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Evaluation of the Effect of Olfactory Training on Improving the Sense of Smell of COVID 19 Patients with Olfactory Dysfunction

Protocol summary

Study aim
Determining the effect of olfactory training on improving the sense of smell in patients with covid 19 with olfactory disorders
Design
A clinical trial with a control group, with parallel groups, using a simple randomization method with closed envelopes, consisting of 50 patients in the intervention group and 50 patients in the control group. There is no blinding.
Settings and conduct
100 patients who have reported a disorder in the sense of smell are divided into groups by a simple random method. Both groups complete the olfactory disorders questionnaire. Then the intervention group is subjected to olfactory training with four scents of rose, eucalyptus, clove, and lemon. Olfactory training is a method in which patients perform olfactory training for 6 weeks twice a day, morning and night, each scent for 20 seconds with a 10 second interval between each scent. The control group does not perform olfactory training during this period. After 6 weeks, both groups complete the olfactory disorders questionnaire again.
Participants/Inclusion and exclusion criteria
The conditions for patients to enter the study are over 18 years of age and a laboratory finding of covid 19 infection, who mention olfactory disorders and do not have a history of other diseases affecting the olfactory system, as well as the use of corticosteroids.
Intervention groups
The intervention and control groups both complete the questionnaire. Then the patients of the intervention group undergo olfactory training for 6 weeks. The control group does not receive olfactory training during this period. Then both groups are re examined by the questionnaire and the results are compared with each other.
Main outcome variables
Severity of olfactory disorder in patients with covid 19, The effect of olfactory disorder on quality of life, The effect of olfactory training on olfactory disorders caused by covid 19

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220803055612N1
Registration date: 2023-01-27, 1401/11/07
Registration timing: prospective

Last update: 2023-01-27, 1401/11/07
Update count: 0
Registration date
2023-01-27, 1401/11/07
Registrant information
Name
Mohammad hossein Akbarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3528 1966
Email address
mh.akbarpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-03-16, 1401/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Olfactory Training on Improving the Sense of Smell of COVID 19 Patients with Olfactory Dysfunction
Public title
Evaluation of the Effect of Olfactory Training on Improving the Sense of Smell of COVID 19 Patients with Olfactory Dysfunction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adult male and female (over 18 years old) who doesn't have a history of Olfactory Dysfunction before infection with Covid-19, a history of polyps in the nasal cavity, dependence on long term corticosteroids treatments for diseases such as Asthma and Chronic Obstructive Pulmonary Disease, a history of cerebrospinal fluid leakage, a history of Allergy to do not have Budesonide or other topical steroids Positive laboratory finding of Covid 19 Subjective complaint of loss of smell after infection The ability to read, write
Exclusion criteria:
patients with a history of Olfactory Dysfunction before infection with Covid 19, a history of polyps in the nasal cavity, dependence on long term corticosteroids treatments for diseases such as Asthma and Chronic Obstructive Pulmonary Disease, a history of cerebrospinal fluid leakage
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization, randomization unit: individual, randomization tool: Excel software, how to create a random sequence: using Excel's Rand function, concealment: in order to hide the random allocation using the method of sealed non-transparent envelopes Randomized sequence waxing (SNOSE) will be used.
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 Pharmacy and Nursing and Midwifery school of Shahid Beheshti University of Medic
Street address
Niayesh intersection, Valiasr st.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-06-21, 1401/03/31
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.059

Health conditions studied

1

Description of health condition studied
کووید 19
ICD-10 code
U07.1
ICD-10 code description
U07.1: COVID-19, Virus identified

Primary outcomes

1

Description
Score by Questionnaire of Olfactory Disorders - Negative Statements
Timepoint
Beginning and six weeks after
Method of measurement
Questionnaire of Olfactory Disorders - Negative Statements

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients who suffer from olfactory disorders Perform olfactory training, twice a day, in the morning and at night for 6 weeks, rotating for 20 seconds each with a ten-second interval between each scent, four scents of rose, eucalyptus, and cloves. and lemon.
Category
Treatment - Other

2

Description
Control group: Patients with covid-19 and olfactory disorders do not receive any treatment.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health deputy of Babol University of medical sciences
Full name of responsible person
Dr Mitra Zandi
Street address
Modarres
City
Babol
Province
Mazandaran
Postal code
1111111111
Phone
+98 11 1111 1111
Email
mh.akbarpour1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ali Ziai
Street address
Shahid Chamran Highway, Evin
City
Tehran
Province
Tehran
Postal code
193954719
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Hossein Akbarpour
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Pasdaran 10 st.
City
Babolsar
Province
Mazandaran
Postal code
4741858315
Phone
+98 11 3528 1966
Email
mh.akbarpour1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Hossein Akbarpour
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Pasdaran 10
City
Babolsar
Province
Mazandaran
Postal code
4741858315
Phone
+98 11 3528 1966
Email
mh.akbarpour1@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Hossein Akbarpour
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Pasdaran 10
City
Babolsar
Province
Mazandaran
Postal code
4741858315
Phone
+98 11 3528 1966
Email
mh.akbarpour1@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data on main outcomes can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
assessment of the effectiveness of the trainings 6 months after the study
From where data/document is obtainable
through the email address mh.akbarpour1@gmail.com
What processes are involved for a request to access data/document
the answer will be given one week after the requester sends an email to the mentioned email address.
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