The effect of family-centered empowerment model on stress, anxiety and family satisfaction in patients with Covid-19
Design
Clinical trial with control group, with parallel groups,Two blind, randomized, with a sample size of 30
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having coronavirus.
Non-Inclusion conditions: 1-Not willing to continue research.
Intervention groups
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.
Main outcome variables
stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180429039463N2
Registration date:2020-04-10, 1399/01/22
Registration timing:registered_while_recruiting
Last update:2020-04-10, 1399/01/22
Update count:1
Registration date
2020-04-10, 1399/01/22
Registrant information
Name
mohammad namazinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5222 5280
Email address
namazinm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-04-21, 1399/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment model on stress, anxiety and family satisfaction in patients with Covid-19
Public title
The Impact of Family-Based Empowerment Model on Stress, Anxiety and Satisfaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
39/5000The patient has coronavirus.
Exclusion criteria:
Do not want to participate in research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
دانشگاه های علوم پزشکی ایران
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
95196-33787
Approval date
2020-03-17, 1398/12/27
Ethics committee reference number
IR.THUMS.REC.1398.060
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
stress
Timepoint
Stress will be measured once before the first intervention and once after the last intervention session.
Method of measurement
Doss Stress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The Family-Based Empowerment Model, which will include four empowerment training sessions (2 45-minute sessions per week).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Nohome day Hospital, Torbat Heydarieh University of Medical Sciences
Full name of responsible person
محمد نمازی نیا
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95195481$6
Phone
+98 51 5222 6014
Email
mnamazi99@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Dr Hasann Azhdari Zarmehri
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95196-33787
Phone
+98 51 5222 8023
Email
azhdarizarmehri1@thums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Torbate-Heidaria University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
mohammad namazi nia
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh
City
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
Province
Razavi Khorasan
Postal code
95196-33787
Phone
+98 51 5222 6013
Email
mnamazi99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
mohammad namazi nia
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95169-33787
Phone
+98 51 5222 6013
Email
mnamazi99@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
mohammad namazi nia
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9519633787
Phone
+98 51 5222 6013
Email
mnamazi99@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main consequence after being unidentified will be shared
When the data will become available and for how long
Start the access period 6 months after Publish results
To whom data/document is available
Everyone
Under which criteria data/document could be used
The results obtained in this study can be used without restriction by researchers.
From where data/document is obtainable
Referring to Torbat Heidarieh Nursing and Midwifery Faculty
What processes are involved for a request to access data/document
After sending the email to the person responsible for the response process begins.