Investigating the effect of combined education on the knowledge and care performance of parents having a child with idiopathic thrombocytopenic purpura
Determine the effect of combined education on the knowledge and care performance of parents having a child with idiopathic thrombocytopenic purpura
Design
The clinical trial has a control group, with parallel groups, the samples will be randomly divided into two groups (N=36 test) and (N=36 control) using a block of 4 method (using the table related to random permutation blocks). There is no blinding.
Settings and conduct
After approving the research and obtaining permission from Jundi Shapur University of Ahvaz and Shafa and Bagai 2 hospitals, the researcher will start random sampling and will explain the confidentiality by presenting a letter of introduction regarding the objectives of the study. In this research, the samples will be selected based on the criteria for entering the study and the samples will be randomly divided into two groups of intervention and control and two groups of demographic questionnaires, measuring knowledge and care performance. It will be performed in 6 sessions of 45 minutes (one session per week).
Participants/Inclusion and exclusion criteria
The age of the child is 2 to 8 years At least 6 months have passed since the diagnosis of the child's illness not having a history of uncontrolled underlying diseases; having a child with chronic idiopathic thrombocytopenic purpura ; parents have the ability to receive education; Lack of parents' participation in the previous class; parents' ability to answer questions and conditions of non-entry; Age less than 2 more than 8 years and not mastering Persian language
Intervention groups
For the intervention group, a combination of face-to-face training and educational video screening will be conducted during 6 sessions of 45 minutes, one session per week. Training is not done.
Main outcome variables
knowledge of parents ,care performance of parents
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221018056228N1
Registration date:2023-01-07, 1401/10/17
Registration timing:prospective
Last update:2023-01-07, 1401/10/17
Update count:0
Registration date
2023-01-07, 1401/10/17
Registrant information
Name
Ashrafalsadat Hakim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3375 0412
Email address
mehdiafshari7300@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-10, 1401/10/20
Expected recruitment end date
2023-02-09, 1401/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of combined education on the knowledge and care performance of parents having a child with idiopathic thrombocytopenic purpura
Public title
Investigating the effect of combined education on the knowledge and care performance of parents having a child with idiopathic thrombocytopenic purpura
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Child age 2-8 years
At least 6 months have passed since the diagnosis of the child's illness.
Not having a history of uncontrolled underlying diseases.
Having a child with chronic idiopathic thrombocytopenic purpura
Parents have the ability to receive education (at least elementary literacy level).
Lack of parents' participation in previous classes
Parents' ability to answer questionnaire questions
Exclusion criteria:
Age less than 2 and more than 8 years
Lack of proficiency in Persian language
Age
From 2 years old to 8 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 assignment of the research sample to intervention and control groups will be done based on permutation blocks of four (using the table related to random permutation blocks). In this method, the number of people assigned to each group is almost equal. In this method, blocks are formed based on the desired variables and within each block, half of the intervention people and half of the control people are included, the main goal in this method is to balance the number of participants in each of the groups.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2022-10-08, 1401/07/16
Ethics committee reference number
IR.AJUMS.REC.1401.291
Health conditions studied
1
Description of health condition studied
Idiopathic Thrombocytopenic Purpura
ICD-10 code
D69.3
ICD-10 code description
Purpura and other haemorrhagic conditions
Primary outcomes
1
Description
The amount of knowledge and care performance of parents with a child with idiopathic thrombocytopenic purpura
Timepoint
Before the start of the intervention and one month after the intervention
Method of measurement
Researcher-made questionnaire (measurement of knowledge and care performance)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: combined training (face-to-face and educational video showing) will be approved by the relevant doctor, and will be conducted by the researcher in 6 sessions of 45 minutes (one session per week). In order to apply the combined educational method, first the initial explanations will be provided to the parents in the form of face-to-face training and then the training video will be shown to the participants.
Category
Prevention
2
Description
Control group: No educational intervention will be done, but in order to comply with ethical considerations, after analyzing the results, the educational pamphlet will be delivered to the control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqaei 2 Hospital
Full name of responsible person
Ashrafalsadat Hakim
Street address
Baqaei 2 Hospital,Pardis Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3375 0412
Email
hakim3448200@yahoo.com
2
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Ashrafalsadat Hakim
Street address
Shafa Hospital, Golestan St, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3374 3281
Email
hakim3448200@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Ahvaz University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 3817
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ashrafalsadat Hakim
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Pediatrics, Management
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 3817
Email
hakim3448200@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ashrafalsadat Hakim
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Pediatrics, Management
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 3817
Email
hakim3448200@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ashrafalsadat Hakim
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
pediatrics-education-management
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 2392
Email
hakim3448200@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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