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The effect of a sleepHygiene Intervention on sleep Habits among of elementary students

Protocol summary

Study aim
Determine The effect of a sleep hygiene Intervention on sleep habits among of elementary students
Design
randomized controlled trial
Settings and conduct
In the beginning of the study, randomly from four school from districts 1 and 2 arak were selected. The number of each groups were 50 people.
Participants/Inclusion and exclusion criteria
(Inclusion criteria: Informed consent was signed by parents, Students study at elementary state schools, No Behavioral Disorders in Student, Life with Father and Mother) (Exclusion criteria: The absence of parents and students at training sessions, Unwilling to participate in the study, The student can not be reached at the time of completing the questionnaire and transfer to another school.)
Intervention groups
Intervention group Four educational sessions of 90 minutes hold about Sleep Hygiene, by present education, the book and education pamphlet which this study was hold by helping school administrators. In the end, after three months, questionnaires in this respect shall be filled by mothers of the participating students and the control group is also given the training packages which.
Main outcome variables
( Determine and compare educational intervention, sleep habits, bedtime resistance, sleep onset latency, sleep duration, sleep anxiety, sleep waking, sleep disturbance, sleep breathing , daytime sleepiness, student age,gender student, mother of education, occupation of Mother on the sleep habits of elementary students.)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180526039849N1
Registration date: 2018-07-07, 1397/04/16
Registration timing: retrospective

Last update: 2018-07-07, 1397/04/16
Update count: 0
Registration date
2018-07-07, 1397/04/16
Registrant information
Name
Masoomeh Masnabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3405 0748
Email address
m.masnabadi95@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-05, 1396/09/14
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a sleepHygiene Intervention on sleep Habits among of elementary students
Public title
The Effect of a sleep Hygiene Intervention on sleep Habits among of elementary students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent was signed by parents Students study at elementary state schools No Behavioral Disorders in Students Life with Father and Mother
Exclusion criteria:
The absence of parents and students at training sessions Unwilling to participate in the study The student can not be reached at the time of completing the questionnaire and transfer to another school
Age
From 7 years old to 12 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Multi-stage cluster randomization
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 arak university of Medical Sciences
Street address
Pardis Educational Complex, Department Of Education And Research, Basij S.q
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2017-12-03, 1396/09/12
Ethics committee reference number
IR.ARAKMU.REC.1396.200

Health conditions studied

1

Description of health condition studied
Sleep Hygiene
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
(Determine and compare educational intervention, sleep habits, bedtime resistance, sleep onset latency, sleep duration, sleep anxiety, sleep waking, sleep disturbance, sleep breathing disorder, daytime sleepiness, student age, school gender, mother of education, occupation of Mother on the sleep habits of elementary students)
Timepoint
Before the intervention and three months after the intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The Intervention group of this study consisted of 50 Elementary school girls ofarak city which four educational sessions of 90 minutes hold about Sleep hygiene, by present education, the book and education pamphlet which this process was hold by helping school administrators.
Category
Other

2

Description
The control group of this study consisted of 50 Elementary school girls ofarak. Simultaneously with the intervention group, after three months, questionnaires in this respect shall be filled by Mothers of the participating students the control group is also given the training packages which intervention group has given about Sleep hygiene.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Elementary School Girls
Full name of responsible person
Masoomeh Masnabadi
Street address
No.31, Ghorban Hoseinieh., Hatam Abadi Shahid Ave., Sedal Shohada Ave.
City
Arak
Province
Markazi
Postal code
3817644913
Phone
+98 86 3405 0748
Email
M.Masnabadi95@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mrs Dr Nasrin Roozbahani
Street address
Pardis Educational Complex, Department Of Education And Research, Basij S.q
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
Roozbahani7281@gmail.com
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
Mrs Dr Nasrin Roozbahani
Position
Health Education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Pardis Educational Complex, Department Of Education And Research, Basij S.q
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
Roozbahani7281@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mrs Dr Nasrinn Roozbahani
Position
Health Education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Pardis Educational Complex, Department Of Education And Research, Basij S.q
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
Roozbhani7281@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masoomeh Masnabadi
Position
Master of science
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 31, Ghorbane Hoseinie., Hatam Abadi Shahid Ave., Sedal Shohada Ave.
City
Arak
Province
Markazi
Postal code
3817644913
Phone
+98 86 3405 0748
Email
M.Masnabadi95@arakmu.ac.ir

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
No more information
Study Protocol
No - There is not 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
No - There is not 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
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