Protocol summary
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Study aim
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The effect of family-centered empowerment model on stress, anxiety and family satisfaction in patients with Covid-19
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Design
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Clinical trial with control group, with parallel groups,Two blind, randomized, with a sample size of 30
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Settings and conduct
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209/5000
In the intervention group, a family-based empowerment model that includes 4 empowerment training sessions (2 45-minute sessions per week) will be held. This model includes four steps of perceived threat, problem solving, educational participation, and evaluation.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Having coronavirus.
Non-Inclusion conditions: 1-Not willing to continue research.
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Intervention groups
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This study will be performed on the families of patients with Quaid 19 disease referred to the 9th Di Torbat Heydariyeh Hospital. Two complementary groups, then in the intervention group, family-based empowerment model, which will include 4 empowerment training sessions (2 45-minute sessions per week). This model includes four steps of perceived threat, problem solving, educational participation and evaluation. The focus will be on college classes.
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Main outcome variables
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stress
General information
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Reason for update
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The end date of sampling was recorded.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180429039463N2
Registration date:
2020-04-10, 1399/01/22
Registration timing:
registered_while_recruiting
Last update:
2021-05-04, 1400/02/14
Update count:
1
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Registration date
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2020-04-10, 1399/01/22
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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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2020-03-20, 1399/01/01
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Expected recruitment end date
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2020-04-21, 1399/02/02
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Actual recruitment start date
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2020-04-01, 1399/01/13
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Actual recruitment end date
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2020-07-25, 1399/05/04
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Trial completion date
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2020-07-31, 1399/05/10
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Scientific title
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The effect of family-centered empowerment model on stress, anxiety and family satisfaction in patients with Covid-19
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Public title
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The Impact of Family-Based Empowerment Model on Stress, Anxiety and Satisfaction
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
39/5000The patient has coronavirus.
Exclusion criteria:
Do not want to participate in research
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Age
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No age limit
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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:
30
Actual sample size reached:
70
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Randomization (investigator's opinion)
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N/A
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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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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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2020-03-17, 1398/12/27
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Ethics committee reference number
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IR.THUMS.REC.1398.060
Health conditions studied
1
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Description of health condition studied
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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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Stress will be measured once before the first intervention and once after the last intervention session.
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Method of measurement
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Doss Stress Questionnaire
Intervention groups
1
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Description
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Intervention group: The Family-Based Empowerment Model, which will include four empowerment training sessions (2 45-minute sessions per week).
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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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