Protocol summary

Summary
This study is a clinical trial study that by cluster sampling will be selected primary schools for boys and girls. After completion of CSI-4 questionnaires by the mothers, children who are not psychotic problems are selected. At the beginning of the study to find out the children's sleep quantity, sleep registration of two-week (two week sleep record) will be completed by the mothers and After reviewing the results, Children who suffer with sleep deprivation isolated and randomly will be divided into control and intervention groups. To study the mothers sleep knowledge in both groups, parents-sleep knowledge inventory will be completed by mothers. Then in the intervention group a month to mothers sleep hygiene messages will be sent every day. Upon completion of the one month, two- week sleep record and parents-sleep knowledge inventory will be completed by mothers again. By comparing the two groups at the end the sleep quantity and sleep knowledge will be measured. To study the long-term behavior changes after three months, students will be examined again sleep quantity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201407088315N10
Registration date: 2015-09-25, 1394/07/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-25, 1394/07/03
Registrant information
Name
Leila Valizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
valizadehl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of SMS-Based Education on Mothers Sleep Knowledge and Sleep Quantity among Elementary School Students: A Single-Blind Randomized Clinical Trial
Public title
The Effect of SMS-Based Education on Mothers Sleep Knowledge and Childrens Sleep Quantity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: male and female students that studying in primary school in 2015-2016 years; students that suffering from lack of sleep, according two-week sleep record form (in the age of 7 to 9 years if less than 10 hours and In the age group 10 to 12 years less than 9 hours); Lack of psychotic disorders using questionnaires CSI-4 (completed by the mothers) will be reviewed by fellow psychologist; The lack of children with chronic diseases such as diabetes, liver problems, cancer, etch, which can disrupt sleep; mother's tendency to participate in the research; Having a mobile; literacy mothers (at least FAQ); children aged 7 to 12 years;The child's mother is alive; family members are not medical professionals; The lack of physical or mental illness in parents and family members Exclusion criteria: students who do not complete their mothers recorded sleep and other questionnaires; during the study, mothers who for any reason do not tendency to participate in the research; mothers who did not response to receive the SMS; students who go from that city; mothers who received text messages, for whatever reason not a single ring (maximum half a SMS).
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Azadi Street, Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2015-04-13, 1394/01/24
Ethics committee reference number
TBZMED.REC.1394.18

Health conditions studied

1

Description of health condition studied
The Relationship of SMS-Based Education whit Mothers Sleep Knowledge and Sleep Quantity among Elementary School Students
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
childrens sleep quantity
Timepoint
Before the intervention, Afther the intervention and Tree months afther intervention
Method of measurement
Two-Week Sleep Record Form

2

Description
Mothers Sleep Knowledge
Timepoint
Before the intervention, After the intervention
Method of measurement
PSKI Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
in the intervention group, for Mothers sending training SMS about sleep for a month then Parents- Sleep Knowledge Inventory and Two- Week Sleep Record will be completed by mothers to examine the impact of training SMS and after the three months to assess the lasting impact, Parents- Sleep Knowledge Inventory and Two- Week Sleep Record will be completed by mothers again.
Category
Other

2

Description
In the control group SMS will not be sent and after a month at the same time with intervention group, Parents-Sleep Knowledge Intventory and Two- Week Sleep Record will be completed by mothers.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Primary Schools in Tabriz
Full name of responsible person
Leila Valizadeh
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Azadi Street, Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zeinab Mosarrezaie
Position
MS nursing student
Other areas of specialty/work
Street address
south shariati st., Tabriz Faculty of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
mosarrezaiez@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Valizadeh
Position
Associate Professer
Other areas of specialty/work
Street address
south shariati st., Tabriz Faculty of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
valizadehl@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zeinab Mosarrezaie
Position
MS nursing student
Other areas of specialty/work
Street address
south shariati st., Tabriz Faculty of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
mosarrezaiez@gmaile.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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