Determining the effect of intervention based on Orem self-care model on anxiety of mothers with children with febrile seizures
Design
A randomized, single-blind, placebo uncontrolled clinical trial to be performed on 70 participants. The block method will be used for randomization.
Settings and conduct
This study will be performed in Amir Kabir Hospital in Arak on mothers who have children with febrile seizures. Participants are randomly divided into intervention and control groups and data analyzer willn't know about the assignment of individuals in the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study; fluency in Persian; reading and writing skills; access to smart phones, internet and cyberspace; not having addiction of mothers to drugs; not having history of sedative drugs consumption among mothers.
Exclusion criteria: Diagnosis of a disease other than febrile seizures in the child.
Intervention groups
Intervention group: At first, the level of information and ability of each mother (individually) about the disease and proper care in case of fever and seizures will be assessed through a written test and a simulation model. Then, based on the level of information, the intervention will begin. Each mother will be individually trained on anxiety management skills for 60 to 90 minutes for three days. In order to ensure the improvement of the mother's performance and the consolidation of the education, the content will be sent to the mothers in the form of videos, photos, SMS and voice messages again through WhatsApp messenger for three weeks.
Control group: The control group will not receive any intervention.
Main outcome variables
Level of anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200529047593N1
Registration date:2020-09-09, 1399/06/19
Registration timing:registered_while_recruiting
Last update:2020-09-09, 1399/06/19
Update count:0
Registration date
2020-09-09, 1399/06/19
Registrant information
Name
Elham Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 6730
Email address
e.mohammadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-31, 1399/06/10
Expected recruitment end date
2020-11-30, 1399/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intervention based on Orem self-care model on anxiety of mothers with children with febrile seizures
Public title
The effect of intervention based on self-care model on anxiety of mothers with children with febrile seizures
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Fluency in Persian
Reading and writing skills
Access to smart phones, internet and cyberspace
Not having addiction of mothers to drugs
Not having history of sedative drugs consumption among mothers
Exclusion criteria:
Diagnosis of a disease other than febrile seizures in the child
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the samples were selected using convenience sampling and then randomly assigned to intervention and control groups using block randomization.
Initially, 6 blocks will made (ABAB, ABBA, BBAA, BABA, BAAB, AABB). Then these blocks are arranged using a table of random numbers and people are divided into two groups according to the letters of A (intervention group) and B (control group).
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer willn't know about the assignment of individuals in the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2020-02-16, 1398/11/27
Ethics committee reference number
IR.ARAKMU.REC.1398.321
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety score in Spielberger inventory
Timepoint
In the pre-test stage (before the intervention), 3 and 21 days (three weeks) after the intervention.
Method of measurement
The Spielberger state-trait anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At first, the level of information and ability of each mother (individually) about the disease and proper care in case of fever and seizures will be assessed through a written test and a simulation model. Then, based on the level of information, the intervention will begin. Each mother will be individually trained on anxiety management skills for 60 to 90 minutes for three days. In order to ensure the improvement of the mother's performance and the consolidation of the education, the content will be sent to the mothers in the form of videos, photos, SMS and voice messages again through WhatsApp messenger for three weeks.
Category
Behavior
2
Description
Control group: routine care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-Kabir Hospital
Full name of responsible person
Esmaeil Moshiri
Street address
Amir-Kabir Hospital, Parastar Sq., Rah-ahan Sq., Shiroodi St.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 4715
Email
info@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Elham Mohammadi
Position
Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
elham.mohammadi1364@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Elham Mohammadi
Position
Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
elham.mohammadi1364@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Elham Mohammadi
Position
Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
elham.mohammadi1364@yahoo.com
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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome and the final result can be shared.
When the data will become available and for how long
24 months after the publishing of the results.
To whom data/document is available
Researchers in academic and scientific institutions.
Under which criteria data/document could be used
Scientific purposes.
From where data/document is obtainable
Elham mohammadi
elham.mohammadi1364@yahoo.com
What processes are involved for a request to access data/document
Upon receipt of the request, the information will be sent within 2 to 3 working days.