Protocol summary
-
Study aim
-
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
-
Complete the date of sampling
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20211110053030N2
Registration date:
2023-08-07, 1402/05/16
Registration timing:
registered_while_recruiting
Last update:
2024-06-11, 1403/03/22
Update count:
1
-
Registration date
-
2023-08-07, 1402/05/16
-
Registrant information
-
-
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
-
2023-07-16, 1402/04/25
-
Actual recruitment end date
-
2023-08-21, 1402/05/30
-
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
Actual sample size reached:
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
-
Ethics committees
1
-
Ethics committee
-
-
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)
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
1
-
Sponsor
-
-
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
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.
-
Comments
-