients 8 - 10 am (for one hour).
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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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The address and information I have entered has changed
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220609055119N1
Registration date:
2022-08-12, 1401/05/21
Registration timing:
retrospective
Last update:
2022-11-27, 1401/09/06
Update count:
1
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Registration date
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2022-08-12, 1401/05/21
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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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2022-03-16, 1400/12/25
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Expected recruitment end date
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2022-04-17, 1401/01/28
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Actual recruitment start date
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2022-03-16, 1400/12/25
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Actual recruitment end date
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2022-04-17, 1401/01/28
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Trial completion date
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2022-04-17, 1401/01/28
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Scientific title
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The effect of supportive role of nurse on stress, anxiety and depression in the hospitalized elderly with COVID-19 in Firoozabadi hospital at Rey city
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Public title
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The effect of supportive role of nurse on stress, anxiety and depression in the hospitalized elderly with COVID-19
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age over 60 years
Being infected with COVID-19
Patient consent for participating in the study
Getting 7 score or higher at abbreviated mental test(AMT )
First time hospitalized due to COVID-19 disease
Dialect and understanding of Persian language
The first day of hospitalization
Exclusion criteria:
Taking barbiturates and anti-anxiety or psychoactive drugs
History of depression and psychological problems under treatment
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Age
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From 60 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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No information
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Sample size
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Target sample size:
78
Actual sample size reached:
78
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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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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2022-03-05, 1400/12/14
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Ethics committee reference number
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IR.SHAHED.REC.1400.172
Health conditions studied
1
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Description of health condition studied
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Depression,Anxiety,Stress
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Stress
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Timepoint
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The first day (before intervention) and the fifth day of hospitalization (after intervention).
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Method of measurement
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Questionnaire 21 questions of stress, anxiety and depression
2
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Description
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Anxiety
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Timepoint
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The first day (before intervention) and the fifth day of hospitalization (after intervention).
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Method of measurement
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Questionnaire 21 questions of stress, anxiety and depression
3
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Description
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Depression
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Timepoint
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The first day (before intervention) and the fifth day of hospitalization (after intervention).
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Method of measurement
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Questionnaire 21 questions of stress, anxiety and depression
Intervention groups
1
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Description
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Control group: The patients received routine general education.
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Category
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Other
2
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Description
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Intervention group: In addition to receiving general routine training , the subjects received informational, spiritual, emotional and social support from 2nd day to 5th day of hospitalization during one hour, 8 - 10 AM, daily.
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Category
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Other
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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Shahed University
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Proportion provided by this source
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20
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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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The form of personal information including age, sex, marriage, number of children, level of education, income level, cohabitation status, underlying diseases and drugs used and percentage of lung involvement is available without mentioning patients' names and logos. A summary of how the research was conducted and its duration is available.
results of 21-item questionnaire on depression, anxiety; stress is available.
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When the data will become available and for how long
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After defending the thesis
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To whom data/document is available
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Students and researchers
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Under which criteria data/document could be used
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Research in a field similar to current research
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From where data/document is obtainable
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Visit the website of Shahed University or send a message to researcher's email. Zasa7090@yahoo.com
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What processes are involved for a request to access data/document
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It can be downloaded from the library of university .
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Comments
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