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The Effect of Home Care Educational Application on the Perceived Stress and Caregiving Burden in Parents of Children Undergoing Surgery for Congenital Heart Disease

Protocol summary

Study aim
To Determine the Effect of Home Care Educational Application on the Perceived Stress and Care Burden of Parents of Children Undergoing Surgery for Congenital Heart Disease.
Design
Phase III Randomized Clinical Trial with Two Groups, Pre-test and Post-test, without Blinding, 72 People Randomly Assigned Through PASS 11 Software
Settings and conduct
The location of the study is open heart surgery department in Imam Reza Hospital in Mashhad. The content of the educational application will be prepared based on the review of the texts and the opinion of experts. Before the intervention, the questionnaire of personal characteristics, the perceived stress questionnaire of Cohen and the care burden questionnaire of Zarit are completed in person by both groups. The intervention will last for a period of one month. Then, one month later, the questionnaires will be completed again in both groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Parents of Children with Congenital Heart Disease who have the Desire to Participate in Research and the Ability to use a Smartphone. Exclusion criteria: Parents' unwillingness, Child's death.
Intervention groups
In the intervention group, the home care educational application will be installed on the parents' mobile phones and how to use it will be taught. Offline parents can access the content of the application, which includes general information about the child's illness, complications of surgery and post-discharge care, necessary skills to reduce stress and other necessary measures, mostly written, audio, video and photo, for a month. achieve The control group will receive training using pamphlets that are explained face-to-face by the researcher.
Main outcome variables
Perceived Stress; caregiving burden

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231001059583N1
Registration date: 2023-10-11, 1402/07/19
Registration timing: prospective

Last update: 2023-10-11, 1402/07/19
Update count: 0
Registration date
2023-10-11, 1402/07/19
Registrant information
Name
Somaye Ostadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3724 3007
Email address
ostadis971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-11, 1402/08/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Home Care Educational Application on the Perceived Stress and Caregiving Burden in Parents of Children Undergoing Surgery for Congenital Heart Disease
Public title
Investigating the effect of home care educational application on perceived stress and care burden of parents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Parents of children with congenital heart disease from one month to 11 years who undergo heart surgery for the first time Willingness to participate in research Ability to use a smartphone Not having a psychological problem and not taking psychoactive drugs There is no other child with this disease or any other chronic disease in the family that needs care
Exclusion criteria:
Parents' unwillingness to continue participating in the research The need for intervention or emergency operation again during research Death of a child during research Occurrence of severe stressful events during study for the family
Age
From 1 month old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done in such a way that people will be divided into two groups through the PASS 11 software using blocks of four. In this way, after determining the sequence, we put them in the envelopes and number them in order. One of the parents will take the envelope in the order of their entry into the study and will be placed in the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The content of the application includes: training in the field of post-operative care at home, which includes information about the child's illness, post-operative care, including wound and operation site care, introduction of drugs, how to take and side effects of drugs, proper nutrition and the appropriate amount of activity for the child. With the age of the child (one month to one year old, 1 to 3 years old, 3 to 5 years old, 5 to 11 years old), the symptoms will need to see a doctor, follow up treatment, in addition, regarding the methods of dealing with stress, including: information about the sources of stress , training in deep breathing skills, listening to music, communicating with others to help reduce stress, as well as self-care as a caregiver (adequate sleep and rest, exercise and proper nutrition) will be provided. The mentioned content will be prepared based on the review of the texts and experts' opinions, then the educational application, which is an offline, Android, non-interactive and multimedia-based application, will be designed and piloted to the experts and children's parents, and their corrective comments will be applied. became.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Nursing and Midwifery - Mashhad University of Medical Sciences
Street address
Educational Complex of Shahid Dr. Kharazmi, University Campus, east gate of Ferdowsi University of Mashhad, Azadi Square, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-08-15, 1402/05/24
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.078

Health conditions studied

1

Description of health condition studied
Children undergoing surgery for congenital heart disease
ICD-10 code
Q20
ICD-10 code description
Congenital malformations of cardiac chambers and connections

Primary outcomes

1

Description
Perceived Stress
Timepoint
Measuring perceived stress at the beginning of the study (before the start of the intervention) and one month after using the educational application
Method of measurement
Cohen's Perceived Stress Questionnaire

2

Description
Caregiving Burden
Timepoint
Caregiving burden measurement at the beginning of the study (before the intervention) and one month after using the educational application
Method of measurement
Zarit Care Burden Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, one day before the child's discharge in the open heart surgery department, the home care educational application will be installed on the smartphone of the parents or a family member and will be taught how to use it.
Category
Prevention

2

Description
Control group: The control group will receive routine training, which currently involves the use of a training pamphlet that is explained face-to-face by the researcher.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital, open heart surgery department
Full name of responsible person
Zahra Dalir
Street address
Imam Reza Educational Research and Treatment Center, Imam Reza Hospital Square, Ibn Sina Ave, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
dalirz@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research and Technology Vice-Chancellor of Mashhad University of Medical Sciences, Second Floor, Qureshi Building, Front of 16 University Ave, University Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Dalir
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Educational Complex of Shahid Dr. Kharazmi, University Campus, east gate of Ferdowsi University of Mashhad, Azadi Square, Mashhad, Khorasan Razavi
City
Mashahd
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
dalirz@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Somaye Ostadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
6 Esfraini Ave
City
Esfarayen
Province
North Khorasan
Postal code
9661764488
Phone
+98 58 3724 3007
Fax
Email
Ostadis971@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Somaye Ostadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
6 Esfraini Ave
City
Esfarayen
Province
North Khorasan
Postal code
9661764488
Phone
+98 58 3724 3007
Fax
Email
Ostadis971@mums.ac.ir

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
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
All the data obtained from this research will be shared after completion.
When the data will become available and for how long
Access to the data will be possible 3 months after the results are published.
To whom data/document is available
These data will be used for researchers working in academic and scientific institutions, as well as for parents with children with congenital heart disease.
Under which criteria data/document could be used
The data obtained from this research can be used in other scientific studies.
From where data/document is obtainable
Copying (in any way) either from the full text or from the extracts is possible only with the coordination of the supervisor and the registered author and according to the instructions provided by the Central Library of Mashhad University of Medical Sciences. Details can be accessed through the relevant faculty library. The use of the thesis in articles or any scientific writing is subject to citing the source in compliance with the Mashhad University of Medical Sciences publishing regulations. Somaye Ostadi OstadiS971@mums.ac.ir
What processes are involved for a request to access data/document
The applicant should send an email to the responsible author and register his request. After verifying the correctness of the information of the mentioned person, the required content will be provided to him by mentioning the source.
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