The effectiveness of mandala coloring on the sleep quality of hemodialysis patients in dialysis centers affiliated to Khomein University of Medical Sciences
Determining the effect of mandala coloring on the sleep quality of hemodialysis patients
Design
The clinical trial with a control group, with parallel groups, without blinding, randomized, on 82 patients, was used for randomization from the sealed envelope site.
Settings and conduct
Dialysis centers affiliated to Khomein University of Medical Sciences
Participants/Inclusion and exclusion criteria
The criteria for entering the research include: confirmation of the disease according to the diagnosis of a neurologist; history of hemodialysis for at least 6 months and having consent to participate in the research; minimum literacy of reading and writing.
The criteria for leaving the research included: the inability of the patient to continue participating in the research for any reason; not wanting to continue cooperation. Changing the treatment method to peritoneal dialysis or Kidney transplant. Transfer to other medical centers; history of neurological disease.
Intervention groups
In the intervention group, for 4 sessions during 4 days in 2 weeks (two consecutive dialysis sessions per week), a mandala design will be done daily during dialysis for 30 to 60 minutes. In total, 4 identical designs are used for all people, but the use of designs in each session is at the discretion of the participants, and in fact, in each session, they can choose and color one of the 4 available designs. . And no intervention is done in the control group. At the beginning of the research, an explanation about mandala coloring and its effects and how to use it will be given to the participants. At the beginning of the mandala design, it is suggested to use colored pencils from the outside to the inside. . For this purpose, each participant will be given a box of 6 colored pencils
Main outcome variables
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240609062052N4
Registration date:2024-10-10, 1403/07/19
Registration timing:prospective
Last update:2024-10-10, 1403/07/19
Update count:0
Registration date
2024-10-10, 1403/07/19
Registrant information
Name
Pouya Zeidy
Name of organization / entity
Khomein University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 4633 2435
Email address
zeidypouya@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mandala coloring on the sleep quality of hemodialysis patients in dialysis centers affiliated to Khomein University of Medical Sciences
Public title
The effectiveness of mandala coloring on the sleep quality of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 6 months of hemodialysis experience
Consent to participate in the research
Literacy at least reading and writing
Exclusion criteria:
A history of neurodegenerative disease
The inability of the patient to continue participating in the research for any reason
Not wanting to continue cooperation
Changing the treatment method to peritoneal dialysis or kidney transplant. Transferring to other medical centers
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, random blocks will be used in order to hide the randomized allocation (concealment) and balance (balance) during and after the study. By using the sealedenvelope site and based on the sample size, people will be randomly placed in blocks of 4 and 6. The randomized list will be available only to the researcher as an Excel file.
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 Khomein Faculty of Medical Sciences
Street address
Azadi Avenue
City
Khomein
Province
Markazi
Postal code
3881743364
Approval date
2024-09-24, 1403/07/03
Ethics committee reference number
IR.KHOMEIN.REC.1403.024
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
2
Description of health condition studied
Acute kidney failure
ICD-10 code
N17
ICD-10 code description
Acute kidney failure
3
Description of health condition studied
Unspecified kidney failure
ICD-10 code
N19
ICD-10 code description
Unspecified kidney failure
Primary outcomes
1
Description
Sleep quality
Timepoint
The results are evaluated twice, once before the intervention from the time they entered the study and once after the intervention by the relevant questionnaire in the control and intervention groups.
Method of measurement
Pittsburgh Sleep Quality Questionnaire (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, for 4 sessions during 4 days in 2 weeks (two consecutive dialysis sessions per week), a mandala design will be done daily and during dialysis for 30 to 60 minutes. In total, 4 identical plans are used for all people, but the use of plans in each session is at the discretion of the participants And in fact, in each meeting, they can choose and color one of the 4 available designs. It is better to paint at the beginning of the morning and after waking up due to higher concentration. It is suggested to use colored pencils from outside to inside. For this purpose, each participant will be given a box of 6 colored pencils.
Category
Other
2
Description
Control group: In the control group, there is no intervention, and only the sleep quality of people like the intervention group will be measured at the beginning and end of the study (before and after the intervention).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Center of Hazrat Zahra Khomein Hospital
Full name of responsible person
Safarabadi Mahdi
Street address
Beheshti Blvd.
City
khomein
Province
Markazi
Postal code
3881955533
Phone
+98 86 4633 9982
Email
khomeinhospital@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khomein University of medical sciences
Full name of responsible person
Farahani Abbas
Street address
Quds
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
info@khomeinums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khomein 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
Khomein Faculty of Medical Sciences
Full name of responsible person
Mahdi Safar Abadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Quds square,khomein faculty of medical sciences
City
khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
mahdisafarabadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khomein Faculty of Medical Sciences
Full name of responsible person
Mahdi Safar Abadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Quds square,khomein faculty of medical sciences
City
khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
mahdisafarabadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khomein Faculty of Medical Sciences
Full name of responsible person
Mahdi Safar Abadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Quds square,khomein faculty of medical sciences
City
khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
mahdisafarabadi@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
All information and data will be shared after de-identifying people.
When the data will become available and for how long
Access will start 1 month after the results are published.
To whom data/document is available
All people related to medical and health matters
Under which criteria data/document could be used
The use of data will only be subject to mention of the source of the study and the authors.
It is definitely necessary to obtain permission from the authors and researchers of the study.
From where data/document is obtainable
With this email: mahdisafarabadi@gmail.com
What processes are involved for a request to access data/document
After submitting the request and explaining the reason for the request, Dr. Safarabadi, the scientific accountability officer, will review the request and finally, within 72 hours after the request, the result will be informed to the requester.