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The effect of group psychoeducational program on caregiverburden and quality of life for families of children & adolescents with epilepsy admitted to selected centers of Isfahan University of Medical Sciences in 2017 – 2018

Protocol summary

Summary
The present study aims to investigate the ways to improve the care and quality of life among families of the children and adolescents suffering from epilepsy. This study is a two-group, three-stage, and one-blind clinical trial. In this study, 70 family caregivers of children & adolescents with epilepsy who met the inclusion criteria are selected via simple sampling. The samples are randomly assigned to two groups of test and control. Having a member with epilepsy and the ability to attend training sessions were the most important criteria for entering this study. If, for any reason, caregivers have more than two absences in the sessions, they will be eliminated. (If, for any reason, the caregiver misses more than one meeting of the training sessions, he/she will be eliminated). Data collection was done by the Zarit Care Weight Questionnaires and World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). They were completed by the two groups in three steps of before, immediately after and one month after the intervention. By comparing the results obtained from this study, we can determine the effect of group psychosocial training on care burden and quality of life of the caregivers and, in case of being positive, to be used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017080335483N1
Registration date: 2017-09-15, 1396/06/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-09-15, 1396/06/24
Registrant information
Name
Zeinab Balouchi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3739 3214
Email address
z.balouchi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group psychoeducational program on caregiverburden and quality of life for families of children & adolescents with epilepsy admitted to selected centers of Isfahan University of Medical Sciences in 2017 – 2018
Public title
The effect of group psychoeducational program on caregiverburden and quality of life for families of children & adolescents with epilepsy
Purpose
Supportive
Inclusion/Exclusion criteria
Entry criterion: Family care is considered as the main caregiving agent of the patient and they have a great deal of responsibility. In each family, the one who is the main caregiver, attends the study; he or she must not be drug-addicted and not to be treated with psychosocial drugs. The must not have participated in family education meetings. (any other researcher project in this field); there must be only one chronic caregiver in the family; must not have psychosocial problems that may cause the disease to develop; they must have at least one year of patient care; patients must be aged 6-18 years, the caregiver age is over 18 and under 65 years old. Exclusion criteria: there are physical and psychological problems that cannot continue to participate in the study; they have irregular participation in the sessions (having more than two absences).
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Isfahan University Of Medical Sciences
Street address
College of Nursing and Midwifery, Isfahan University Of Medical Sciences, Hezar Jarib, Isfahan, Iran
City
Isfahan
Postal code
8174673461
Approval date
2017-05-17, 1396/02/27
Ethics committee reference number
IR.MUI.REC.3.052

Health conditions studied

1

Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy

Primary outcomes

1

Description
Caregiver burden
Timepoint
Before, immediately after and one months after the intervention
Method of measurement
zarit burden Questionnaire

Secondary outcomes

1

Description
quality of life
Timepoint
Before, immediately after and one month after the intervention
Method of measurement
WHOQOL-BREF instrument

Intervention groups

1

Description
The researcher of his intervention program, which is a supportive educational tool, performs in 8 ( 90-minute ) sessions for family members of children and adolescents with epilepsy who are eligible
Category
N/A

2

Description
the control group will participate in 3 sessions that organized by fellow researcher, and they will discuss and share their experiences
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Zeinab Balouchi
Street address
Ayatollah Kashani Hospital, Ayatollah Kashani st.
City
Isfahan

2

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Zeinab Balouchi
Street address
Imam Hossein Hospitall, imam khomeini st.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ashraf Kazemi
Street address
Isfahan University of Medical Sciences, Hezar Jereb St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Saied Pahlavanzadeh
Position
Master of Science in Psychiatric Nursing / Registered Psychiatric Nursing and Midwifery Faculty
Other areas of specialty/work
Street address
Isfahan University of Medical Siences, Hezar jarib St., Azadi Sq.
City
]sfahan
Postal code
Phone
+98 31 3668 7124
Fax
Email
pahlavanzadeh@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zeinab Balouchi
Position
Bachelor of Nursing / Psychiatric Nursing Graduate Student Contact details
Other areas of specialty/work
Street address
Koy 131, Ashrafi Isfahani st., rehnan
City
Isfahan
Postal code
Phone
+98 31 3719 3214
Fax
Email
z.balouchi@nm.mui.ac.irzeinabbalouchi1@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zeinab Balouchi
Position
Bachelor of Nursing / Psychiatric Nursing Graduate Student Contact details
Other areas of specialty/work
Street address
Ashrafi Esfahani Street, Rehanan, Kohi 131,
City
Isfahan
Postal code
Phone
+98 31 3739 3214
Fax
Email
z.balouchi@nm.mui.ac.ir & zeinabbalouchi1@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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