The effectiveness of cognitive-behavioral stress management using the remote care system (application) of Covid 19 patients on the severity and duration of symptoms of this disease, psychological symptoms, psychosocial adaptation, cognitive status and changes in the level of ferritin and CRP and Spo2 in the blood of Covid 19 patients.
Determining effectiveness of cognitive-behavioral stress management using the remote care system (application) of covid 19 patients on the severity and duration of symptoms of this disease, psychological symptoms, psychosocial adaptation, cognitive status and changes in the level of ferritin and CRP and Spo2 in the blood of covid 19 patients.
Design
Quasi-experimental study, with simple individual randomization using random number table tool in two groups of control and experimental, in parallel, one-way blind, with pretest and posttest, on 70 patients with covid 19
Settings and conduct
This research on covid 19 patients who have not been spend more than 5 days after the onset of their first symptoms and have been discharged from the Dr. gharazi isfahan hospital to continue quarantine at home and the mentioned psychological intervention is done online through the system (application) of remote care of covid 19 patients.
Participants/Inclusion and exclusion criteria
Covid 19 patients who have not been spend more than 5 days after the onset of their first symptoms and have been discharged from the hospital to continue quarantine at home and having a smartphone and being literate ; People who are too old or illiterate that to find information from them is difficult
Intervention groups
Cognitive-behavioral stress management using the remote care system (application) of covid 19 patients
Main outcome variables
severity and duration of symptoms of covid 19 disease; psychological symptoms; psychosocial adaptation; cognitive status; changes in the level of ferritin and CRP and Spo2 in the blood of covid 19 patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201205049610N1
Registration date:2022-11-19, 1401/08/28
Registration timing:retrospective
Last update:2022-11-19, 1401/08/28
Update count:0
Registration date
2022-11-19, 1401/08/28
Registrant information
Name
Hossein Hosseini naveh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3432 2616
Email address
mn.h.h.naveh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-04, 1399/10/15
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive-behavioral stress management using the remote care system (application) of Covid 19 patients on the severity and duration of symptoms of this disease, psychological symptoms, psychosocial adaptation, cognitive status and changes in the level of ferritin and CRP and Spo2 in the blood of Covid 19 patients.
Public title
Effect of cognitive-behavioral stress management on Covid 19 patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Covid 19 patients who have not been spend more than 5 days after the onset of their first symptoms and have been discharged from the hospital to continue quarantine at home.
Having a smartphone
Being literate
Exclusion criteria:
People who are too old or illiterate that to find information from them is difficult
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The sample people are selected by simple individual randomization by roll of a dice (numbers 1, 2 and 3 in the experimental group and numbers 4, 5 and 6 in 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
Research Ethics Committees of Islamic Azad University- Najafaba Branch
Street address
Islamic Azad University Blvd, Najafabad
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Approval date
2021-04-29, 1400/02/09
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1400.059
Health conditions studied
1
Description of health condition studied
Covid 19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Severity and duration of Covid 19 disease symptoms
Timepoint
Daily monitoring of symptoms of covid 19 disease, from the first day of entry into the study to 21 days
Method of measurement
Evaluation of symptom severity by daily fever measurement and body pain scoring with McGill Pain Questionnaire and weakness scoring with Energy / Fatigue subscale from Quality of Life Questionnaire. duration of covid 19 disease symptoms by daily symptom monitoring and number of days recorded that each of the subjects experiences symptoms
2
Description
Score of psychological symptoms (depression, anxiety and stress) in the 21-question questionnaire of depression, anxiety and stress Laweibond and Laweibond 1995
Timepoint
Perform pre-test before the intervention and post-test after the intervention
Method of measurement
Measurement of this variable using 21-question questionnaire of depression, anxiety and stress Laweibond and Laweibond 1995
3
Description
Psychosocial adaptation
Timepoint
Perform pre-test before the intervention and post-test after the intervention
Method of measurement
Measurement of this variable using the 160-question Bell Psychosocial Adjustment Questionnaire 1961
4
Description
cognitive status
Timepoint
Perform pre-test before the intervention and post-test after the intervention
Method of measurement
Measurement of this variable using the standard questionnaire of Mini-Mental State Examination of Folstein et al. 1975
5
Description
Changes in ferritin and C-reactive protein blood levels and saturation of peripheral oxygen of covid 19 patients
Timepoint
Perform pre-test before the intervention and post-test after the intervention
Method of measurement
Perform a blood test to check the serum level of ferritin and C-reactive protein in the blood and check the percentage of saturation of peripheral oxygen in the blood using a pulse oximeter in two stages, before and after the intervention.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: training cognitive and behavioral techniques for stress management using the covid 19 Remote Care System (application) that is given to these patients online
Category
Lifestyle
2
Description
Control group: for the control group, only routine medical and nursing care and recommendations and nutrition training is taught
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Gharazi Hospital of Isfahan
Full name of responsible person
Hossein Hosseini Naveh
Street address
Dr. Gharazi Hospital; Gharazi Avenue; Kaveh Boulevard
City
Isfahan
Province
Isfehan
Postal code
8196773365
Phone
+98 31 3491 2000
Email
gharazi.hos@tamin.ir
Web page address
https://www.tamin.ir/news/service/134
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Rafiei
Street address
Daneshgah Boulevard; Islamic Azad University Najafabad
City
Najaf Abad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2929
Email
info@iaun.ac.ir
Web page address
https://iaun.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Hossein Hosseini naveh
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.46; Unit 3; Mohammad Complex; Alley 5 (Salman); Stadium St; East Baharestan St; Kaveh St; Isfahan
City
Isfahan
Province
Isfehan
Postal code
8196773393
Phone
+98 31 3432 2616
Fax
Email
mn.h.h.naveh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Hosseini naveh
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.46; Unit 3; Mohammad Complex; Alley 5 (Salman); Stadium St; East Baharestan St; Kaveh St; Isfahan
City
Isfahan
Province
Isfehan
Postal code
8196773393
Phone
+98 31 3432 2616
Fax
Email
mn.h.h.naveh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Hosseini naveh
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.46; Unit 3; Mohammad Complex; Alley 5 (Salman); Stadium St; East Baharestan St; Kaveh St; Isfahan
City
Isfahan
Province
Isfehan
Postal code
8196773393
Phone
+98 31 3432 2616
Fax
Email
mn.h.h.naveh@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
All individual data of study participants will be shared after Unidentifiable Persons
When the data will become available and for how long
Access permission, three months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions, health care workers
Under which criteria data/document could be used
Use to conduct similar research or to discover relationships and correlations or to conduct structural equation research and path analysis
From where data/document is obtainable
Communicate with Mr. Hossein Hosseini Naveh at E.mail: mn.h.h.naveh@gmail.com
What processes are involved for a request to access data/document
Documents will be sent to their email by providing evidence of their Necessity need for data.