Development and evaluation of the effectiveness of virtual education program for healthy sleep pattern on sleepiness reduction in 15 to 17 years old female students.
Determining and comparing the effectiveness of the educational intervention on the average score of the sleepiness of the intervention group compared to the control group before, after, and 3 months after the intervention in female students aged 15 to 17
Design
Before and after clinical trial, has a control group, randomized, not blinded on 103 participants
Settings and conduct
Girls' high schools in Abdanan, Ilam province Is place of intervention,
The intervention is done virtually using the SHAD program and Whats App Groups
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.High school female students
2.willing to participate in the study
3.Parents' consent to participate in the study
exclusion criteria:
1. use of medication for sleep disorders
Intervention groups
Intervention group: Female high school students 15 to 17 years old: 53 students in the experimental group, do receive an educational intervention based on self-regulation theory aims to improve sleep health and reduce sleepiness in school students.
Control group: Female high school students 15 to 17 years old: 53 students in the control group do not receive any educational intervention.
Main outcome variables
The sleep knowledge
Positive attitude to sleep behavior
Self-efficacy of sleep behavior
The quantity and quality of sleep
Self-regulatory sleep behavior
The sleep hygiene
Sleepiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201107049293N1
Registration date:2021-02-01, 1399/11/13
Registration timing:registered_while_recruiting
Last update:2021-02-01, 1399/11/13
Update count:0
Registration date
2021-02-01, 1399/11/13
Registrant information
Name
parvin ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3204
Email address
parvin_ghasemi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development and evaluation of the effectiveness of virtual education program for healthy sleep pattern on sleepiness reduction in 15 to 17 years old female students.
Public title
The effectiveness of healthy sleep pattern education in sleepiness reduction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Female students studying in high school
Parents' consent to participate in the study
willing to participate in the study
Exclusion criteria:
The usage of medication which causes sleep disorders
Age
From 15 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
A two-arm parallel-randomized controlled trial with sleep intervention and a control group, with 53 people sample size in each group.
Using simple randomization method, two school will be randomly selected out of five schools. Out of two schools, one is randomly assigned to control group and one to the experimental group. Then, in every school each class is given a number and two numbers randomly will be selected and assigned to the experimental and control classes. In this study, to units of the statistical society (schools or classes) will be assigned a card number and then will be put all the cards in a box And every time after shaking the box, we will be Draw the card randomly from the box.
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 Isfahan University of Medical Sciences
Street address
Hezar Jerib street, Isfahan University of Medical Sciences,Isfahan
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2020-10-18, 1399/07/27
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.460
Health conditions studied
1
Description of health condition studied
The students sleepiness
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean sleep knowledge score
Timepoint
Before, after and 3 months after the intervention
Method of measurement
Cognitive variables questionnaire
2
Description
Mean score of sleep health
Timepoint
Before, after and 3 months after the intervention
Method of measurement
Adolescent Sleep Hygiene Scale
3
Description
Mean score quality of sleep
Timepoint
Before, after and 3 months after the intervention
Method of measurement
Pittsburgh Sleep Quality Index
4
Description
Mean score of self-regulation sleep behavior
Timepoint
Before, after and 3 months after the intervention
Method of measurement
Sleep Behavior Self-Regulation Questionnaire
5
Description
Mean score of sleepiness
Timepoint
Before, after and 3 months after the intervention
Method of measurement
Cleveland Adolescent Sleepiness Questionnaire
6
Description
Attitude towards sleep
Timepoint
Before, after and 3 months after the intervention
Method of measurement
Cognitive variables questionnaire
7
Description
Mean score of sleep behavior self-efficacy
Timepoint
Before, after and 3 months after the intervention
Method of measurement
Cognitive variables questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 15-17-year-old female high school students. Self-regulation theory is the selection of intervention components and behavior change techniques and is the basis of all educational materials. Students in the sleep education program will receive 12 sessions (30 minutes each) online. The training program used in this study will include sleep knowledge, sleep hygiene and goal setting, self-control (including metacognitive and motivational strategies) and self-reflection.The content of the training will be presented to the intervention group in the form of PowerPoint, multimedia, short audio and text files. The intervention group will be invited to join a social network for example, WhatsApp or Instagram for 12 weeks to share their experiences with barriers and solutions to overcome healthy sleep barriers. A telephone consultation will be added to the program to maximize program participation and increase problem-solving and self-regulation skills. Educational intervention will be done in SHAD program and a link to educational sessions will be sent to students every week. Coordination and planning will be done with the school principal before the intervention.
Category
Lifestyle
2
Description
Control group: 17-15 year old female high school students. Students in the control group do not receive educational intervention But the content of the training will be provided to them after the end of the study.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Girls' high schools in Abdanan
Full name of responsible person
Parvin Ghasemi
Street address
Sarab ave.Abdanan
City
Abdanan
Province
Ilam
Postal code
6971739185
Phone
+98 31 3792 3204
Email
parvin_ghasemi@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Amidi Mazaheri
Street address
Hezar Jerib street, Isfahan University Of Medical Science
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3792 3204
Email
maryamamidi@hlth.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Parvin Ghasemi
Position
Phd student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hezar Jerib street,, Isfahan University of Medical Sciences.Faculty of Health
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3792 3204
Email
parvin_ghasemi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Amidi Mazaheri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Health Promotion
Street address
Hezar Jerib street, Isfahan University Of Medical Science ,Faculty of Health
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3792 3204
Email
maryamamidi@hlth.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parvin Ghasemi
Position
Ph.D student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hezar Jerib street, Isfahan University Of Medical Science.Faculty of Health
City
Isfahan
Province
Isfehan
Postal code
کد پستی: ۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3792 3204
Email
parvin_ghasemi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data and results of the intervention and the intervention protocol potentially will be published as a scientific article
When the data will become available and for how long
Accessibility after printing results
To whom data/document is available
There is no limitation for statistical analysis
Under which criteria data/document could be used
Obtaining official permission from Isfahan University of Medical Sciences - Contact the research team-There is no limitation for statistical analysis
From where data/document is obtainable
Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Obtaining official permission from Isfahan University of Medical Sciences - Contact the research team