Comparative study of the efficacy of phototherapy (AVE) and cognitive rehabilitation on active memory and attention
Design
Clinical trials without control group, with a pre-test and post-test group, one blind, randomized
Settings and conduct
Cognitive rehabilitation and phototherapy by AVE are two of the new therapeutic approaches that can be tested and used to repair cognitive defects. This study was conducted in a psychiatric clinic in Yazd. We used Wechsler memory test to assess the memory and IVA test was used to assess the level of attention. Data was analyzed using independent covariance analysis and independent t-test. SPSS software was used to analyze the data. This study was conducted in a blinded way, so that the participants did not know about the difference between the two methods.
Participants/Inclusion and exclusion criteria
Students aged between 18-40 years old having no metal body in the head, no headache, no history of metal body in the head or heart pacemaker, no history of seizure or other neurological disorders, no major physical illnesses and no Substance abuse, no use of medications that affect the nervous system in the past six months
Intervention groups
1. Cognitive Rehabilitation Group with Cagni Plus software
2. Audio Visual Sync Group with AVE Device
Main outcome variables
Active memory
Attention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180409039245N1
Registration date:2019-04-15, 1398/01/26
Registration timing:retrospective
Last update:2019-04-15, 1398/01/26
Update count:0
Registration date
2019-04-15, 1398/01/26
Registrant information
Name
reyhaneh hosseinirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3629 0990
Email address
hosseini.rad@apk-group.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
2017-07-23, 1396/05/01
Actual recruitment end date
2017-09-22, 1396/06/31
Trial completion date
empty
Scientific title
Comparison of the effectiveness of visual-auditory synchronization and cognitive rehabilitation on active memory and attention in students
Public title
Comparison of the effectiveness of visual-auditory synchronization and cognitive rehabilitation on active memory and attention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria included: Students aged 18 to 40 years
Exclusion criteria:
metal implants in head
Headache
Heart pacemaker
History of seizure or other neurological disorders
Critical illnesses and substance abuse
Use of medications that affect the nervous system in the last six months
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
15
Actual sample size reached:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Thirty students were selected by purposive sampling method and allocated to two equal groups of cognitive rehabilitation (n = 15) and AVE (n = 15) using block randomization method
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were kept blind on the difference in the two methods of intervention, but the researcher was aware of this.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Research in Islamic Azad University Yazd Branch
Street address
Islamic Azad University of Yazd (IAUY), Shohada-e Gomnam Blvd, Professor Hesabi st, Safaie
City
Yazd
Province
Yazd
Postal code
8916871967
Approval date
2018-05-15, 1397/02/25
Ethics committee reference number
IR.IAU.YAZD.REC.1397،25
Health conditions studied
1
Description of health condition studied
Improve memory and attention
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
memory
Timepoint
two months
Method of measurement
Using Wechsler Memory Test
2
Description
attention
Timepoint
two months
Method of measurement
Using the IVA test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive Rehabilitation
Category
Rehabilitation
2
Description
Intervention group: Audio visual entrainment
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Yazd Psychological Consulting and Services Center
Full name of responsible person
Hossein Janeballahi
Street address
Montazere Ghaem, Blvd
City
Yazd
Province
Yazd
Postal code
-
Phone
+98 35 3724 0050
Fax
+98 35 3724 0050
Email
mirhoseini.h@gmail.com
Web page address
http://cps.yazdedu.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Imam Hossein Yazd Psychological Consulting and Services Center
Full name of responsible person
Navid Nasiryzadeh
Street address
Montazere Ghaem, Blvd
City
Yazd
Province
Yazd
Postal code
-
Phone
+98 35 3724 0050
Fax
+98 35 3724 0050
Email
mirhoseini.h@gmail.com
Web page address
http://cps.yazdedu.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Imam Hossein Yazd Psychological Consulting and Services Center
Proportion provided by this source
5
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Hamid Mirhosseini
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Neurology
Street address
Montazere Ghaem. Blvd
City
Yazd
Province
Yazd
Postal code
-
Phone
+98 35 3724 0050
Fax
+98 35 3724 0050
Email
mirhoseini.h@gmail.com
Web page address
http://cps.yazdedu.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Hamid Mirhosseini
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Neurology
Street address
Montazere Ghaem. Blvd
City
Yazd
Province
Yazd
Postal code
-
Phone
+98 35 3724 0050
Fax
+98 35 3724 0050
Email
mirhoseini.h@gmail.com
Web page address
http://cps.yazdedu.ir/
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Hamid Mirhosseini
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Neurology
Street address
MontazereGhaem. Blvd
City
Yazd
Province
Yazd
Postal code
-
Phone
+98 35 3724 0050
Fax
+98 35 3724 0050
Email
mirhoseini.h@gmail.com
Web page address
http://cps.yazdedu.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Memory scores and participants' attention in pre-test and post-test to examine the effects of interventions
When the data will become available and for how long
There is no time limit and can be used since publication.
To whom data/document is available
Researchers Related to This Thread
Under which criteria data/document could be used
In order to research more and more accurately
From where data/document is obtainable
Researcher responsible for this research
What processes are involved for a request to access data/document
Contact the researcher's email and submit the applicant's research documentation