The Effect of Mandala Therapy on Stress and Anxiety Among Mothers of Children Admitted to the Pediatric Intensive Care Unit
Design
A clinical trial with a control group, with parallel groups, without blinding, was conducted on 100 mothers with children hospitalized in the special care department of Afzalipur Hospital in Kerman. A table of random numbers was used for randomization
Settings and conduct
In two groups, Anxiety and stress of mothers are measured with Spielberger's State-Trait Anxiety Questionnaire and Cohen's Perceived Stress. If the score of anxiety and stress was moderate to severe, the samples will be placed in two groups of intervention and control in a simple random manner. In the mandala group, a mandala design is colored for 6 days and every day for 30 minutes. Then, the mother's anxiety and stress are checked on the sixth day after the end of the intervention, and in the control group, the mother's anxiety and stress are checked at the same time intervals.
Participants/Inclusion and exclusion criteria
Inclusion ctiteria: Willingness to participate in the study, Mothers of hospitalized children aged 1 to 12 years, Moderate to severe anxiety and stress before the intervention; Exclusion criteria: Mother's mental illness
Intervention groups
In the mandala group, several different designs of mandala painting and a pack of 6 colored pencils are provided to the mother. And she is asked to choose one of the designs every day for 6 days and paint it in 30 minutes. The control group will not receive any intervention and only the anxiety and stress of the mothers will be assessed at the same time interval as the intervention group.
Main outcome variables
Anxiety، stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220203053920N2
Registration date:2023-05-17, 1402/02/27
Registration timing:prospective
Last update:2023-05-17, 1402/02/27
Update count:0
Registration date
2023-05-17, 1402/02/27
Registrant information
Name
Reihane Moghimian Shahrbabaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 9438
Email address
moghimianreihane1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Mandala Art Therapy on Stress and Anxiety Among Mothers of Children Admitted to the Pediatric Intensive Care Unit (PICU)
Public title
The Effect of Mandala on Stress and Anxiety of Mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and written consent
Mothers of hospitalized children aged 1 to 12 years
The age range of the mother is 50-18
Mother's anxiety and stress before the study based on Spielberger scale and perceived stress scale should be moderate to high
Exclusion criteria:
History of mental illness in the mother
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples to intervention and control groups is done by a simple random method and through a random number table. In this way, the researcher touches one of the numbers from left to right and records the numbers and assigns them to different groups. Even numbers will be considered for the intervention group and odd numbers for the control group, and sampling will continue until the required sample size is completed in the research.
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
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Jahad Blvd, Ebn Sina Avenue, Somayeh Crossroads, Kerman
City
Kerman
Province
Kerman
Postal code
7613859610
Approval date
2023-04-10, 1402/01/21
Ethics committee reference number
IR.KMU.REC.1402.013
Health conditions studied
1
Description of health condition studied
Stress and Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety score based on Spielberger scale
Timepoint
Before and after the intervention
Method of measurement
Spielberger State–Trait Anxiety Inventory
2
Description
Stress score on Cohen's perceived stress scale
Timepoint
Before and after the intervention
Method of measurement
Cohen Perceived Stress Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the mandala coloring group, after measuring the mother's stress and anxiety, several different designs of mandala painting are provided to the mother separately on A4 paper and a pack of 6 colored pencils. And mothers are asked to paint the mandala for 30 minutes every day for up to six consecutive days. Determining the time of coloring will be done according to the required of mothers. Before the intervention and on the sixth day after the intervention, the anxiety and stress questionnaire will be completed again.
Category
Treatment - Other
2
Description
Control group: In the control group, there is no intervention and the mother's anxiety and stress is checked only at the same time intervals in the group of mandala coloring.