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"The Effect of Mandala-Style Coloring on Cognitive Function in the older adults"

Protocol summary

Study aim
The effect of mandala-style coloring on the cognitive function of the elderly
Design
Clinical trial with a control group, with parallel groups, randomized, sample size 42 people, randomization with four-way permutation blocks,
Settings and conduct
Elderly people will be selected from among the elderly in Gonabad city based on the inclusion criteria and randomly assigned to two study groups. After obtaining written consent, the intervention group will color ready-made mandala designs (one design per session, a total of 16 designs) with 6 colored pencils for 2 sessions per week for 8 weeks, 20 minutes each session. The control group will also color freely with black pencils during the same period.
Participants/Inclusion and exclusion criteria
Age over 60, visual and motor ability, giving informed consent, having mild to moderate cognitive impairment
Intervention groups
Intervention group: Coloring predetermined mandala designs with colored pencils, control group: Drawing with black pencils without a specific design.
Main outcome variables
Change in cognitive performance scores in the elderly

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251213068299N1
Registration date: 2025-12-25, 1404/10/04
Registration timing: prospective

Last update: 2025-12-25, 1404/10/04
Update count: 0
Registration date
2025-12-25, 1404/10/04
Registrant information
Name
zohre nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8844 6697
Email address
zohrenazari1402@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-14, 1404/10/24
Expected recruitment end date
2026-03-04, 1404/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"The Effect of Mandala-Style Coloring on Cognitive Function in the older adults"
Public title
"The Effect of Mandala-Style Coloring on Cognitive Function in the older adults"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the research and providing written consent to participate in the research. Having mild cognitive impairment (based on studies, a score of 24 (sometimes 23-25) is suspicious of cognitive impairment on the Montreal Cognitive Assessment Questionnaire). Absence of severe mental disorders or advanced dementia (based on family statements). Having the necessary physical and mental ability to perform the coloring activity. The ability to see and recognize mandala designs. Ability to communicate. No chronic diseases. Avoid taking medications that affect memory and cognitive function. No previous experience in coloring mandalas. Having at least basic reading and writing skills.
Exclusion criteria:
Physical or psychological problems that may prevent staining from occurring during the study. Unwillingness to continue research. Absence from more than two intervention sessions. Starting medications that affect cognitive function. The coloring process may cause significant stress or anxiety for the elderly person.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
They will be assigned to two intervention and control groups using four-way permutation blocks.for this purpose, the intervention group will be assigned the letter A and the control group will be assigned the letter B. The possible states in the four-state block of six states include AABB, BBAA, ABAB, BABA, ABBA, BAAB, each state will be written on a card and assigned to cards numbered one to six. Then, one of the six possible states will be selected using dice and the selected patients will be divided into two groups based on that. This process will continue until the sample size is completed.
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 Gonabad University of Medical Sciences
Street address
Imam Khomeini Street, Ghadir Square, Gonabad.
City
Gonabad
Province
Razavi Khorasan
Postal code
969169996
Approval date
2025-12-08, 1404/09/17
Ethics committee reference number
IR.GMU.REC.1404.103

Health conditions studied

1

Description of health condition studied
Mild Cognitive Impairment
ICD-10 code
G31.84
ICD-10 code description
Mild Cognitive Impairment, so stated

Primary outcomes

1

Description
Cognitive Function Of Older Adult
Timepoint
Before And After Intervention
Method of measurement
Montreal Cognitive Assessment Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Coloring mandala designs with 6 colored pencils, twice a week for 20 minutes for up to two months.
Category
Behavior

2

Description
Control group: Free coloring with black pencil without a specific pattern twice a week in 20-minute sessions for up to two months.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Vice President of Health, Gonabad University of Medical Sciences
Full name of responsible person
Javad Sadeghi Nasab
Street address
Naserkhosro Ave
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0912
Fax
Email
sadeghinasab.j@gmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ali Firoozi Chahak
Street address
Next to the Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-93718
Phone
+98 51 5722 3028
Email
ali_firoozi66@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
1
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
Gonabad University of Medical Sciences
Full name of responsible person
Zohre Nazari
Position
Post graduate student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Next to the Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 4946
Email
zohrenazari1402@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hossein Ajam Zibad
Position
associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Next to the Asian Road, Faculty of Nursing, Gonabad University of Medical Sciences.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3814
Email
moallef@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Zohre Nazari
Position
Master's Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Side of Asian Road, Gonabad University of Medical Sciences.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3084
Email
zohrenazari1402@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Due to ethical considerations and to maintain the confidentiality of participant information, individual data from this study cannot be shared publicly. However, aggregated, de-identified data will be available upon request and with the approval of the lead researcher.
When the data will become available and for how long
The period of access to de-identified documents and data begins 6 months after the publication of the final results of the thesis, and this access will be maintained for 5 years.
To whom data/document is available
Requests for access to data are only possible by researchers working in reputable academic and research centers, and will be made after reviewing the research purpose and with the approval of the responsible researcher and the ethics committee.
Under which criteria data/document could be used
Access to data is subject to a formal request with a specific research purpose, and data use is permitted only for scientific, non-commercial purposes and within the framework of the stated goals. Confidentiality of information, no attempt to re-identify individuals, and final approval by the responsible researcher are mandatory.
From where data/document is obtainable
Applicants can submit their formal request through correspondence with the researcher responsible for the project via the email address listed in the IRCT system and, after review and approval, proceed to receive non-identifiable documents or data.
What processes are involved for a request to access data/document
After submitting the official request, the request will be reviewed by the responsible researcher within a maximum of 2 to 4 weeks, and if approved, de-identified data will be provided to the applicant.
Comments
There are no further details regarding data sharing.
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