Investigation of effect of pulsed ultrasound on smell disorder in recovered patients of COVID 19
getting better of variable of smell disorder in recovered patients of COVID 19 based on IRAN- SIT score
Design
one intervention group and one controlled group and 15 patients in each group, single blinded, randomized
Settings and conduct
Tehran university medical science , war science center
Participants/Inclusion and exclusion criteria
age range:18 to 65
pass of 3 month of recovery or COVID 19
Intervention groups
Intervention group: recovered patients of COVID19 between 18 to 65 years old that intervened by continues ultrasound
Controlled group: recovered patients of COVID19 between 18 to 65 years old that don't intervene treatment and pelacebo
Main outcome variables
Smell disorder
Tthreshold of smell sense
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220406054434N1
Registration date:2022-05-15, 1401/02/25
Registration timing:prospective
Last update:2022-05-15, 1401/02/25
Update count:0
Registration date
2022-05-15, 1401/02/25
Registrant information
Name
Narjes Feizabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 7019
Email address
feizabadi.na@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-21, 1401/03/31
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Title : Effects of pulsed ultrasound on smell disorder in COVID-19
Public title
Title : Effects of pulsed ultrasound on smell disorder in COVID-19
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
remaining STD 3 month after recovery of COVID 19
Exclusion criteria:
malignancy in skull
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
ُُSimple randomization by selection chancing. Performing of randomization by clinician and selection of chancing by patient without patient's awareness about being in which group. randomization chancing are
After determination of total number of participants that is 30
numbers, 15 buoys showed by A and 15 buoys showed by B ere poured in a dish and pulled out via randomization and without replacement and this series is recorded. when a participant select a chance , in closed and dark packets which are gotten clinician, it will be adapted with the series then the group of participant will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyzer doesn't know about meaning of A& B and groups. because of the reason he or she is blinded about groups and study.
single blind via analyzer.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No. 7,Khayam Ended, Motalebinejad, West Akhlaghy kolahdooz Ave, Shemiranat Town
City
Tehran
Province
Tehran
Postal code
1939767773
Approval date
2022-03-16, 1400/12/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1520
Health conditions studied
1
Description of health condition studied
Smell disorder remained by COVID19
ICD-10 code
R43.0
ICD-10 code description
Anosmia
Primary outcomes
1
Description
smell disorder
Timepoint
first and end of intervention and follow
Method of measurement
IRAN-SIT Score
2
Description
threshold of smell sense
Timepoint
first and end of intervention and follow
Method of measurement
botanical test score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: treatment by continues ultrasound in wall airways with 1 Watt/Cm2 intensity and 4 minutes duration in each session in total 10 session
Category
Treatment - Other
2
Description
Control group: without treatment intervention, without pelacebo
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
War Research Center
Full name of responsible person
Feizabadi Narjes
Street address
No. 8 Khayam Ended , Motalebinejad West Akhlaghy Kolahdooz Ave.,Gholhak, Shemiranat Town
City
Tehran
Province
Tehran
Postal code
1937967773
Phone
+98 21 2264 7019
Email
FEIZABADI.NA@IUMS.AC.IR
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sahraeeyan Mohamadali: Research Assistant of Tehran University of Medical Science
Street address
Poursina , Ghods street, Enghelab, Tehran Town
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3334
Email
feizabadi.na@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Feizabadi Narjes
Position
Consaltant
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 8 ,Khayam Ended,Motalebinejad, West Akhlaghy, Kolahdooz Ave., Gholhak, ShemiranatTown
City
Tehran
Province
Tehran
Postal code
1939767773
Phone
+98 21 2264 7019
Email
feizabadi.na@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Feizabadi Narjes
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 8 Khayam Ended , Motalebinejad West Akhlaghy Kolahdooz Ave.,Gholhak, Shemiranat Town
City
Tehran
Province
Tehran
Postal code
1939767773
Phone
+98 21 2264 7019
Email
feizabadi.na@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Feizabadi Narjef
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 8, Khayam Ended, Motalebinejad , West Akhlaghy, Kolahdooz Ave., Gholhak., Shemiranat Town
City
Tehran
Province
Tehran
Postal code
1939767773
Phone
+98 21 2264 7019
Email
feizabadi.na@iums.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
all data for all patients and for both variables record exactly
When the data will become available and for how long
6 month after publication
To whom data/document is available
just for academic persons
Under which criteria data/document could be used
for use in clinical trial
From where data/document is obtainable
to corresponding author's email
What processes are involved for a request to access data/document