Determining the effect of family-centered education on stress and anxiety in caregivers of patients with COVID-19
Design
Study with a control group, community-based and pragmatic, with a parallel group, without blinding, randomized so that patients admitted on even days of the week to the experimental group and patients admitted on odd days to the group controls will be assigned.
Settings and conduct
Available sampling is performed in Behlool Hospital in Gonabad. In the intervention group,on the first and second days of hospitalization, caregivers will be trained on Covid disease, common symptoms, treatment and routes of transmission, and prevention methods.On the third and fourth days, caregivers are educated about post-discharge care and an educational pamphlet is given. Training sessions will be held for 30 minutes during the patient's hospitalization.The control group will conduct routine. At the end of the fourth day, DASS questionnaires will be completed again for groups.
Participants/Inclusion and exclusion criteria
Patient inclusion criteria: Diagnosis of COVID-19. Caregiver conditions: be a first-degree member of the family and the main caregiver of the patient; no history of illness and mental disorders; education at least the end of primary school; Lack of health jobs; no simultaneous care of another person; no hearing problems; age 18 to 70 years old; no family history of death due to COVID-19.Patient discharge criteria: death of the patient during the study, discharge of the patient less than 4 days. Exclusion criteria caregiver: unwillingness to continue cooperation; changing the patient's caregiver; getting sick with Covid-19.
Intervention groups
intervention group, a training program is performed for 4 days and for 30 minutes every day for patients' caregivers. control group, patients' caregivers will receive routine manner.
Main outcome variables
Stress and anxiety levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210202050219N1
Registration date:2021-04-08, 1400/01/19
Registration timing:registered_while_recruiting
Last update:2021-04-08, 1400/01/19
Update count:0
Registration date
2021-04-08, 1400/01/19
Registrant information
Name
Mohamad jamal Tayarani darbandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3623 8747
Email address
black.kourosh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered education on stress and anxiety of COVID-19 patients' caregivers
Public title
Investigating the effect of education on stress and anxiety of COVID-19 patients' caregivers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A primary family member and primary caregiver of patients admitted to the infectious diseases ward
No history of illness and mental disorders based on the patient's history and self-declaration
Education at least the end of elementary school
Lack of health jobs
Not taking care of another person at the same time
Have no hearing (full sitting despite the use of assistive devices) and visual (inability to read the newspaper at a distance of 30 cm with or without glasses) problems
Being in the age range of 18 to 70 years old
No family history of death due to COVID-19
Exclusion criteria:
Reluctance to continue cooperation
Change of person accompanying the patient (main caregiver)
Infection (main caregiver) of COVID-19 disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
In this way, patients who are admitted on even days of the week will be assigned to the experimental group and patients who are admitted on odd days of the week will be assigned to the control group.
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
Ethics committee of Gonabad University of Medical Sciences
Street address
Medical University of Gonabad, Imam Khomeini Avenue
City
Gonabad
Province
Razavi Khorasan
Postal code
9184113111
Approval date
2021-02-09, 1399/11/21
Ethics committee reference number
IR.GMU.REC.1399.118
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
2
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Stress score in the DASS questionnaire
Timepoint
Measurement of stress score at the beginning of the study (before the intervention) and day 4 after the intervention
Method of measurement
DASS questionnaire
2
Description
Anxiety score in the DASS questionnaire
Timepoint
Measurement of anxiety score at the beginning of the study (before the intervention) and day 4 after the intervention
Method of measurement
DASS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the family-centered training program will be implemented individually for caregivers of patients with COVID-19. The family-centered training program begins at the beginning of the patient's hospitalization. The researcher will stay with the family and answer their questions, concerns and feelings. On the first and second days of hospitalization, caregivers will be taught about the nature of COVID-19 disease, common symptoms, treatment, and ways of transmitting the disease, especially prevention methods when dealing with a patient. Third and fourth days in connection with post-discharge care, which includes patient care during quarantine, proper use of personal protection for the patient and family members, how to disinfect the environment, patient clothes and dishes, and proper diet for the patient and family members , Danger signs and the patient's return to the hospital, the caregivers are trained and the educational pamphlet prepared in this field is delivered to the patients.
Category
Other
2
Description
Control group: it will be treated according to routine and the educational intervention mentioned in the research will not be performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Behlool Gonabadi Hospital
Full name of responsible person
Reza Nouri
Street address
Allameh Behoul Gonabadi Hospital, Parstar Blvd., Saadi St.
City
Gonabad
Province
Razavi Khorasan
Postal code
9785296917
Phone
+98 51 5723 6833
Fax
+98 51 5723 6160
Email
bohlool@gmu.ac.ir
Web page address
http://bohlool.gmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosravan
Street address
Medical University of Gonabad, Imam Khomeini Avenue
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 0578
Email
info@gmu.ac.ir
Web page address
http://www.gmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Jamal tayarani Darbandi
Position
masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences,Imam Khomeini St,Khorasan Razavi, Gonabad,
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3513
Email
sdh@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Jamal tayarani Darbandi
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences,Imam Khomeini St.,Khorasan Razavi, Gonabad,
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 3623 8747
Email
black.kourosh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Jamal tayarani Darbandi
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Next to the Asian Road, Gonabad University of Medical Sciences, Gonabad, Iran
City
gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 3623 8747
Email
black.kourosh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available