The Impact of Educational Intervention by Interactional Multi Media based on Health belief model on preventive behavior about pediculosis in primary school students
Determining the Effect of Educational Intervention Using Interactive Multimedia Method Using Health Belief Model on Pediculosis Preventive Behavior in Primary School Students in First and Second Periods in Bavanat, 1397
Design
In this study, 300 primary school students who are eligible to enter the study are selected. Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
This double-blind clinical trial is conducted in elementary girl schools in the Bavanat city. In this trial one session will be conducted by multimedia for the intervention group and no intervention will be conducted for the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Written consent from students' parents; Students own desire and willingness to participate in the study; no previous involvement with lice related training. Non inclusion criteria: having affected by skin disease and fungi before; Change the place of residence or education
Intervention groups
For the intervention group, 1 session will be held in an interactive and multimedia format. No intervention will be conducted for the control group.
Main outcome variables
Preventive behaviors of pediculosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180806040715N2
Registration date:2019-02-15, 1397/11/26
Registration timing:prospective
Last update:2019-02-15, 1397/11/26
Update count:0
Registration date
2019-02-15, 1397/11/26
Registrant information
Name
zahra keshtkaran
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5233 7546
Email address
zkeshtkar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Educational Intervention by Interactional Multi Media based on Health belief model on preventive behavior about pediculosis in primary school students
Public title
The Effect of Training on Lice pediculosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Obtain written consent from parents of students
Satisfaction and desire of students to participate in the study
Students studying at elementary girl schools
No participation of students in sessions on prevention of head lice
Exclusion criteria:
Skin and fungus diseases
Change the student's residence or school
Age
From 6 years old to 12 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning samples to the test and control groups is based on the randomized block method in which we select letter “A” for control group and letter "B” for intervention group. In this way, we will consider block of size 2 with two modes including “AB” and “BA”.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are not aware of which group they are involved with and control. The data analyzer does not know who the participants are in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-11-27, 1397/09/06
Ethics committee reference number
IR.SUMS.REC.1397.800
Health conditions studied
1
Description of health condition studied
The Effectiveness of a Health Education Program Based on the Health Belief Model on Students
ICD-10 code
Z55.8
ICD-10 code description
Other problems related to education and literacy
Primary outcomes
1
Description
Perceived susceptibility
Timepoint
Before, after the intervention, two months later
Method of measurement
Researcher made questionnaire
2
Description
Perceived severity
Timepoint
Before, after the intervention, two months later
Method of measurement
Researcher made questionnaire
3
Description
Perceived Barriers
Timepoint
Before, after the intervention, two months later
Method of measurement
Researcher made questionnaire
4
Description
Perceived benefits
Timepoint
Before, after the intervention, two months later
Method of measurement
Researcher made questionnaire
5
Description
Efficacy
Timepoint
Before, after the intervention, two months later
Method of measurement
Researcher made questionnaire
6
Description
Cues to action
Timepoint
Before, after the intervention, two months later
Method of measurement
Researcher made questionnaire
7
Description
Preventive Behaviors
Timepoint
Before, after the intervention, two months later
Method of measurement
Researcher made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group: A training session is conducted using an interactive multimedia method in which female students are trained lice prevention behaviors
Category
Prevention
2
Description
In the control group, there is no intervention and they will be provided with educational materials at the end of the study.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
primary schools students in Bavanat
Full name of responsible person
Kadijeh Kiani
Street address
Nursing and Midwifery School, Namazi square
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4258
Email
kh.kiani.nurse85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Central building of Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3235 7282
Email
Vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Kiani
Position
Bachelor
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery school, Namazi Square
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3731 6873
Email
kh.kiani.nurse85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Keshtkaran
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery school, Namazi Square
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4258
Email
zkeshtkar@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Kiani
Position
Bachelor of science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery school, Namazi Square
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3731 6873
Email
kh.kiani.nurse85@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of the participants' information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information on the main consequences
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
If requested, the researchers will be provided by the first moderator
Under which criteria data/document could be used
Presenting articles at prestigious seminars and presenting articles in prestigious scientific journals
From where data/document is obtainable
First performer Dr. Zahra Keshtkaran zkeshtkar@sums.ac.ir
What processes are involved for a request to access data/document