Study of effect of sleep hygiene education and sleep reform education on emotional indicators and memory function in Shiraz traumatic brain injury patients.
(1) Objectives: Study of effect of sleep hygiene education and sleep reform education on depression, anxiety and stress in Shiraz traumatic brain injury patients in 1393 and study of effect of sleep hygiene education and sleep reform education on memory function in Shiraz traumatic brain injury patients in 1393.
(2) Design: Randomizing; 2-3 Trial phase; not blinded; without placebo.
(3) Setting and conduct:
After selecting their patients they were divided into intervention and control groups randomly.The intervention group were instructed and fill out the questionnaires. The control group filling out questionnaires but They not be manipulated. All patients completed the questionnaires after one and three months.Intervention group to be followed by telephon weekly.
(4)sample volume: 60
(5) Participants including major eligibility criteria:
Inclusions: The range of age 18-65 years old; ability of reading and writing 6 class at least; no previous disabler injury or due stroke injury.
Exclusion: non inclination of patient for partnership in study; appearance severe psychiatric disorder; non appearance of sleep disorder.
(6) Intervention: Sleep hygiene and reform education is given to the intervention group patients in a verbal one-hour sessions. In addition, two verbal follow up sessions with one and three-month interval and weekly telephone follow-up will be done.
(7) main outcome : Improvement of sleep disorders in brain damage patients and improvement of emotional disorders and memory problems in brain damage patients.
(8)Intervention time 2014.7.23 to 2014.12.21
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041917334N1
Registration date:2014-08-04, 1393/05/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-04, 1393/05/13
Registrant information
Name
Asieh Chanor
Name of organization / entity
Shiraz Medical sciense university
Country
Iran (Islamic Republic of)
Phone
+98 711230541019
Email address
chanor@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz medical sceinse university
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effect of sleep hygiene education and sleep reform education on emotional indicators and memory function in Shiraz traumatic brain injury patients.
Public title
Effect of sleep hygiene education on emotions and memory of Shiraz traumatic brain injury patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusions: The range of age 18-65 years old; Ability of reading and writing 6 class at least; No previous disabler injury or due stroke injury.
Exclusion: Non inclination of patient for partnership in study; Appearance severe psychiatric disorder; Non appearance of sleep disorder.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethical committee of Shiraz medical sciences university
Street address
Zand street, Shiraz
City
Shiraz
Postal code
Approval date
2014-02-16, 1392/11/27
Ethics committee reference number
CT-92-6879
Health conditions studied
1
Description of health condition studied
trumatic brain injory
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Sleep disorders
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep(Inso(mnia)
Primary outcomes
1
Description
Sleep disorders
Timepoint
Before intervention, one month after intervention and 3 month after intervention
Method of measurement
Pittsburg sleep quality questionnaire(PSQI)
Secondary outcomes
1
Description
Memory function
Timepoint
Before intervention, one month and 3 month after intervention
Method of measurement
memory questionnaire (MFQ)
2
Description
emotional indicators (depression, anxiety and strees)
Timepoint
before intervention, one month and 3 month after intervention
Method of measurement
DASS questionnaire
Intervention groups
1
Description
Education of sleep hygiene done on intervention group.
Category
Behavior
2
Description
Any intervention done on control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid rajai hospital
Full name of responsible person
Hoseinali khalili
Street address
Chamran street, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Shiraz University of Medical Sciences
Full name of responsible person
Post frosh
Street address
Medical science university building, Zand street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Shiraz 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
Shiraz medical science university
Full name of responsible person
Asieh chanor
Position
Student
Other areas of specialty/work
Street address
Zand street, shiraz
City
Shiraz
Postal code
Phone
+98 71 1826 2956
Fax
Email
Chanoratie@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz medical sciense university
Full name of responsible person
Arash Mani
Position
PhD in Cognitive Neuroscience
Other areas of specialty/work
Street address
Hafez hospital, chamran street, shiraz
City
Shiraz
Postal code
Phone
+98 71 1627 9319
Fax
Email
Mania@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz medical sciense university
Full name of responsible person
Asieh chanor
Position
Student
Other areas of specialty/work
Street address
Isargaran set, Rahmat street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1826 2956
Fax
Email
Chanoratie@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)