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"Investigating the effect of coloring mandala designs on working memory performance and attention control in the elderly"

Protocol summary

Study aim
Determining the effect of coloring mandala designs on working memory performance and attention control in the elderly
Design
A clinical trial with an intervention and control group, randomized groups, will be conducted on 76 elderly people. For randomization, the Randomization site will be used in blocks of four with replacement.
Settings and conduct
After preparing the sample size from nursing home centers, we will randomly divide the participants of each center into two intervention and control groups, and in this way, we will have intervention and control groups in each center. Then, in the intervention group, for 8 sessions and each session will be 30 minutes of coloring mandala designs, including coloring using patterns, and at the end of the eighth session, the N-Back test and continuous performance will be performed in the intervention group. will be completed. In the control group, only the routine measures of the center will be implemented for one month, and then, the N-Back test and continuous performance will be completed for the participants in the control group.
Participants/Inclusion and exclusion criteria
Age above 65 years score of 10-30 from the mini-mental state test Absence of mental disorder and severe cognitive disorder Having visual, auditory and motor skills Having the ability to read and write Consent of the participant to participate in the research
Intervention groups
In the intervention group, 38 elderly people living in nursing homes will paint mandala designs for 8 sessions and each session will last 30 minutes. In the control group, 38 elderly residents of the nursing home will receive the center's routine care for one month.
Main outcome variables
Working memory performance is measured in person using the N-back computer test as a pre-test and post-test. Attention control is measured using a continuous performance test as a pre-test and post-test in person.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240806062672N1
Registration date: 2024-08-11, 1403/05/21
Registration timing: prospective

Last update: 2024-08-11, 1403/05/21
Update count: 0
Registration date
2024-08-11, 1403/05/21
Registrant information
Name
Saeed Izadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5231 9735
Email address
saeedizady1379@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"Investigating the effect of coloring mandala designs on working memory performance and attention control in the elderly"
Public title
"Investigating the effect of coloring mandala designs on working memory performance and attention control in the elderly"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 65 years scoring 10-30 on the mini-mental state test (MMSE) absence of mental disorder (schizophrenia, severe depression) and severe cognitive disorder (dementia) and under treatment according to the medical record, having visual and hearing ability and upper movement (not suffering from rheumatoid arthritis, hand tremors and Parkinson's) having the ability to read and write the participant's consent to participate in the research
Exclusion criteria:
Age less than 65 years Having severe cognitive impairment Lack of visual, auditory and upper motor skills (not suffering from rheumatoid arthritis, hand tremors and Parkinson's disease)
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
The random sequence is generated by the Randomization site in blocks of four with replacement. Then this sequence is written on small cards and placed in the closed envelope. After entering the study, each qualified person opens the envelope and is placed in one of two groups based on the code on the card. This method continues until all people are assigned to two groups. In this method, the researchers do not know about its sequence. Also, the participants do not know which group they are in until they open the door of the envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
No. 13, 15 Mehr St
City
torbat heydarieh
Province
Razavi Khorasan
Postal code
9519957619
Approval date
2024-07-30, 1403/05/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.034

Health conditions studied

1

Description of health condition studied
Memory disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Working memory performance is measured face-to-face using the N-back computerized test as a pre-test and post-test at the beginning and end of the intervention.
Timepoint
in the form of pre-test and post-test at the beginning and end of the intervention with an interval of one month
Method of measurement
Using N-back computerized test

2

Description
Attention control is measured by using a continuous performance test in the form of pre-test and post-test at the beginning and end of the intervention by the project partner.
Timepoint
in the form of pre-test and post-test at the beginning and end of the intervention with an interval of one month
Method of measurement
Using computerized continuous performance testing

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: In the intervention group, for 8 sessions (2 sessions per week) and each session will be 30 minutes of coloring mandala designs, including coloring using patterns, and at the end of the eighth session, N-Back test and continuous performance in The intervention group will be completed.
Category
Rehabilitation

2

Description
Control group: In the control group, only the routine measures of the center will be implemented for one month, and after the end of one month, the N-Back test and continuous performance will be completed for the participants in the control group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tos elderly care and rehabilitation center
Full name of responsible person
afsaneh NikAkhtaran
Street address
Tos St., 35 Tos
City
mashhad
Province
Razavi Khorasan
Postal code
12345678910
Phone
+98 51 3691 0333
Email
saeedizady1379@gmail.com

2

Recruitment center
Name of recruitment center
farzanegan elderly care and rehabilitation center
Full name of responsible person
Mehdi SharifiNia
Street address
Mashhad, Esteghlal Square, Ibn Sina West Street, No. 232
City
mashhad
Province
Razavi Khorasan
Postal code
12345678910
Phone
+98 51 3606 7946
Email
saeedizady1379@gmail.com

3

Recruitment center
Name of recruitment center
salamati elderly care and rehabilitation center
Full name of responsible person
Mehla Tavasli
Street address
No. 116, between 62 and 64 Vakil Abad St
City
mashhad
Province
Razavi Khorasan
Postal code
12345678910
Phone
+98 51 3501 2449
Email
saeedizady1379@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Kharazmi Educational Complex
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Izadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mehr St. - 15 Mehr - No. 13
City
Torbat-e Heydarieh
Province
Razavi Khorasan
Postal code
9519957619
Phone
+98 51 5231 9735
Fax
Email
saeedizady1379@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Izadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mehr St. - 15 Mehr - No. 13
City
Torbat-e Heydarieh
Province
Razavi Khorasan
Postal code
9519957619
Phone
+98 51 5231 9735
Fax
Email
saeedizady1379@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Izadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mehr St. - 15 Mehr - No. 13
City
Torbat-e Heydarieh
Province
Razavi Khorasan
Postal code
9519957619
Phone
+98 51 5231 9735
Fax
Email
saeedizady1379@gmail.com

Sharing plan

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information related to working memory performance and attention control, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available for all researchers and people working in academic and scientific centers and institutions.
Under which criteria data/document could be used
The data will be available for all researchers and people working in academic and scientific centers and institutions.
From where data/document is obtainable
saeedizadi saeedizady1379@gmail.com
What processes are involved for a request to access data/document
People can request data through email and they will be answered as soon as possible.
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