Present study is a randomized clinical trial which will be conducted in order to evaluate the effectiveness of psychiatric rehabilitation (Dosaho) on sleep quality of 4 to 12 years old children with cerebral palsy. The population of the study is all children with cerebral palsy in Yazd who will be chosen using convenience sampling method and according to the inclusion criteria, suffering from cerebral palsy and age range of 4 to 12, 30 male patients will be assigned randomly into experimental and control groups. Before the treatments the children’s parents will consciously fill out the sleep quality questionnaire and at the end of the treatment, in the post-test phase, this assessment will be done again. The treatment duration is 12 sessions, held 3 sessions a week and each session is 50 minutes.
The intervention will consist of 12 sessions of 50-minute psychological rehabilitation program using Dosaho method for patients with cerebral palsy which was designed and taught in Japan by Professor Naroseh. The program consists of psychological and hysiological parts which are taught by the therapist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012026120N1
Registration date:2016-04-03, 1395/01/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-03, 1395/01/15
Registrant information
Name
zahed kanani
Name of organization / entity
University of Social Welfare and Rehabilitation sciences
Country
Iran (Islamic Republic of)
Phone
+98 919 702 7789
Email address
ramtinkanani@yahoo.com
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2014-01-25, 1392/11/05
Expected recruitment end date
2014-03-11, 1392/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Psycho-Rehabilitation (Dohsa-hou) on Quality of sleep of Boys (aged 4-12) with Cerebral Palsy
Public title
The Effectiveness of Psycho-Rehabilitation (Dohsa-hou) on Quality of sleep of Boys (aged 4-12) with Cerebral Palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: suffering from cerebral palsy diagnosed by a specialist, age range of 4 to 12.
Exclusion criteria: severe mental disorder; a change in medicine, like anticonvulsants and sedatives, in the last one month which may affect sleep; suffering from other chronic disorders or sensory disorders which may interrupt participating in the program; and more than 2 absents in the treatment program.
Age
From 4 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Tehran University of Social Welfare and Rehabilitation Science
Street address
Kodakyar Street, Daneshjoo Boulevard, Evin, Tehran
City
Tehran
Postal code
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
92/10/17
2
Ethics committee
Name of ethics committee
Tehran University of Social Welfare and Rehabilitation Science
Street address
Kodakyar Street, Daneshjoo Boulevard, Evin, Tehran
City
Tehran
Postal code
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
2014/1/7
Health conditions studied
1
Description of health condition studied
Cerebral Palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy
Primary outcomes
1
Description
Quality of Sleep
Timepoint
Before and 2 months after the intervention
Method of measurement
Quality of Sleep Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The intervention will consist of 12 sessions of 50-minute psychological rehabilitation program by Dosah method for patients with cerebral palsy which is designed in Japan by Professor Naroseh will be taught. The program consists of two parts of psychological and physiological which are taught by the therapist.
Category
Treatment - Other
2
Description
Control group: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Zahed Kanani
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Training Center Haj Ahmed zarrabi
Full name of responsible person
Zahed Kanani
Street address
Montazer Qa'em Blvd, Above Mahtab Street
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University Of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr. Asghar Dadkhah
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University Of Social Welfare and Rehabilitation 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
Tehran University of Social Welfare and Rehabilitation sciences
Full name of responsible person
Zahed Kanani
Position
Master Science of Psychology and Education of Exceptional Children
Other areas of specialty/work
Street address
Koodakyar, Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Postal code
Phone
+98 21 2218 0042
Fax
Email
ramtinkanani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Social Welfare and Rehabilitation sciences
Full name of responsible person
Asghar Dadkhah
Position
Master Student of Psychology
Other areas of specialty/work
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Postal code
Phone
+98 21 2218 0045
Fax
Email
asgaredu@uswr.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Social Welfare and Rehabilitation sciences
Full name of responsible person
Zahed Kanani
Position
Master Science of Psychology and Education of Exceptional Children
Other areas of specialty/work
Street address
Koodakyar, Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
ramtinkanani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)