The comparison of the quality of life and self-efficacy of the mothers of infant with congenital heart disease in two educational program and control groups.
This study aimed to assess the effect of an educational program on the quality of life and self efficacy of mothers of infants with congenital heart disease. The present clinical trial study was conducted on 60 mothers (30 in the control and 30 in the intervention group) referring to Emam Reza affiliated to Shiraz University of Medical Sciences. The inclusion criteria were the infants suffering from Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD), and Patent Ductus Arteriosus (PDA). Moreover, the children did not have other chronic diseases. The exclusion criteria of the study were the infants hospitalization during the intervention period. The intervention group received the educational program through four 90 - minute sessions in 4 weeks and the control group received routine care. The mothers’ quality of life and self efficacy were assessed using SF-36 and Sherer general self efficacy questionnaire before, immediately and 2 months after the training.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012080410489N1
Registration date:2013-10-09, 1392/07/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-09, 1392/07/17
Registrant information
Name
Mozhgan Kamali
Name of organization / entity
Shiraz University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 917 562 8900
Email address
kamalimo@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2012-07-31, 1391/05/10
Expected recruitment end date
2012-10-31, 1391/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the quality of life and self-efficacy of the mothers of infant with congenital heart disease in two educational program and control groups.
Public title
Effect of an education program on congenital heart disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:1. The children suffering from ASD, VSD, PDA 2. The children not suffering from other chronic diseases
3. Being less than 12 months
4. The family having no other children with congenital heart disease
5. The children not having under gone heart surgery.
Exclusion criteria:
1. The children death
2. Unwillingness to cooperate in the study
3. The children hospitalization during the intervention
Age
No age limit
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
60
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, Shiraz, Iran
Street address
Shiraz University Of Medical Sciences, Zand Ave. , Shiraz, Iran
Before intervention, immediately after, and 2 months after the last educational session
Method of measurement
SF_36 Questionnaire
2
Description
Self - efficacy
Timepoint
Before intervention, immediately after, and 2 months after the last educational session
Method of measurement
Sherer General Self Efficacy questionnaire
Secondary outcomes
1
Description
Mental Health
Timepoint
Before intervention, immediately and 2 months after last training session
Method of measurement
GHQ-28 Questionnaire
Intervention groups
1
Description
The experimental group were received the educational program through four 90 – minute sessions in 4 weeks. This program was presented through power point and included information about the disease, type of disease, causes, symptoms, diagnostics tests, treatment, its effect on the infant and family, coping methods, taking care of such infants at home, nutrition, preventing infection, vaccination, and medication.