Protocol summary

Study aim
Investigating the impact of continuous care on resilience and caregiving burden of mothers of children with heart abnormalities
Design
In this study, which is conducted at the Children's Medical Center Hospital, one of the centers covered by Tehran University of Medical Sciences, the intervention group and the control group include mothers who have children with congenital anomalies of non-cyanotic disease asd.vsd.pda.coa. The intervention group consisted of 40 people. . and there are 40 people in the control group. According to random cluster sampling, the control or intervention group is continuously selected for one week, and explanations and introductions are provided, and consent is obtained from them, and questionnaires on demographic characteristics, care burden, Zarit and Uri Kandividson are done for them. to be Then, with an interval of three days, randomization may be done again. In the control group, regular training is provided, and in the intervention group, the continuous care model includes familiarization and sensitization, and control and evaluation. Face-to-face and control within a period of 9 weeks, if possible, face-to-face or by phone through messengers or telephone conversations, and evaluation within a period of 2 weeks will include completing the questionnaires again. After 8 weeks from the completion of the intervention, the questionnaires will be completed.
Settings and conduct
Sampling includes 40 intervention people and 40 control people who are in the open heart surgery special care departments of Children's Medical Center
Participants/Inclusion and exclusion criteria
literate Don't participate in a similar study
Intervention groups
The intervention group and the control group are mothers of children who have children with congenital heart abnormalities (non-cyanotic type including asd.vsd.pda.coa).
Main outcome variables
Resilience;care burden

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240205060908N1
Registration date: 2024-06-08, 1403/03/19
Registration timing: registered_while_recruiting

Last update: 2024-06-08, 1403/03/19
Update count: 0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Negar ShamsKondori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 602 8237
Email address
negarshams1375@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-14, 1402/11/25
Expected recruitment end date
2024-08-15, 1403/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of continuous care on the care burden and resilience of mothers of children with congenital heart defects
Public title
Investigating the effect of continuous care on the care burden and resilience of mothers of children with congenital heart defects
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
having minimum reading and writing literacy, the ability to make phone calls and the ability to use one of the messaging applications, not suffering from cognitive and psychological disorders known by self-report, mothers not participating in similar studies
Exclusion criteria:
Age
No age limit
Gender
Female
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
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Koy Tehran university of medical sciences, Amir abad Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
1439955975
Approval date
2024-02-01, 1402/11/12
Ethics committee reference number
IR.TUMS.CHMC.REC.1402.155

Health conditions studied

1

Description of health condition studied
burden of care
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Resilience
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Increasing the score of Zarit's care burden questionnaire and Conner-Davidson's resilience compared to before the intervention
Timepoint
At the beginning of the intervention and then at the end of the study and eight weeks after the end of the intervention
Method of measurement
Using Zarit's Care Burden and Conner-Davidson's Resilience Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: mohters of children with congenital heart diseases
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Children medical center hospital
Full name of responsible person
Negar Shams kondori
Street address
Docter gharib Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۵۱
Phone
+98 21 6693 0024
Email
Negarshams1375@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Negarshamskondori
Street address
No. 16., Kargarshomali. Tehran Town
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۷۱۱۸
Phone
+98 51 5523 4287
Email
Negarshams1375@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Negar Shams Kondori
Position
Master Student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Koy Tehran University of Medical Sciences,Amir abad Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 919 602 8237
Email
negarshams1375@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Negar Shams Kondori
Position
Collegian
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 16, Kargar Shomali Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۷۱۱۸
Phone
+98 51 5523 4287
Email
Negarshams1375@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
NegarShamsKondori
Position
Collegian
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 16, Kargar Shomali., Tehran Town
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۷۱۱۸
Phone
+98 51 5523 4287
Email
Negarshams1375@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After the final review, a decision will be made and implemented with the opinion of the respected instructor
When the data will become available and for how long
After the final review, a decision will be made and implemented with the opinion of the respected instructor
To whom data/document is available
After the final review, a decision will be made and implemented with the opinion of the respected instructor
Under which criteria data/document could be used
After the final review, a decision will be made and implemented with the opinion of the respected instructor
From where data/document is obtainable
After the final review, a decision will be made and implemented with the opinion of the respected instructor
What processes are involved for a request to access data/document
After the final review, a decision will be made and implemented with the opinion of the respected instructor
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