Protocol summary

Study aim
effect of odor stimulation on naming skill in aphasic patients
Design
We use a clinical trial with ten aphasic individuals.
Settings and conduct
The place for all evaluation and intervention's sessions is the Semnan university speech and language therapy clinic. the Nilipour naming test administrates in 3 times before the start of intervention, 2 times before and after a presentation of unpleasant odor, 2 times before and after a presentation of the pleasant odor.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aphasic patients with naming deficit exclusion criteria: recurrent stroke and bilingual
Intervention groups
The aim of this study is to investigate the efficacy of odor stimulations on naming skill in aphasic patients.
Main outcome variables
naming skill

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151122025194N5
Registration date: 2018-09-01, 1397/06/10
Registration timing: retrospective

Last update: 2018-09-01, 1397/06/10
Update count: 0
Registration date
2018-09-01, 1397/06/10
Registrant information
Name
Shohre Kaviani Tehrani
Name of organization / entity
Semnan University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
kaviani@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-21, 1397/04/30
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of odor stimulations on naming skills in aphasic patients.
Public title
effect of odor in aphasic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40 until 65 years old stroke resulted in aphasia Maximum 4 months after stroke presence of naming deficit right handed normal or corrected vision and hearing ability mono language (Persian) able to read and write.
Exclusion criteria:
History of drug abuse in the past 6 months history of mental illnesses history of psychotropic drug abuse recurrent stroke
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
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 Semnan University of Medical Sciences
Street address
Semnan University Of Medical Science, Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2018-06-12, 1397/03/22
Ethics committee reference number
IR.SEMUMS.REC.1397.004

Health conditions studied

1

Description of health condition studied
aphasia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
naming skill
Timepoint
3 times before the start of intervention, 2 times before and after a presentation of unpleasant odor, 2 times before and after a presentation of the pleasant odor
Method of measurement
The Nilipour Naming Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: aphasic patients; presentation of pleasant and non-pleasant odor and investigation of naming score.The two odors using in this experiment: vanilla (as pleasant odor stimuli) and fish tuna (as non- pleasant odor stimuli). For each odor, patients were asked to breathe normally and naming same word list and their responses score. each odor test per a day.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center, Rehabilitation Faculty Semnan University Of Medical Sc
Full name of responsible person
Shohre Kaviani Tehrani
Street address
Semnan University Of Medical Science, Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3365 4180
Fax
Email
Shohrekaviani@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz kokhai
Street address
Semnan University Of Medical Science, Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3365 4180
Email
Shohrekaviani@gmail.com
Grant name
Vice chancellor for research, Semnan University Of Medical Science
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Shohre Kaviani Tehrani
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Semnan University Of medical Science, Damghan road, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3365 4180
Email
Shohrekaviani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
shohre kaviani tehrani
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Semnan University Of Medical Science, Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3365 4180
Fax
Email
Shohrekaviani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
shohre kaviani tehrani
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Semnan University Of Medical Science, Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3365 4180
Email
Shohrekaviani@gmail.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
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
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
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