Determining the effect of mandala coloring on the level of anxiety after surgery of mothers of children undergoing surgery for congenital anomalies
Design
Randomized controlled clinical trial study on 96 mothers. Two intervention groups (coloring group) and control group (non coloring group). The method of randomization is based on the case number, Intervention group (even number) and control group (odd number).
Settings and conduct
Mothers of children candidates for congenital anomaly surgery who are available in Mofid Hospital during the sampling will be included based on inclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria of mothers
At least 18 years old
Has a 0 to 7 year old child Candidate for congenital anomaly surgery
The child's biological mother
Living with the child and husband (child's father)
Not suffering from mental health problems
Exclusion criteria
Leaving the research community (change of hospitalization, death)
Change in the child's consciousness
Intervention groups
The Spielberger Anxiety Inventory (STAI) will be administer after surgery among both groups. Subsequently,Intervention group will be receive performed mandala coloring for 30 min/day for three consecutive days after surgery. In 3th day of the intervention, the STAI questionnaire will be administer to mothers in both groups.
Main outcome variables
Anxiety score before and after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240311061262N1
Registration date:2024-03-18, 1402/12/28
Registration timing:prospective
Last update:2024-03-18, 1402/12/28
Update count:0
Registration date
2024-03-18, 1402/12/28
Registrant information
Name
Zahra Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3523 1365
Email address
zahraghorbani178@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effectiveness of Mandala Coloring on Anxiety Level After Surgery of Mothers with Children Undergoing Surgery for Congenital Abnormality
Public title
Evaluating the Effectiveness of Mandala Coloring on Anxiety Level After Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All mothers of children aged 0-7 with definite diagnosis of congenital Abnormality
Exclusion criteria:
Mothers whose baby is expected to need intensive care unit admission after surgery will not be included in the study.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The mothers under the study will be randomly divided into intervention (mandala coloring) and control (no coloring) groups, and the anxiety level before and after the intervention group and the anxiety level of the two groups will be compared.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of School of Pharmacy and Nursing&Midwifery-Shahid Beheshti University of Medical
Street address
Faculty of Nursing and Midwifery., Ayat Ah... Hashemi Rafsanjani Highway., Vali Asr Street
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.318
Health conditions studied
1
Description of health condition studied
Congenital Abnormality
ICD-10 code
Q35
ICD-10 code description
Cleft palate
2
Description of health condition studied
Congenital Abnormality
ICD-10 code
Q36
ICD-10 code description
Cleft lip
3
Description of health condition studied
Congenital Abnormality
ICD-10 code
Q37
ICD-10 code description
Cleft palate with cleft lip
4
Description of health condition studied
Congenital Abnormality
ICD-10 code
Q38
ICD-10 code description
Other congenital malformations of tongue, mouth and pharynx
5
Description of health condition studied
Congenital Abnormality
ICD-10 code
Q39
ICD-10 code description
Congenital malformations of esophagus
6
Description of health condition studied
Congenital Abnormality
ICD-10 code
Q41
ICD-10 code description
Congenital absence, atresia and stenosis of small intestine
7
Description of health condition studied
Congenital Abnormality
ICD-10 code
Q42
ICD-10 code description
Congenital absence, atresia and stenosis of large intestine
8
Description of health condition studied
Congenital Abnormality
ICD-10 code
Q43
ICD-10 code description
Other congenital malformations of intestine
9
Description of health condition studied
Congenital Abnormality
ICD-10 code
Q44
ICD-10 code description
Congenital malformations of gallbladder, bile ducts and liver
10
Description of health condition studied
Congenital Abnormality
ICD-10 code
Q61
ICD-10 code description
Cystic kidney disease
11
Description of health condition studied
Congenital Abnormality
ICD-10 code
Q62.7
ICD-10 code description
Congenital vesico-uretero-renal reflux
12
Description of health condition studied
Congenital Abnormality
ICD-10 code
Q64.0
ICD-10 code description
Epispadias
13
Description of health condition studied
Congenital Abnormality
ICD-10 code
Q54
ICD-10 code description
Hypospadias
Primary outcomes
1
Description
Anxiety score in Spielberger's State-Trait Anxiety Inventory
Timepoint
The beginning of the study (before the start of the intervention and after surgery ) and the third day after surgery and intervention
Method of measurement
Spielberger's State-Trait Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will complete the Spielberger Anxiety Inventory (STAI) after the surgery and the child's hospitalization in the surgery department, and then the per-designed mandala drawings on A4 sheets and coloring tools will be provided to the mothers of the intervention group in the period of 30 Minutes will be placed on the first, second, and third days after surgery. The intervention group will complete the Spielberger Anxiety Inventory (STAI) again on the third day after the intervention.
Category
Other
2
Description
Control group: The Spielberger Anxiety Inventory (STAI) will be completed after the surgery and the child's hospitalization in the surgery department, and this group will be divided into the group without coloring and will not receive the mandala coloring intervention, and on the third day, after the surgery, the list will be completed again. They will complete the Spielberger Anxiety Inventory (STAI).