Investigation effect of Internet-based psychoeducational support on perceived stress and caring burden in caregivers of COVID-19 patients.
Design
Superiority clinical trial, randomized controlled trial, using a random blocking allocation that cannot be blinded and sample size will 70 people.
Settings and conduct
The research will be performed in Shariati Hospital in Mashhad that conducted in six webinar sessions. Standard questionnaires of perceived stress, caring burden at the beginning and before the intervention and 14 days later are completed by both intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Caregiver age between 18-60.
No psychological disorders in the caregiver.
No drug addiction in the caregiver.
No hearing or vision impairment in the caregiver.
The caregiver should have the most contact with the patient in the post-discharge period.
Ability to access the Internet and online mass communication software.
Have the minimum ability to use smartphones and social networks.
Non-participation in other supportive interventions in the case of Covid-19.
The caregiver should not be a member of the health care system.
The caregiver is a family member of the patient.
Exclusion criteria:
Do not participate in the post-test.
Absence from more than two sessions in support sessions.
The reluctance of the caregiver to participate in the sessions.
Intervention groups
Intervention group 6 sessions of 35 to 45 minutes per day will be held in the form of the group video call. The content of support in 3 sessions is related to the field of education related to corona and in the field of psychological support during 3 sessions, in the form of stress management based on the theoretical basis of Lazarus and Folkman.
the control group will receive routine support.
Main outcome variables
Perceived stress, Caring Burden
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210109049978N1
Registration date:2021-01-13, 1399/10/24
Registration timing:prospective
Last update:2021-01-13, 1399/10/24
Update count:0
Registration date
2021-01-13, 1399/10/24
Registrant information
Name
Seyedmohammad Mirhosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
mirhoseinimh981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-18, 1399/10/29
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Internet- Based Psychoeducational Support on Perceived Stress and Caring Burden in Caregivers of Patients with COVID-19
Public title
Effect of Internet- Based Psychoeducational Support on Perceived Stress and Caring Burden in Caregivers of Patients with COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Caregiver age between 18-60.
No psychological disorders in the caregiver.
No drug addiction in the caregiver.
No hearing or vision impairment in the caregiver.
The caregiver should have the most contact with the patient in the post-discharge period.
Ability to access the Internet and online mass communication software.
Have the minimum ability to use smartphones and social networks.
Non-participation in other supportive interventions in the case of Covid-19.
The caregiver should not be a member of the health care system (such as doctors, nurses, midwives, etc.).
The caregiver is a family member of the patient.
Exclusion criteria:
Do not participate in the post-test.
Absence from more than two sessions in support sessions.
The reluctance of caregiver in participate in the sessions.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into intervention and control groups by random block allocation using quadruple blocks created by SPSS software version 24. According to the sample size of 70 in the present study, 18 quadruple blocks will be considered. Each caregiver will be randomly assigned to Group A (intervention) or B (control group) in the order determined by the software, and the sampling process will be performed sequentially until sampling is completed. Individuals are assigned to the target group in order of their entry into the study and randomly through randomized blocks.
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 Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery, Ibn Sina St.University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2020-10-06, 1399/07/15
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.051
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus not identified
Primary outcomes
1
Description
Perceived Stress
Timepoint
At the beginning of the study (before the intervention) and 14 days later.
Method of measurement
Cohen Perceived Stress Scale
2
Description
Caring Burden
Timepoint
At the beginning of the study (before the intervention) and 14 days later.
Method of measurement
Zarit Burden Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, 6 sessions of 35 to 45 minutes per day will be held in the form of group video call (webinar) which will be held in the form of lectures, group discussions, questions and answers, slide shows and clips. Supportive content in the field of education: (Introduction of Covid-19, personal protective equipment, providing care for patient with COVID-19 at home after discharge, nutrition management during COVID-19 crisis, providing care for the elderly, children during the COVID-19 crisis, principles of infection control and Disinfection, warning signs of the disease in those around and the patient in the recovery period, the patient taking medications) and in the psychological field of stress management program according to the theoretical model of stress management Lazarus and Folkman (1- Stress education and its effective factors 2- Supporting caregivers in identifying Stressful dysfunctional thoughts 3- Providing coping strategies (problem-oriented and emotion-oriented) to deal with stress 4- Providing support in applying the support provided in daily life and patient care). Data collection tools included demographic information form, Cohen Standard Perceived Stress Questionnaire (PSS-14) and Zarit Burden Inventory Questionnaire (ZBI) which on the first day after discharge, before the first session in the intervention group by all caregivers ( Intervention and Control Group) will be completed online. After 14 days of completing the questionnaires, the mentioned questionnaires will be completed to measure the effectiveness of the intervention on the web.
Category
Other
2
Description
Control group: They use the routine education of the medical center. Supporting contents will be provided to the control group after the intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Saeed Vaghee
Street address
Shariati Hospital, Imam Reza1 St, End Vakil Abad Blvd, dilemma Torghabeh and Shandiz, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩٣۵١٨٩٩٩٨٣
Phone
+98 51 3551 0010
Email
dshh.pr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreyshi building, Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Vaghee
Position
Assistant Professor of Nursing, Faculty member of Mashhad University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St.University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
vaghees@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Vaghee
Position
Assistant Professor of Nursing, Faculty member of Mashhad University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St.University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
vaghees@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedmohammad Mirhosseini
Position
MSc Student in nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St.University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
mirhoseinimh981@mums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some of the caregivers' demographic information can be shared after unidentifying individuals. All of the perceived stress and caring burden assessment information can be shared with caregivers after unidentified individuals.
When the data will become available and for how long
After publishing the article and defending the dissertation
To whom data/document is available
Project partners
Under which criteria data/document could be used
People who do similar research
From where data/document is obtainable
It will be done by email with the person in charge of the project.
What processes are involved for a request to access data/document