Determining the effect of mandala staining on the anxiety of patients with COVID-19
Design
This research project is a randomized, controlled, double-blind, blind clinical trial with two parallel arms. They are randomly divided into intervention and control groups. And will be followed up for 6 days.
Settings and conduct
The study will be conducted in the wards of hospitalized patients with covid19 in Amir Al-Momenin Hospital. Studying on both sides will be double-blind. The intervention group included patients with Covid 19 who underwent Mandala staining for 6 consecutive days and 30 minutes each day. The control group included patients with Covid 19 who received only routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 15 to 60 years
Have mild to moderate anxiety
Stability of hemodynamic status
Exclusion criteria:
Lack of willingness to continue participating in the study
Patient discharge
Intervention groups
Intervention group: In this way, patients complete The State-Trait Anxiety Inventory -Spielberger questionnaire before starting the intervention, and then after 6 consecutive sessions of Mandala staining daily and every 30 minutes, The State-Trait Anxiety Inventory -Spielberger questionnaire is completed again and their anxiety is measured.Control group: In this group, patients do not receive any intervention from the researcher and only receive routine care.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180519039711N6
Registration date:2020-06-29, 1399/04/09
Registration timing:prospective
Last update:2020-06-29, 1399/04/09
Update count:0
Registration date
2020-06-29, 1399/04/09
Registrant information
Name
Mohamad Golitaleb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3506
Email address
m.golitaleb@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-19, 1399/04/29
Expected recruitment end date
2020-10-20, 1399/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of Mandala Coloring on Anxiety in Patients with COVID-19: A Randomized Clinical Trial
Public title
Effect of mandala staining on anxiety in patients with COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 15 to 60 years
Have mild to moderate anxiety
Stability of hemodynamic status
Exclusion criteria:
Lack of willingness to continue participating in the study
Patient discharge
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into intervention and control groups. Sixty patients were randomly assigned to either the intervention or control groups, initially 6 blocks of 10 different T and C letters (which represent the intervention and control groups) (30) from the intervention group and 30 from the intervention group. People belong to the control group). Then, the blocks were randomly selected to obtain a 60-sided combination of blocks. It opens to tell which group the patient falls into.
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical caregivers, data analysts, and patients are not aware of being in the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Deputy of Education and Research,Campus University of Medical Sciences site,Basij square,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-05-31, 1399/03/11
Ethics committee reference number
IR.ARAKMU.REC.1399.089
Health conditions studied
1
Description of health condition studied
Covid 19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Anxiety
Timepoint
At the beginning of the study and 6 days after the intervention
Method of measurement
The State-Trait Anxiety Inventory -Spielberger
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The researcher will use Mandala staining to investigate its effect on the anxiety of patients with hospitalized Covid-19. In this way, patients complete The State-Trait Anxiety Inventory -Spielberger questionnaire before starting the intervention, and then after 6 consecutive sessions of Mandala staining daily and every 30 minutes, The State-Trait Anxiety Inventory -Spielberger questionnaire is completed again and their anxiety is measured.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Fatemeh Khademi
Street address
Basij square. Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/amirhos/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. alireza kamali
Street address
Education and Research Deputy of Arak University of Medical Sciences, Basij Square, Arak
City
Arak
Province
Markazi
Postal code
+98 86 3313 6055
Phone
+98 86 3313 6055
Fax
+98 38 1969 3345
Email
info@arakmu.ac.ir
Web page address
http://arakmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mohamad Golitaleb
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences. Basij square. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Fax
+98 86 3417 3503
Email
mohamadgolitaleb@gmail.com
Web page address
http://arakmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohamad Golitaleb
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences. Basij square. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Fax
+98 86 3417 3503
Email
mohamadgolitaleb@gmail.com
Web page address
http://arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohamad Golitaleb
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences. Basij square. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Fax
+98 86 3417 3503
Email
mohamadgolitaleb@gmail.com
Web page address
http://arakmu.ac.ir
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Shared data including demographic and disease information, type and method of intervention, information about sleep quality of participants before and after intervention.
When the data will become available and for how long
Start the access period 6 months after the results are published.
To whom data/document is available
Researchers and people working in nursing education as well as nursing clinical staff.
Under which criteria data/document could be used
The data can be used for education, research and clinical nursing. The applicant must be in the nursing field The data applicant only uses data for teaching, research and clinical nursing.
From where data/document is obtainable
Mohamad golitaleb,Department of critical care nursing,school of nursing,Arak university of medical sciences E mail:Mohamadgolitaleb@gmail.com Tel:+989379366279
What processes are involved for a request to access data/document
After ensuring that the data applicant is in the nursing field, we will be immediately responded to the request form by email.