Investigation of the effect of psychoeducation program on anxiety, depression and Quality of life of caregivers of children with cerebral palsy
Design
Clinical trial, without control group, pre/post design
Settings and conduct
The present study will be conducted at the Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences. In this clinical trial, 15 carers of children with cerebral palsy referred to occupational therapy clinics of Semnan city will be selected by simple random method. After selecting participants for research and obtaining informed consent, evaluations of anxiety, depression and quality of life will be made from the participants. The evaluations will be carried out in two other sessions, immediately after the completion of the treatment sessions, and after a 2 month follow-up period. The protocol of the psychoeducation program is 5 sessions of a group intervention program including training programs and supportive group therapy.
Participants/Inclusion and exclusion criteria
The inclusion criteria for these carers are as follows:1: The age range of these carers will be between 25 and 40 years old.2: Children's age range will be 2-7 years old. 3: Children at movement level 3 or 4 or 5 (GFMCF). 4: Carers have at least a fifth grade elementary degree. 5:Detection of cerebral palsy is definite. Exclusion criteria includes of absence of a participant in a session of the sum of psychological training sessions and unwillingness to stay in research
Intervention groups
The intervention group includes caregivers for children with cerebral palsy.
Main outcome variables
Anxiety level; Depression; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181130041807N1
Registration date:2019-02-07, 1397/11/18
Registration timing:prospective
Last update:2019-02-07, 1397/11/18
Update count:0
Registration date
2019-02-07, 1397/11/18
Registrant information
Name
Hossein Alibakhshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
alibakhshi@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of psychoeducation program on anxiety, depression and Quality of life of caregivers of children with cerebral palsy
Public title
The effectiveness of psychoeducation on caregivers of children with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of these carers will be between 25 and 40 years old.
Children's age range will be 2-7 years old
Children will be at the level of 3,4 or 5 of the Gross Motor Function Classification System (GMFCS)
Carers have at least a fifth grade elementary degree.
Detection of cerebral palsy is definite
Exclusion criteria:
Absence of a participant in a session of the sum of psychoeducational sessions
Unwillingness to stay in research
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2019-01-15, 1397/10/25
Ethics committee reference number
IR.SEMUMS.REC.1397.259
Health conditions studied
1
Description of health condition studied
Depression , Anxiety , Cerebral palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy
Primary outcomes
1
Description
Anxiety: A score that is obtained using the Beck Anxiety Scale.
Timepoint
Before the intervention, immediately after the intervention and after a 2 month follow-up period
Method of measurement
Beck Anxiety questionnaire
2
Description
Depression: The score used by the Beck Depression questionnaire.
Timepoint
Before the intervention, immediately after the intervention and after a 2 month follow-up period
Method of measurement
Beck Depression questionnaire
3
Description
Quality of Life: The score obtained using the SF36 questionnaire.
Timepoint
Before the intervention, immediately after the intervention and after a 2 month follow-up period
Method of measurement
SF36 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After providing initial information about the participants and obtaining informed consent, anxiety, depression and quality of life will be assessed by Beck Anxiety Inventory, Beck Depression Inventory and SF36 Form. These evaluations will be resumed after the completion of the treatment sessions and after a follow-up period of 2 months. The psychoeducation protocol includes 5 sessions of the group psychoeducational program, including educational programs and supportive group therapy.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabatabaei Rehabilitation Clinic, Semnan
Full name of responsible person
Hossein Alibakhshi
Street address
Ghods
City
Semnan
Province
Semnan
Postal code
1234567890
Phone
+98 23 3334 0867
Email
halibakhshi.m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
دکتر پرویز کوخایی
Street address
Basij Blvd.
City
Semnan
Province
Semnan
Postal code
1234567890
Phone
+98 23 3344 1022
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Alibakhshi Hossein
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
قدس
City
Semnan
Province
Semnan
Postal code
1234567890
Phone
+98 23 3334 0867
Email
halibakhshi.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Alibakhshi Hossein
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
قدس
City
Semnan
Province
Semnan
Postal code
1234567890
Phone
+98 23 3334 0867
Email
halibakhshi.m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Alibakhshi Hossein
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Ghods
City
Semnan
Province
Semnan
Postal code
1234567890
Phone
+98 23 3334 0867
Email
halibakhshi.m@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available