بررسی تاثیرمراقبت خانواده محور بر خودکارامدی و امید والدین کودکان مبتلا به سرطان
Design
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; The control group receives only routine ward care
Settings and conduct
Research environment of Hazrat Ali Asghar Hospital
Participants/Inclusion and exclusion criteria
Self-declaration of non-parental mental illness
Knowledge of the type of child disease
No stressful event 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
Intervention groups
First, by obtaining the necessary permits, they are randomly selected into experimental and control groups. A total of 64 parents of children with cancer are selected. The control group receives routine care, and after completing the training, self-efficacy and hope questionnaires are distributed to the experimental and control groups and distributed one month later. Finally, the data obtained from the questionnaires are collected and analyzed
Main outcome variables
Self-efficacy and hope
General information
Reason for update
Acronym
سرطان
IRCT registration information
IRCT registration number:IRCT20141216020344N3
Registration date:2021-03-07, 1399/12/17
Registration timing:prospective
Last update:2021-03-07, 1399/12/17
Update count:0
Registration date
2021-03-07, 1399/12/17
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
2021-03-21, 1400/01/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of family-centered are on the self-efficacy and hope of parents of children with cancer
Public title
the effect of family-centered are on the self-efficacy and hope of parents of children with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Parents of children 6 to 12 years old with cancer
Self-declaration of non-parental mental illness
Knowledge of the type of child disease
No stressful event other than the child's illness during the past year
Absence from attending similar training sessions and classes - hospitalization
Hospitalization and presence of the child for at least 5 days in the ward
Lack of care for another patient at home
Exclusion criteria:
Lack of parental cooperation
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.IUMS.REC.1399.994
Health conditions studied
1
Description of health condition studied
Cancer in children
ICD-10 code
C80.1
ICD-10 code description
Malignant (primary) neoplasm, unspecified
Primary outcomes
1
Description
self-efficacy
Timepoint
Before intervention and immediately after intervention and one month after intervention
Method of measurement
Scherer General Self-Efficacy Questionnaire
2
Description
hope
Timepoint
Before intervention and immediately after intervention and one month after intervention
Method of measurement
Schneider Life expectancy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The family-centered model is implemented in four stages of perceived threat, self-efficacy, educational participation and evaluation during four sessions of 20 to 40 minutes for the intervention group. Based on this model, the first step in the intervention stage is threat perception, which increases parental knowledge and awareness. This is done through education about the disease, its complications, ways of prevention, ways of transfer and consumption of drugs, morale and follow-up of tests and treatment. The second step is the problem-solving stage, which is done to increase self-esteem and self-control. At this stage, when parents' knowledge and attitudes about the disease should be increased, they should be included in care programs. The third step is educational participation. The fourth step is evaluation, which is measured in two stages, one at the end of the intervention and one month later. Complete the relevant questionnaire. Then four 40-minute sessions are performed in four consecutive weeks (one session per week, every day). Before each session with the parents, the meeting time is set and the sessions are held for their convenience in the study class of the department. In the first session (40 minutes), the researcher uses face-to-face training with parents about childhood cancer, common signs and symptoms, and diagnostic techniques. And treatment plans, depending on the stage and condition of the child's illness; These parents are then given basic training in this area. It should be noted that this session is presented separately to all parents in the intervention group. The second session is 40 minutes long, they are asked to talk about ways of communication. And exchange views with the hospital treatment team. In this session, they share their experiences and information about treatment, evaluation and control of treatment side effects. Other topics discussed in this session include ways to prevent infection, control and relieve pain, side effects of medications, improve self-control in the face of sick children and their problems, as well as ways to support other family members. During this session, the researcher tries to indirectly lead the discussion and guide the group towards enriching self-efficacy. During the third session, and in order to implement the third phase of the empowerment model, each participant is asked to teach one of their family members, who is responsible for child care, about what they have learned in the previous two sessions. , And answer the researcher's questions under his / her indirect supervision. During this session, any possible problems, such as forgetting the material or passing on incorrect information by the trained parents, will be corrected immediately by the researcher. In the fourth session or the final evaluation session, the researcher evaluates all the questions of the participants in the intervention group by asking questions about the total content taught and the items that were discussed in the second and third sessions. It finally clears up the remaining ambiguities.
Category
N/A
2
Description
Control group: 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
Hazrat Ali Asghar Hospital in Tehran
Full name of responsible person
Dr. Shabahang Jafarnejad
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
Jafarnejad.sh@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. Shabahang Jafarnejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatric 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
Jafarnejad.sh@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
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatric 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 updating data
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
Pediatric 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
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
Yes - There is a plan to make this available
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
En 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