A Comparative Study on the Effect of two Methods of Preoperational preparation; Hospital Tours and Oral Presentation, on the Anxiety of Mothers before Open Heart Surgery for Children with Congenital Heart Disease
Determining and comparing the effect of preoperative preparation on oral presentation and hospital tour on the anxiety of mothers before the open heart surgery of a child with congenital heart disease hospitalized in pediatric cardiac ward of Shahid Modarres Hospital in Tehran
Design
Clinical trial, one-blind, randomized control group
Settings and conduct
Research environment is Children's Heart Department of Shahid Modares Hospital. Mothers with children aged 1 to 3 years with a diagnosis of congenital heart disease candidates for open heart surgery are selected using available sampling method. mothers were randomly assigned to each group: Oral Preparation, Hospital Tour Preparation, and Standard preparation group, sampling in each group takes place within a week to prevent the association of mothers in the three groups.
Participants/Inclusion and exclusion criteria
Have reading and writing skills and ability to speak Persian, Mother's age is 20 to 50 years old
Exit criteria: Cancel surgery, Child's death, Exacerbation of the child's disease, Mother's departure
Intervention groups
In the oral explanation group, between 8:00 (Am) and 10:00 (Am) at morning and between 4-6 evenings in the afternoon session, the mothers participated in oral explanation sessions for 30 to 45 minutes. In the hospital tour group, two 30-45 minute rotations in the morning and evening to the operating room and the ICU section are carried out by a researcher with the participating mothers and the same explanations are given. In the Standard group, mothers do not receive any training by the researcher
Main outcome variables
Helping mothers of children born with congenital heart disease to reduce their anxiety during Open Heart surgery of their children is the result of this research.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190130042557N1
Registration date:2019-04-17, 1398/01/28
Registration timing:registered_while_recruiting
Last update:2019-04-17, 1398/01/28
Update count:0
Registration date
2019-04-17, 1398/01/28
Registrant information
Name
Asal Amintojari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2676 3815
Email address
a.amintojari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study on the Effect of two Methods of Preoperational preparation; Hospital Tours and Oral Presentation, on the Anxiety of Mothers before Open Heart Surgery for Children with Congenital Heart Disease
Public title
Comparison of the Effect of Oral Presentation and Hospital Tour on Mothers' Anxiety before the Children's Open Heart Surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All mothers of children with congenital heart disease who are admitted to open heart surgery
The mother is fluent in reading and writing and speaking in Persian
The mother is not afflicted with mental and anxiety disorders
Mother does not have a child with a history of heart surgery
Mother has no education in medical sciences and psychology
Mother is married
Mother has a biological relationship with the child
Exclusion criteria:
A child is at the age of infancy, young child, or school age.
Mother is illiterate.
The mother has anxiety or mental disorders.
Single mother
The child is admitted to the pediatric department of the Modares Hospital for angiography.
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The Mothers are selected using the available sampling method(In each three-week round, it is determined by simple drawings, which groups of participants in each week are placed in each of the three groups, and in order to prevent the association of mothers, sampling in each group takes place within a week) and gradually and in a simple randomized manner, they are placed in three groups: Oral presentation preparation, Hospital tour preparation and Standardized preparation.Sampling continues continuously until the required sample size is completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blind study and participants are unaware of the allocation of study groups. After obtaining informed consent from Mothers, in each three-week period, it is determined by a simple draw that each participant in each of the three study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti Faculty of Nursing and Midwif,Valiasr Intersectionery, Niyayesh Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2016-05-01, 1395/02/12
Ethics committee reference number
IR.SBMU.PHNM.1395.683
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
Mother anxiety in the Spielberg and Amsterdam questionnaires
Timepoint
Determine the anxiety level of the day before surgery (before intervention) and one hour before surgery (after surgery)
Method of measurement
In the study "Comparative study of the effect of preoperative preparation in two ways; Hospital tour and oral explanation on the anxiety of mothers before open heart surgery for children with congenital heart disease", the variable measurement method can be "Amsterdam Preoperative Anxiety and Information Scale" And the " spielberger state trait anxiety inventory" questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention group: Mothers receive oral information in two sessions in the morning and evening of preoperative preparation.
Category
Behavior
2
Description
Intervention group: Second intervention group: Mothers receive Hospital Tour preparation information in two sessions in the morning and evening.
Category
Behavior
3
Description
Control group: This group does not receive any interventions by the researcher and only receive routine care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Asal Amin Altojari
Street address
Kaj Square, Saadat Abad Street
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4101
Email
modarres@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Manizhe Nouriyan
Street address
Modarres Hospital, Kaj Square, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
a.amintojar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Asal Amin Altojari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kaj Square, Saadat Abad Street
City
Tehran
Province
Tehran
Postal code
19987344383
Phone
+98 21 2207 4087
Email
a.amintojar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Asal Amin Altojari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kaj Square, Saadat Abad Street
City
Tehran
Province
Tehran
Postal code
19987344383
Phone
+98 21 2207 4087
Email
a.amintojar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Asal Amin Altojari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kaj Square, Saadat Abad Street
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
a.amintojari@sbmu.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about participants is shared without their identification.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers and people working at the clinic and hospital
Under which criteria data/document could be used
Information is available to individuals when using research results in a hospital and implementing research methods.
From where data/document is obtainable
Email a.amintojar@gmail.com to receive the data.
What processes are involved for a request to access data/document
After receiving the email from the person requesting the information, information is sent after 1 to 2 weeks.