The effect of family-centered education on anxiety and stress of parents with a child with diabetes
Design
Clinical trial with control and intervention group on 100 people
Settings and conduct
Research environment of nephrology ward of Hazrat Ali Asghar Hospital
Participants/Inclusion and exclusion criteria
Admission requirements:
Parents of children 6 to 15 years old with diabetes
Knowledge of the type of child disease
Absence of any stressful event other than the child's illness during the past year
Absence from attending similar training sessions and classes
No entry conditions:
Lack of parental cooperation
Intervention groups
First, by obtaining the necessary permits, the experimental and control groups are randomly selected. A number of 100 parents of children with diabetes are selected. While the control group receives routine care, after the training, the anxiety and stress questionnaires are distributed to the experimental and control groups and one month later. Finally, the data obtained from the questionnaires are collected and analyzed
Main outcome variables
Anxiety and stress
General information
Reason for update
Acronym
دیابت
IRCT registration information
IRCT registration number:IRCT20141216020344N8
Registration date:2022-02-22, 1400/12/03
Registration timing:prospective
Last update:2022-02-22, 1400/12/03
Update count:0
Registration date
2022-02-22, 1400/12/03
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
2022-04-09, 1401/01/20
Expected recruitment end date
2022-10-12, 1401/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered education on anxiety and stress of parents with a child with diabetes
Public title
The effect of family-centered education on anxiety and stress of parents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Parents of children 6 to 15 years old with diabetes
Awareness of the type of child's disease
No stressful event other than the child's illness during the past year
Absence from attending similar training sessions and classes
Exclusion criteria:
Lack of parental cooperation
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
2022-01-26, 1400/11/06
Ethics committee reference number
IR.IUMS.REC.1400.1020
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention and immediately after intervention and one month after intervention
Method of measurement
Beck Anxiety Questionnaire
Secondary outcomes
1
Description
Stress
Timepoint
Before intervention and immediately after intervention and one month after intervention
Method of measurement
Life Stress Questionnaire (LDI)
Intervention groups
1
Description
Intervention group: 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; The control group receives only routine ward care. According to this model, the first step in the intervention phase is to understand the threat, which in this phase increases the knowledge and awareness of the parents. The use of drugs and the spirit and follow-up of tests and treatment is done. The second step is the problem-solving stage, which is done to increase self-esteem and self-control. In this stage, when parents' knowledge and attitude about the disease increase, they should participate 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. Parents are first asked to complete the parent 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 ward study class. In the first session (40 minutes), the researcher uses face-to-face training with parents about childhood diabetes, common signs and symptoms, diagnostic methods. And treatment programs, depending on the stage and condition of the child's illness; Then, these parents are given basic training in this field. It should be noted that this session is provided separately and to all parents in the intervention group. To implement the second stage of the empowerment model, parents are placed in groups of 6 to 3 people. Second, 40 minutes, they are asked to discuss ways to communicate and exchange ideas 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 proper nutrition, hygiene and how to inject insulin, side effects of medications, improving 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 lead the discussion indirectly. During the third session, and in order to implement the third stage of the empowerment model, each participant is asked to go to one of his / her family members, who is responsible for caring for the child. , To teach about what they have learned in the last 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 whole content taught and the items that were discussed in the second and third sessions. Eventually removes the remaining ambiguities. It is important to note that the subject of the previous session is evaluated by the researcher and at the beginning of each session by asking one or two questions. For one person and the absence of a family member in the third training session, leads to their removal from the entire study.
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
Hazrat Ali Asghar Hospital in Tehran
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
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
+98 912 622 3904
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 Hossein Keyvani
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
Associate 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
Associate 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 updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
Position
Associate 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
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 identity 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
Email address:khoshnezhad.hr@iums.ac.ir
What processes are involved for a request to access data/document
After submitting the application via academic email, we will provide the information files to the individuals within a maximum of one week.