The effect of discharge plan implementation on knowledge of care and quality of life in mothers of children with congenital heart diseases undergoing surgery
The effect of discharge planning on knowledge of care and quality of life in mothers of children with congenital heart diseases undergoing surgery
Design
clinical trial with Control group
Settings and conduct
Intervention in this study is the implementation of the discharge plan that will be carried out in children with congenital heart disease undergoing surgery in Shahid Rajaee Heart Hospital of Tehran.The discharge plan includes education at admission, hospitalized days to the ward, during discharge and follow up after discharge that provided by the researcher to the mothers of children with congenital heart disease. According to the nature of the study, no blinding has been done.
Participants/Inclusion and exclusion criteria
Inclousion Criteria: Mother's understanding and mastery of Persian language
Mother's education is at reading and writing,The mother has not physical, psychological and cognitive disease,The child has undergone cardiac surgery for the first time,The length of the child's admission is more than 3 days.
Exclousion Criteria: Mother's education is in the medical field , The presence of another child with chronic illness in the family.
Intervention groups
The intervention group:The intervention involves education for 6 sessions of 30 minutes at admission, hospitalized days to the ward and during discharge to the mothers and follow up after discharge at 2 months .Individual education and small groups are conducted using an instruction booklet.The educational content includes: explanations of the structure of the normal and abnormal heart, physical activity, child nutrition , bathing , preventing infection, caring for surgical scar, benefits and side effects of drugs and the treatment of fever and diarrhea. The control group: Mothers in this group receive routine hospital care.
Main outcome variables
Knowleg of care ؛ Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180501039489N3
Registration date:2019-06-24, 1398/04/03
Registration timing:registered_while_recruiting
Last update:2019-06-24, 1398/04/03
Update count:0
Registration date
2019-06-24, 1398/04/03
Registrant information
Name
Fahimeh Sabeti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2885
Email address
sabeti.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-10, 1398/02/20
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of discharge plan implementation on knowledge of care and quality of life in mothers of children with congenital heart diseases undergoing surgery
Public title
The effect of discharge plan on knowledge and quality of life in mothers of children with congenital heart diseases
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mother's understanding and mastery of Persian language
Mother's education is at reading and writing
The mother has not physical, psychological and cognitive disease
The child has undergone cardiac surgery for the first time
The length of the child's admission is more than 3 days.
Exclusion criteria:
Mother's education is in the medical field
The presence of another child with chronic illness in the family
Age
From 1 day old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not 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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-04-07, 1398/01/18
Ethics committee reference number
IR.IUMS.REC.1398.217
Health conditions studied
1
Description of health condition studied
Congenital malformations of cardiac chambers and connections
ICD-10 code
Q20
ICD-10 code description
Congenital malformations of cardiac chambers and connections
2
Description of health condition studied
Congenital malformations of cardiac septa
ICD-10 code
Q21
ICD-10 code description
Congenital malformations of cardiac septa
3
Description of health condition studied
Congenital malformations of pulmonary and tricuspid valves
ICD-10 code
Q22
ICD-10 code description
Congenital malformations of pulmonary and tricuspid valves
4
Description of health condition studied
Congenital malformations of aortic and mitral valves
ICD-10 code
Q23
ICD-10 code description
Congenital malformations of aortic and mitral valves
Primary outcomes
1
Description
knowledge of care
Timepoint
Before intervention, Discharge time, 2 month after intervention
Method of measurement
Knowledge of care questionnair
2
Description
Quality of life
Timepoint
Before intervention ,2 month after intervention
Method of measurement
Quality of life questionnair
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group at first, Demographic questionnaire, knowlege of care and quality of life questionnaire were completed before the intervention by mothers. Then, in the first stage of intervention, the education includes 6 sessions of 30 minutes at admission, hospitalized days and discharge time individually and small groups using a booklet for mothers. The educational content includes: explanations of the natural and abnormal heart structure, surgical treatment, physical activity, child nutrition post-surgery, baby bathing, infection prevention, surgical scar treatment, medication usage, benefits and side effects of medications and Treatment of fever and diarrhea. The second stage of the intervention involves post discharge follow-up.At this stage, the researcher will call with the mothers, one week, two weeks, one month, and two months after the discharge , asking for the child's condition and, if necessary, giving them the necessary education.
Category
Rehabilitation
2
Description
Control group: this group completes the relevant questionnaires and receives only the usual care and training of the hospital.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Heart Hospital
Full name of responsible person
Masomeh Safarkhanlo
Street address
Shahid Rajaee Hospital, Next to Mellat Park,Valiasr Ave Tehran,IRAN
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
rhc@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Kazem Malekoti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran 1449614535, IRA
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
malakoutik@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Iran University of Medical Sciences
Full name of responsible person
Fahime Sabeti
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery School.Rashidyasemi St, Valiasr St,Tehran
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 214365
Email
sabetifa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fahime Sabeti
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery,Rashid Yasemi St.,Valiasr St.,IRAN Tehran
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 214365
Fax
+98 21 8820 1978
Email
sabetifa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fahimeh Sabeti
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
school of nursing &Midwifery,Rashid Yasemi Street,vanak Square,vali-e Asr Street
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 8888 2885
Email
Sabeti.f@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available