The effect of Mandala staining on the anxiety of mothers with hospitalized neonatal care unite
Design
Clinical trial with a control group, with parallel groups, a blind strain, randomized on 90 patients. Sealed Envelope software will be used for randomization.
Settings and conduct
This study will be conducted in the educational center of Imam Khomeini hospital in Arak. After coloring by the intervention group, their anxiety level is measured and recorded. Only the analyzers do not know how the samples are placed in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study, Having the ability to paint, Having a baby in the neonatal intensive care unit, Age over 20 years to 45 years؛ Exclusion criteria: Suffering from anxiety and obsessive disorders, Having twins or multiples
Intervention groups
Intervention group: Demographic information and Spielberger anxiety questionnaires are completed by this group before and after the intervention. Coloring will be done only for the intervention group. How to paint and participate in the study is fully explained to the mothers by the researcher, and the mothers in the intervention group are asked to start painting in a private and quiet place. Coloring three times a week and each time for at least 15 minutes. Control group: They do not receive this intervention during this period. Spiel Berger's anxiety questionnaire is completed again by mothers in both groups after the intervention.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210501051142N5
Registration date:2022-11-07, 1401/08/16
Registration timing:prospective
Last update:2022-11-07, 1401/08/16
Update count:0
Registration date
2022-11-07, 1401/08/16
Registrant information
Name
Aida Arjloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
golmehrsherafati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Mandala staining on the anxiety of mothers with hospitalized neonatal care unite
Public title
The effect of Mandala staining on the anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Having the ability to paint
Having a baby in the neonatal intensive care unit
Age over 20 years to 45 years
Exclusion criteria:
Suffering from anxiety and obsessive disorders
Having twins or multiples
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Mothers are assigned to groups in the order of arrival and based on the randomization sequence that will be generated in advance. This sequence is unpredictable and does not have a specific pattern, and its arrangement is completely random. To assign the samples to two groups, the block randomization method will be used with a block size of 4, so that by using the random number generation software in the block method, the randomization sequence will be produced according to the required sample size for the two groups. First, all the states where two letters A and B can be arranged together in a block of 2 are created, and a block is randomly selected by placing it between the blocks, and from the arrangement pattern in that block for Child allocation is used then this block will be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups that the researcher will not be able to predict which group the next person will be in.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will not know how the samples are placed in the intervention and control groups. Other people in the study will be aware of this placement.
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
Arak university of medical sciences, Basij Sq., Sardasht region
City
Arak
Province
Markazi
Postal code
3848176593
Approval date
2022-05-15, 1401/02/25
Ethics committee reference number
IR.ARAKMU.REC.1401.056
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Average anxiety score
Timepoint
Three times a week and each time for at least 15 minutes
Method of measurement
At the beginning and end of the study, the demographic questionnaire and the Spiel Berger questionnaire were completed by the mothers of both groups and based on this, the anxiety level of nurses is determined.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Demographic information and Spielberger anxiety questionnaires are completed by this group before and after the intervention. Coloring will be done only for the intervention group. How to paint and participate in the study is fully explained to the mothers by the researcher, (The coloring should be the same as the mandala patterns that have been determined in advance, and each part of the pattern should be colored with different colors, and the coloring should be orderly.) then the mothers in the intervention group are asked to start painting in a private and quiet place. Coloring three times a week and each time for at least 15 minutes.
Category
Other
2
Description
Control group: They do not receive this intervention during this period. Spiel Berger's anxiety questionnaire is completed again by mothers in both groups after the intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Mahbobeh Sajadi
Street address
Gerdoo St., Tandorosti Blvd., Arak city Town
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3278 2021
Email
golmehrsherafati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
DR Alireza Kamali
Street address
University complex of the Great prophet, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3493 4634
Email
golmehrsherafati@gmail.com
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
80
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
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great Prophet, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only the part of the data related to the original outcome will be able to be shared.
When the data will become available and for how long
Since the winter of 2023
To whom data/document is available
Researchers and students in this field
Under which criteria data/document could be used
In order to reduce the level of anxiety of the families of hospitalized patients
From where data/document is obtainable
Vice chancellor for education and research, Arak university of medical sciences
What processes are involved for a request to access data/document
These documents will be available on the website of Arak university of medical sciences.