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The effect of Auriculotherapy on Clinical finding of Covid 19

Protocol summary

Study aim
Determination of the effect of orchicotherapy on the clinical course of patients with suspected covid 19
Design
Clinical trial with control group, with parallel, randomized groups, on 70 patients. The random number table was used for randomization.
Settings and conduct
Infectious Diseases Section for covid19, Shahid Sadoughi Hospital in Yazd
Participants/Inclusion and exclusion criteria
Entry criteria: patients admitted to the infected areas suspected of having covid 19; age 10 to 70 years old; having CT scan of the lungs; having a healthy double ear (for orchicotherapy); self-expression of participants for: no depression; no use of antidepressants; no pace maker; not having Platinum or metal in body Lack of entry criteria: swelling, infection, and sores in both ears in the intervention group, use of psychotropic drugs, antidepressants, stressful events such as: death of loved ones, adverse events, tendency to terminate treatment, worsening of the patient's condition And the need for an instance in the ICU
Intervention groups
In the intervention group after disinfection of the ear with 70% alcohol, spots (Thymus gland, Adrenal, lung 1 & 2, Throat, internal nose, larynx, Trachea, (left) Shenmen, zero point, thalamus point, Anxiety point, sensorial, vitality sing (right)) is stimulated for 15 seconds by POINTER EXCEL. After orchiotherapy, the seed or Seyed Vakariber is placed on the desired points. And is pressed by the patient every hour for one minute to seven days.
Main outcome variables
Anxiety; sleep quality; shortness of breath; cough; arterial oxygen levels

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180608040007N2
Registration date: 2020-06-13, 1399/03/24
Registration timing: registered_while_recruiting

Last update: 2020-06-13, 1399/03/24
Update count: 0
Registration date
2020-06-13, 1399/03/24
Registrant information
Name
Maryam Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
maryammohammadi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-28, 1399/02/09
Expected recruitment end date
2020-06-29, 1399/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Auriculotherapy on Clinical finding of Covid 19
Public title
Effect of Auriculotherapy in treatment of Covid 19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients hospitalized for infectious parts suspected of having covid 19 Age from 10 to 70 years Having a healthy double ear (for uricotherapy) Participants self-reported for: no depression, no psychotropic medications, no pacemakers, no platinum or no metal objects in the body
Exclusion criteria:
Swelling, infection and sores in both ears in the intervention group Use of psychotropic drugs, antidepressants Occurrence of stressful events such as the death of loved ones, unfortunate events The desire to end treatment Worsening of the patient's condition and the need for an ICU
Age
From 10 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
Based on the entry and exit criteria, 70 patients suspected of having corona are selected from seven infected wards activated in the hospital and then divided into two groups (35 patients in the test group and 35 patients in the control group) based on the table of random numbers.
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
Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Central Organization of Shahid Sadoughi University of Medical Sciences and Health Services, Dr. Shahid Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-04-28, 1399/02/09
Ethics committee reference number
IR.SSU..REC.1399.030

Health conditions studied

1

Description of health condition studied
covid19
ICD-10 code
P07.14
ICD-10 code description
COVID 19

Primary outcomes

1

Description
Improving the clinical course
Timepoint
Daily control of clinical symptoms up to 7 days after uricycliotherapy
Method of measurement
Arterial oxygen with pulse oximeter, anxiety with questionnaire, sleep quality with questionnaire,

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:First, 15 minutes is explained about orchicotherapy, and after disinfecting the ear with 70% alcohol and drying the spots: Thymus gland, Adrenal, lung 1 & 2, Throat, internal nose, larynx, Trachea, (left) Shenmen, zero point, thalamus point, Anxiety point, sensorial, vitality sing (right) is stimulated by the device (POINTER EXCEL (II) for 15 seconds. After uriculotherapy, the seed or Seyed Vakariber is placed on the desired points. It stays on the ear for seven days and it is recommended that each seed be pressed once every 1 hour for 1 minute.
Category
Treatment - Other

2

Description
Control group: Routine treatments are performed and no new intervention is performed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital in Yazd
Full name of responsible person
Maryam Mohammadi
Street address
Ibn Sina Boulevard, Safaieh,
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
ba_zendegy@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masoud Mirzaei
Street address
Central Organization of Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Shahid Dr. Bahonar Square -
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Maryam Mohammadi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ibn Sina Boulevard, Safaieh
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
ba_zendegy@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Mohammadi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ibn Sina Boulevard, Safaieh
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
ba_zendegy@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Bagher Khani
Position
Supervisor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ibn Sina Boulevard, Safaieh
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
ba_darya@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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
outcomes
When the data will become available and for how long
After the publication of the article in the journal
To whom data/document is available
Researchers in the Department of Medical Sciences
Under which criteria data/document could be used
Tips for treating other patients
From where data/document is obtainable
Email ba_zendegy@yahoo.com Maryam Mohammadi
What processes are involved for a request to access data/document
Send messages via email.
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