The aim of this study is determination of effect of Behavioral intervention on Sleep disorder in school age children. The project was approved by the Iran University of Medical Sciences and all participants will complete informed consents prior to participation. Cluster random sampling will be done within 22 regions of Tehran. All participants will complete a demographic questionnaire and screening BRARS pretest measures at the beginning of the intervention.The intervention included a sleep hygiene education session with principal investigator. Participants will complete posttest measures at four and 12 weeks after the completion of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412031788N9
Registration date:2015-08-02, 1394/05/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-08-02, 1394/05/11
Registrant information
Name
Leili Borimnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6150 4212
Email address
borimnej@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Centre for Nursing Care Research Iran University of Medical Sciences
Expected recruitment start date
2015-09-20, 1394/06/29
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 Behavioral intervention on sleep problem in school age childern
Public title
behavioral intervention on sleep problems
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: 6-12 years old; sleep disorder based on BEARS Questionnare
Exclution Criteria: Receiving specialised help for their sleep from a psychologist or a specialised sleep clinic
Age
From 6 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
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
Iran University of Medical Sceiences
Street address
Hemmat
City
Tehran
Postal code
Approval date
2015-04-21, 1394/02/01
Ethics committee reference number
IR.IUMS.REC.1394.25011
Health conditions studied
1
Description of health condition studied
sleep disorder
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
Primary outcomes
1
Description
sleep disorder
Timepoint
before,after 4 week , after 12 week
Method of measurement
Bears Questionnare
Secondary outcomes
empty
Intervention groups
1
Description
Control group: NO Intervention
Category
N/A
2
Description
All parents will received the sleep hygiene education programme delivered, in a session to the participant by the principal investigator. During the intervention session approximately 45-60 minutes, A handout containing all the information covered will be given to the parent(s). Families will offer one follow-up telephone call four weeks later
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Primary School in Tehran
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Center for Nursing Care Research Iran University of Medical Sceinces
Full name of responsible person
Sedighe Khanjari
Street address
Yasemi Street
City
Tehran
Grant name
Grant code / Reference number
25011
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Center for Nursing Care Research Iran University of Medical Sceinces
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
Iran University of Medical Sciences
Full name of responsible person
Leili Borimnejad
Position
Ph.D Educational Affair
Other areas of specialty/work
Street address
Yasemi Street Nursing and Midwhery School
City
Tehran
Postal code
Iran
Phone
+98 21 8827 0263
Fax
Email
l.borimnejad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leili Borimnejad
Position
Ph.D Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery School Yasemi Street
City
Tehran
Postal code
Phone
+98 21 8827 4250
Fax
Email
l.borimnejad@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)