The effect of family-centered care on parental care burden and anxiety of children after heart transplantation
Design
Family-centered, in four stages of perceived threat, self-efficacy, educational participation and evaluation are performed in four sessions of 20 to 40 minutes for the intervention group; The control group receives only routine ward care .Randomization and blinding are not done
Settings and conduct
Research environment of Shahid Rajaei Hospital
Participants/Inclusion and exclusion criteria
Self-declaration of non-parental mental illness
Awareness of the type of child disease
- No stressful events other than the child's illness during the past year
- Not attending similar training sessions and classes
- Hospitalization and presence of the child for at least 5 days in the ward
Lack of care for another patient at home
Intervention groups
First, by obtaining the necessary permits, they were randomly selected into two experimental and control groups. 56 parents of children will be selected after heart transplantation. While the control group receives routine care, after completing the training, the anxiety and care questionnaires are distributed to the experimental and control groups and a month later. Finally, the data obtained from the questionnaires are collected and analyzed.
Main outcome variables
Education and application of family-centered care reduces the burden of care and anxiety of parents of children after heart transplantation
General information
Reason for update
Acronym
پیوند قلب
IRCT registration information
IRCT registration number:IRCT20141216020344N2
Registration date:2021-01-13, 1399/10/24
Registration timing:registered_while_recruiting
Last update:2021-01-13, 1399/10/24
Update count:0
Registration date
2021-01-13, 1399/10/24
Registrant information
Name
Hamidreza Khoshnezhad Ebrahimi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7787 2189
Email address
khoshnezhad.hr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-29, 1399/09/09
Expected recruitment end date
2021-08-28, 1400/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered care on the burden of care and anxiety in parents of children after heart transplantation
Public title
The effect of family-centered care on the burden of care and anxiety in parents of children after heart transplantation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of heart transplant children 7-15 years
Self-reported non-parental mental illness
Awareness of the type of child disease
No stressful events other than the child's illness during the past year
Absence from attending similar training sessions and classes-
Hospitalization and presence of the child for at least 5 days in the ward
Lack of care for another patient at home
Exclusion criteria:
Age
From 7 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-11-30, 1399/09/10
Ethics committee reference number
IR.IUMS.REC.1399.930
2
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-11-30, 1399/09/10
Ethics committee reference number
IR.IUMS.REC.1399.930
Health conditions studied
1
Description of health condition studied
Heart transplantation in children
ICD-10 code
i160-i169
ICD-10 code description
بیماری قلب عروقی
Primary outcomes
1
Description
burden of care
Timepoint
Before intervention and immediately after intervention and one month after intervention
Method of measurement
Zarit Care Questionnaire
2
Description
Anxiety
Timepoint
Before intervention and immediately after intervention and one month after intervention
Method of measurement
Beck Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Family-oriented, in four stages of perceived threat, self-efficacy, educational participation and evaluation are performed in four sessions of 20 to 40 minutes for the intervention group.
Category
N/A
2
Description
Control group: in the control group, routine care is performed and family-centered interventions are not performed
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Heart Hospital, Tehran
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
Street address
Tehran - Vali Asr St. (AS) - next to Mellat Park - corner of Niayesh Shahid Rajaei Cardiovascular Training, Research and Treatment Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
khoshnezhad.hr@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abbas Motavlian
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
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
Dr Hamidreza Khoshnezhad Ebrahimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.acir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
19198167766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.acir
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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data is encrypted in order to make the identities of individuals unidentifiable and confidential
When the data will become available and for how long
From the end of sampling to 6 months after the publication of the article
To whom data/document is available
University Ethics Committee, Project Arbitration Committee, Article Arbitration Committee and other researchers
Under which criteria data/document could be used
Perform systematic review or meta-analysis by mentioning the document
From where data/document is obtainable
Dr Hamidreza Khoshnezhad Ebrahimi
What processes are involved for a request to access data/document
After submitting the application via academic email, we will provide information files to individuals within a maximum of one week