Survey the effect of ” Creating Opportunities for Parents Empowerment” Program on anxiety and depression of parents of children with epilepsy and other Chronic Neurological conditions with epileptic attacks
This is a quasi-experimental research. Research samples include 64 mothers of children with epilepsy and other chronic neurological conditions with epileptic attack selected by the gradual sampling method and placed in control and experimental groups. At first, control group will be select and receives usual care. Then, the experimental group will be select and receives ”Creating Opportunities for Parents Empowerment” Program. The first Phase of the C.O.P.E program begins within 24 hours of admission of child in the hospital and included written and audio information regarding children’s expected responses to illness and how caregivers can facilitate the child’s adjustment to the experiences associated with the hospitalization.The second Phase of the C.O.P.E intervention consists of a call, 3 days after discharge from the hospital to reinforce information provided during first phase. At this phase, the control group also receives a call about their satisfaction with hospitalization and discharge processes.The third Phase of the C.O.P.E intervention will be four weeks after the discharge, including present a parent-child activity workbook which teaches mothers how to use play to help the child to cope with medical procedures and hospitalization. The questionnaires will be completed in three phase, before intervention, one week after discharge from hospital and eight weeks after discharge. Expected outcomes will be reduce the anxiety and depression of parents of children with epilepsy and other chronic neurological conditions with epileptic attack under C.O.P.E intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017110712990N9
Registration date:2017-11-19, 1396/08/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Minoo Mitra Cherhzad
Name of organization / entity
Guilan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 5056
Email address
chehrzad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology, Guilan University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of ” Creating Opportunities for Parents Empowerment” Program on anxiety and depression of parents of children with epilepsy and other Chronic Neurological conditions with epileptic attacks
Public title
The effect of ” Creating Opportunities for Parents Empowerment” Program on anxiety and depression of parents of children with epilepsy and other chronic neurological conditions with epileptic attacks
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: mothers of children between 3 and 12 years old with epilepsy and other chronic neurological condition, tendency to participate in the study, doesn't work in health system, absence of a special incident that affects mother's mode such as death of relatives or a financial crisis, ability to read and complete the questionnaire, daily care of the child and telephone access.Exclusion criteria: Disinclination to continuation at each stage of the research, training related to empowerment programs in other way , use of psychological drugs.
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Samples of the control and experimental groups will be homogenized in some personal characteristics such as mother's age, marital status, mother's education and family's income.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences Ethics Committee
Street address
Opposite the 17 Shahrivar Hospital. Shahid Siadati Street, Namjoo Street
City
Rasht
Postal code
4193893345
Approval date
2017-11-04, 1396/08/13
Ethics committee reference number
IR.GUMS.REC.1396.302
Health conditions studied
1
Description of health condition studied
anxiety and depression on parents of children with epilepsy and other chronic neurologic conditions
ICD-10 code
F41.9 ، F3
ICD-10 code description
Mental and behavioural disorders
Primary outcomes
1
Description
anxiety
Timepoint
Before intervention, one week after discharge from hospital, eight weeks after discharge from hospital
Method of measurement
Speilberger state-trait anxiety inventory
2
Description
depression
Timepoint
Before intervention, one week after discharge from hospital, eight weeks after discharge from hospital
Method of measurement
Beck Depression Inventory II (BDI-II)
Secondary outcomes
empty
Intervention groups
1
Description
The experiment group receives ” Creating Opportunities for Parents Empowerment” Program in three phases. The first Phase of the C.O.P.E intervention begins in the first 24 hours of admission (written and audio information), second Phase of the COPE intervention , one week after the discharge (telephone call) and The third Phase of the C.O.P.E intervention , four weeks after the discharge (child-parent work book).
Category
Behavior
2
Description
The control group receives usual care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar pediatric Educational and therapeutic Center
Full name of responsible person
Maryam Jahri Sheijani
Street address
Navab Safavi Street, Golsar Square
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Guilan University of Medical Sciences
Full name of responsible person
Doctor Shadman Nemati
Street address
Opposite the 17 Shahrivar Hospital. Shahid Siadati Street, Namjoo Street
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Maryam Jahri Sheijani
Position
Bachelor's Degree in Nursing / Nurse
Other areas of specialty/work
Street address
Shafa Educational and Remedial Center
City
Rasht
Postal code
4193955999
Phone
+98 13 3366 2350
Fax
Email
hospital_ shafa_ rasht@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Minoo Mitra Chehrzad
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Shahid Beheshti Nursind and Midwifery Faculty of Rasht
City
Rasht
Postal code
4146939841
Phone
+98 133355058
Fax
+98 33550097
Email
chehrzad@gums.ac ; mchehrzad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Maryam Jahri Sheijani
Position
Bachelor's Degree in Nursing / Nurse
Other areas of specialty/work
Street address
Shafa Educational and Remedial Center
City
Rasht
Postal code
4193955599
Phone
+98 13 3366 2350
Fax
Email
hospital_shafa_rasht@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)