(1) Objective:The effect of emotional intelligence component training in mothers on quality of life in their 2- 6 years old children with congenital heart disease .(2) Design:not blind clinical trial study .(3) Setting and conduct:his is population consisted of mothers of children with Congenital heart disease is2-6years. 120 person for random sampling IS select and placed in two groups of 60 person and state in experimental and control groups.
Before the start of training, quality of life questionnaires 2-6 years children with congenital heart disease of the mothers mind and Emotional Intelligence Bar-on Questionnaire for mothers and mother and children demographic information will be complet by the mothers in both groups. Then Education group will be receive, of emotional intelligence components for 90 minute section five over five weeks .
But control group did not receive this training .then at the end of the last section and one month after intervention, both groups were given questionnaires for to complete. the control group receives education materials in the form of booklet after intervention .(4) Inclusion criteria: Children 6-2 years with congenital heart abnormality that by Shiraz University of Medical Sciences cardiologist confirme؛the mother be primary caregiver؛ maternal age be 35-18 years ؛the minimum education level of mothers be diploma.(5) Exclusion criteria:death of the child or mother during the study؛ Mothers cut continue working on this research
.(6) interventions: education by training interactive multimedia and educational booklet. (7) main outcome measures: changes in level of quality of life in their 2- 6 years old children with congenital heart disease .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016083029601N1
Registration date:2016-10-26, 1395/08/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-26, 1395/08/05
Registrant information
Name
Somayee Zare
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4333 1538
Email address
stud2431409181@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2016-10-31, 1395/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of emotional intelligence component training in mothers on quality of life in their 2- 6 years old children with congenital heart disease
Public title
Effect of emotional intelligence component training on quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria؛ Children 6-2 years with congenital heart abnormality that by Shiraz University of Medical Sciences cardiologist confirme؛the mother be primary caregiver؛ maternal age be 35-18 years ؛the minimum education level of mothers be diploma ؛ Exclusion criteria؛ death of the child or mother during the study؛ Mothers cut continue working on this research
Age
From 1 year old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Ethics Committee, seventh floor, Shiraz University of Medical Sciences, next to the Red Crescent headquarters, Zand Ave., Shiraz.
City
Shiraz
Postal code
71348-14336
Approval date
2016-05-29, 1395/03/09
Ethics committee reference number
ir.sums.rec.1395.33
Health conditions studied
1
Description of health condition studied
Congenital malformations of cardiac septa
ICD-10 code
Q21
ICD-10 code description
Congenital malformations of cardiac septa
Primary outcomes
1
Description
quality of life
Timepoint
Before the intervention, Immediately after the intervention and one month later
Method of measurement
Questionaire
Secondary outcomes
1
Description
Emotional Intelligence
Timepoint
Before the intervention, after intervention and one month later
Method of measurement
Bar- on Emotional Intelligence questionnaire
Intervention groups
1
Description
The members of the intervention group had workshop for 5 section 90 minute duration 5 weeks. Also they completed Bar- on emotional ،ped quality of life questionnaires before, immediately after, and one month after the intervention.
Category
Other
2
Description
The members of the control group completed Bar- on emotional intelligence,ped quality of life questionnaires before,after, and one month later, withouth any intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital affliated to Shiraz University of Medical Sciences
Full name of responsible person
Zohre Montaseri
Street address
Namazi Square, Zand street Shiraz
City
Shiraz
2
Recruitment center
Name of recruitment center
Faghihi Shahidi Hospital affliated to Shiraz University of Medical Sciences
Full name of responsible person
Zohre Montaseri
Street address
Namazi Square, Zand street Shiraz
City
Shiraz
3
Recruitment center
Name of recruitment center
Emam reza Clinicl affliated to Shiraz University of Medical Sciences
Full name of responsible person
Zohre Montaseri
Street address
Namazi Square, Zand street Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Science, Vice chancellor for research
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Vice chancellor for research, seventh floor, Shiraz University of Medical Science, next to the Red Crescent headquarters, Zand Ave., Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Science, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
hiraz University of Medical Science,Shiraz Hazrate Fatemeh Nursing and Midwifery college
Full name of responsible person
Zohre Montaseri
Position
Master Of Nursing
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz.
City
shiraz
Postal code
13119–71936
Phone
+98 71 3647 4257
Fax
+98 71 3647 4252
Email
montaseriz@sums.ac.ir
Web page address
nurs-midwif.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science, Shiraz Hazrate Fatemeh Nursing and Midwifery college
Full name of responsible person
Montaseri Zohre
Position
Master Of Nursing
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz.
City
Shiraz
Postal code
71936 -13119
Phone
+98 71 3647 4257
Fax
+98 71 3647 4252
Email
montaseriz@sums.ac.ir
Web page address
nurs-midwif.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science,Shiraz Hazrate Fatemeh Nursing and Midwifery college
Full name of responsible person
Somayee Zare
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
Fax
Email
Z91SOMAYEA@YAHOO.COM
montaseriz@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)