The effect of Sudoku game on the cognitive status of the elderly
Design
The trial of two groups is in parallel, which is done in the form of random blocks, random allocation for the thumbs of the participants in the study, according to the nature of the intervention, which is a game, there is no possibility of blinding people
Settings and conduct
The study is carried out as an intervention in the daily rehabilitation center of Yas elderly care in Tehran. The demographic questionnaire and the Montreal questionnaire will be provided to the participants after giving the necessary explanations. Then, the game table will be provided to the participants to solve. The participants will visit the center 2 days a week and play Sudoku for 1 hour under the supervision of the researcher. After the end of the sessions, the test will be taken again from the experimental group, due to the nature of the intervention, there is no possibility of blinding the participants
Participants/Inclusion and exclusion criteria
Inclusion criteria
Not using anti-depressants and anti-Alzheimer's drugs
Non-entry criteria
Reluctance to provide cooperation after the research process has started
Use of antidepressants and anti-Alzheimer's drugs during the study
Intervention groups
Playing the sudoku game, which is in the form of a 9x9 table, some of whose houses are filled with numbers 1 to 9. The goal is to fill the empty cells of the table so that, in the end, each number from 1 to 9 appears exactly once in each row, each column, and each 3x3 square. The people of the intervention group played this game for a period of They will do two sessions for one hour every 8 weeks
The control group used the center's routine training and did not receive any intervention
Main outcome variables
Cognitive status of the elderly
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240201060877N1
Registration date:2024-06-02, 1403/03/13
Registration timing:prospective
Last update:2024-06-02, 1403/03/13
Update count:0
Registration date
2024-06-02, 1403/03/13
Registrant information
Name
Akram Shakiba Saei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8872 1414
Email address
shakiba.akram@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-09, 1403/03/20
Expected recruitment end date
2024-08-10, 1403/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of sudoku game on cognitive situation of the elderly referring to the rehabilitation center
Public title
Investigating the effect of sudoku on the cognitive situation of the elderly
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to see and hear
Informed consent to participate in the rese
Ability to read and write
Not using antidepressants
Exclusion criteria:
Reluctance to provide cooperation after the research process has started
Use of anti-depressant and anti-Alzheimer drugs during research
Participation in less than 80% of meetings
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is block randomization. Considering that there are two groups of intervention and control, the size of the blocks is four, to create the blocks and sequence, spss software is used. After creating the blocks and sequence, the statistician Concealment of the created sequence. Each of the created sequences is placed in a sealed envelope that is not clear inside, and when a person with the conditions to enter the study enters, the door of the envelope is closed and the person is assigned to one of the envelopes. It should be noted that the person who assigns people to two groups is blinded and does not know which of the groups will receive the treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine - Islamic Azad University of Medical Sciences, Tehran (Research Ethics Committee
Street address
Quds settlement (West) between South Flamak and Zarafshan, Simai Iran Street, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
IR.IAU.TMU.REC.1402.269
Health conditions studied
1
Description of health condition studied
cognitive situation of the elderly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cognitive status
Timepoint
Before and after the intervention
Method of measurement
Montreal Cognitive Assessment Questionnaire
Secondary outcomes
1
Description
short term memory
Timepoint
Before and after the intervention
Method of measurement
Montreal Cognitive Assessment Questionnaire
2
Description
Decision-making power
Timepoint
Before and after the intervention
Method of measurement
Montreal Cognitive Assessment Questionnaire
3
Description
Spatial visualization
Timepoint
Before and after the intervention
Method of measurement
Montreal Cognitive Assessment Questionnaire
4
Description
Attention and concentration
Timepoint
Before and after the intervention
Method of measurement
Montreal Cognitive Assessment Questionnaire
5
Description
Behavioral memory
Timepoint
Before and after the intervention
Method of measurement
Montreal Cognitive Assessment Questionnaire
Intervention groups
1
Description
Control group: In the control group, they receive routine training at the Yas Center for the Elderly
Category
N/A
2
Description
Intervention group: The sudoku game table will be provided to the participants and the exercises will be done for 8 weeks and two sessions per week for one hour.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas Day Rehabilitation Center
Full name of responsible person
Adele Shirazi Khah
Street address
Sattar Khan Street, Alstom Power Plant, next to Gardhani
City
tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4428 0418
Email
www.yasrehab@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Asghar Dalundi
Street address
Sohank - Army Blvd. - Ghaem Square - Khandan St. - Salman St. - Velayat University Complex
City
TEHRAN
Province
Tehran
Postal code
1955847781
Phone
+98 21 2248 1602
Email
eco-lab@iauctb.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
When the article is published, the data is reported as a group. After publication, to conduct a larger study such as data meta-analysis and other analyzes that require individual data, the individual data is also available to other people without mentioning the names of the individuals.
When the data will become available and for how long
After printing the article
To whom data/document is available
People working in academic institutions and prestigious domestic and foreign scientific journals
Under which criteria data/document could be used
To conduct a larger study such as meta-analysis of data and other analyzes that require individual data
From where data/document is obtainable
Sending the request email to the responsible author Dr. Asghar Dalvandi at asghar.dalvandi@gmail.com
What processes are involved for a request to access data/document
After applying to the responsible author and confirming the first author, the data will be sent to the requesting people