Are video games effective on cognitive performance and problem-solving ability in elderly with mild cognitive impairment?
Design
First, 6 video games based on the Android operating system will be evaluated by the nurse with the PANAS positive and negative aspects of video games questionnaire, and 3 games will be determined as the final games for the intervention group. became. Randomization will be done in four permutation blocks, and each group will have 30 participants. The implementation phase of the intervention will include playing three selected games for 12 weeks (3 times a week, 45 minutes each time). Questionnaires for examining the mental state and ability to solve problems before the intervention, eight weeks after the start of the intervention and four weeks after the end of the intervention will be collected from the people of both groups.
Settings and conduct
The place of sampling will be the neuropsychiatric clinic of Imam Khomeini Hospital in Ilam city, and the study will be continued at home by the samples.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate in the research; age 65 and older; score between 23 and 18 in MMSE to diagnose mild cognitive impairment; reading and writing literacy; owning a smart mobile phone with Android operating system; personal or first-degree relatives; score 8 and above in Geriatric Depression Scale (GDS).
Exclusion criteria: unwillingness to participate in the research or unwillingness to continue the research; absence of more than 2 sessions in the intervention; use of acetylcholinesterase inhibitors; use of antidepressants; death of the patient.
Intervention groups
Playing three selected games for 12 weeks (3 times a week, 45 minutes each time)
Main outcome variables
Cognitive performance; problem-solving ability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211110053030N2
Registration date:2023-08-07, 1402/05/16
Registration timing:registered_while_recruiting
Last update:2023-08-07, 1402/05/16
Update count:1
Registration date
2023-08-07, 1402/05/16
Registrant information
Name
Alireza Vasiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7091
Email address
rezawest10@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-16, 1402/04/25
Expected recruitment end date
2023-09-05, 1402/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of video games on cognitive performance and problem solving ability in the elderly with mild cognitive impairment
Public title
The effect of video games on cognitive performance and problem solving ability in the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 65 years
Having mild cognitive impairment (scoring 18 to 23 in MMSE)
Being literate in reading and writing
Having a smart personal cell phone
Obtaining a score of 8 and above in the GDS questionnaire
Exclusion criteria:
Unwillingness to participate or continue the research
Absence of more than 2 sessions in intervention
Taking antidepressants
Hospitalization during intervention
Use of acetylcholinesterase inhibitors
Having video games on a personal cell phone
Age
From 65 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning, the candidates to enter the study will be determined based on the entry and exit criteria, and then Balance-block randomization with 4 permutations will be used for random allocation. Blocks used include: 1. PPGG, 2. PGPG, 3. PGGP, 4. GGPP, 5. GPGP and 6. GPPG, in which the letter P (training) and the letter G (control) will be. RAS (Research Analysis and Statistics) software will be used to generate random blocks and a random number table will be used to select each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
After entering the samples into the study and random allocation, the researcher will be in charge of training the intervention group and during the study, he will answer the questionnaires and questions that may arise in connection with the intervention and assign the samples to each group. knows; However, the questionnaires are registered online during the study by a secretary and through phone calls, and the secretary does not know about the participants. The samples were also unaware of each other and they were asked to inform the family members and the main researcher during the study. Also, after the end of the study, the data analyst will receive the data in the form of coding and without knowing the type of study, he will perform the statistical analysis to check the outcome and during the absence of the main researcher to reduce the bias error as much as possible.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Ilam University of Medical Sciences
Street address
Pazhohesh Boulevard
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2023-07-15, 1402/04/24
Ethics committee reference number
IR.MEDILAM.REC.1402.094
Health conditions studied
1
Description of health condition studied
Mild cognitive impairment
ICD-10 code
F06.7
ICD-10 code description
A disorder characterized by impairment of memory, learning difficulties, and reduced ability to concentrate on a task for more than brief periods. There is often a marked feeling of mental fatigue when mental tasks are attempted, and new learning is found
Primary outcomes
1
Description
Mild cognitive disorder
Timepoint
Before the intervention, eight weeks after the start of the intervention, four weeks after the end of the study (the study is twelve weeks, and the final phase of completing the questionnaires is the sixteenth week, that is, four weeks after the end of the study)
Method of measurement
Mental Status Examination Questionnaires (MMSE), Geriatric Depression Scale (GDS)
2
Description
It refers to the mental process that people use to discover, analyze and measure the possibilities and solve the created problem with an innovative solution by using creativity and innovation. In this research, it means the score that a person gets in the Long and Cassidy problem solving questionnaire (PSQ)
Timepoint
before the intervention, eight weeks after the start of the intervention, four weeks after the end of the study (the study is twelve weeks, and the final phase of completing the questionnaires is the sixteenth week, that is, four weeks after the end of the study)
Method of measurement
Long and Cassidy Problem Solving Questionnaire (PSQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Playing three selected games for 12 weeks (3 times a week, 45 minutes each time)
Category
Rehabilitation
2
Description
Control group: Not receiving any educational intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ilam
Full name of responsible person
Alireza Vasiee
Street address
Ayatollah Heydari St
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3333 4500
Email
rezawest10@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Alireza Vasiee
Street address
Pazhohesh Boulevard
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7091
Email
rezawest10@gmail.com
Grant name
Vice President of Research and Technology of Ilam University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice President of Research and Technology of Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Alireza Vasiee
Position
Nursing Clinical Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pazhohesh Boulevard
City
Ilam
Province
Ilam
Postal code
631373847
Phone
+98 87 3222 7091
Email
rezawest10@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Alireza Vasiee
Position
Nursing Clinical Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pazhohesh Boulevard
City
Ilam
Province
Ilam
Postal code
6931373847
Phone
+98 84 3222 7091
Email
rezawest10@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Alireza Vasiee
Position
Nursing Clinical Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pazhohesh Boulevard
City
Ilam
Province
Ilam
Postal code
6931373847
Phone
+98 84 3222 7091
Email
rezawest10@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
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
At the end of the study, a decision will be made by the research team
When the data will become available and for how long
After completing the study and publishing the article
To whom data/document is available
After the end of the study, a decision will be made by the research team
Under which criteria data/document could be used
After finishing the study and publishing the article
From where data/document is obtainable
Refer to the email of the person responsible for registering the said trial
What processes are involved for a request to access data/document
After correspondence with the trial registrar, the research team will announce the final result to the person requesting the study information.