Determination of serum levels of IFN-γ, IL-10 and miR-21 in patients with COVID-19 before and after relaxation intervention
Design
Using the available sampling method, the sample size is calculated and the serum level of the factors is measured before and after the intervention.
Settings and conduct
In this study, a sedative audio file will be played for patients with COVID-19 admitted to Ali-ebn-Abi Talib Hospital of Rafsanjan. Blood samples were taken from patients before and after the intervention and serum levels of IFN-γ, IL-10 and mir-21 Will be measured.
Participants/Inclusion and exclusion criteria
Patiants whose disease have been confirmed in terms of clinical findings and CT scan findings as well as RT-PCR test by a specialist and are under 80 years of age and their blood oxygen saturation is below 93% are selected for the study. Pregnant and lactating women will not be included in the study.
Intervention groups
In this study, a sedative audio file will be played for patients with COVID-19 and its effectiveness will be measured.
Main outcome variables
The main purpose of this study was to reduce stress in patients with COVID-19 using a sedative audio file and measuring serum levels of IFN-γ, IL-10 and mir-21. If this sedative audio file is effective, sedative audio files can be used to reduce patients' stress and help them to recover.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210413050959N1
Registration date:2021-08-17, 1400/05/26
Registration timing:prospective
Last update:2021-08-17, 1400/05/26
Update count:0
Registration date
2021-08-17, 1400/05/26
Registrant information
Name
Fatemeh Amin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0041
Email address
dramin@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of relaxtation on miR-21 expression and serum levels of IL-10 and IFN-γ in patients infected with COVID-19
Public title
Investigation the effect of relaxtation on miR-21 expression and serum levels of IL-10 and IFN-γ in patients infected with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patiants whose disease have been confirmed in terms of clinical findings and CT scan findings as well as RT-PCR test by a specialist
Confirmation of pneumonia by chest x-ray
Blood oxygen saturation below 93%
Relative stability of cardiovascular status
Exclusion criteria:
Disapproval of RT-PCR test
Dissatisfaction of patiants
The opinion of the treating physician to exclude the patient from the study
Decreased blood oxygen saturation below 85% while using a ventilator or nasal passage
People with underlying diseases
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University
Street address
Imam Ali Boulevard - Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
۷۷۱۷۹۳۳۷۷۷
Approval date
2021-07-28, 1400/05/06
Ethics committee reference number
IR.RUMS.REC.1399.211
Health conditions studied
1
Description of health condition studied
COVID-19 disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum levels of IL-10, MIR-21 and IFN-γ and patients' stress scores are measured before and after the intervention (listening to the audio file).
Timepoint
Serum levels of IL-10, MIR-21 and IFN-γ are measured before the intervention and 5 to 6 days after the intervention (listening to the audio file).
Method of measurement
Patients' stress levels and serum levels of IL-10, MIR-21 and IFN-γ F are measured using questionnaire and ELISA technique respectively.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patiants who listen to sedative audio file.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-ebn-Abi Talib Hospital of Rafsanjan
Full name of responsible person
Fatemeh Amin
Street address
Imam Ali Boulevard – Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
۷۷۱۷۹۳۳۷۷۷
Phone
+98 34 3428 0041
Email
ft.amin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemeh Amin
Street address
Imam Ali Boulevard – Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
۷۷۱۷۹۳۳۷۷۷
Phone
+98 34 3428 0041
Email
ft.amin@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemeh Amin
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Imam Ali Boulevard – Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
۷۷۱۷۹۳۳۷۷۷
Phone
+98 34 3428 0041
Email
ft.amin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemeh Amin
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Imam Ali Boulevard – Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
۷۷۱۷۹۳۳۷۷۷
Phone
+98 34 3428 0041
Email
ft.amin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemeh Amin
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Imam Ali Boulevard – Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
۷۷۱۷۹۳۳۷۷۷
Phone
+98 34 3428 0041
Email
ft.amin@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available