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The effect of family-centered care on the family caregivers' burden, stress, anxiety and depression of epilepsy patients .

Protocol summary

Summary
The aim of study was to investigate the effect of family-centered care burden, stress, anxiety and depression in caregivers of patients with epilepsy is eligible after selecting samples (n = 100) and easy conditions for obtaining the informed consent from caregivers, initially based their pretest Inventory burden of care and stress, anxiety and depression DOS will come into action.Afterwards, the random allocation of samples (table of random numbers) to experimental and control groups to participate in family-centered care program (common time executive include: (i) the perceived threat, the second: self-promotion through Problem Solving Group, the third : increased self-esteem through educational partnership and (iv) process evaluation and final evaluation using a questionnaire immediately after and two months after intervention) in Hospital of Ayatollah Kashani invited incorporation. Researcher after the intervention, the control group caregivers, are invited to participate in training sessions and shall manual and training CD delivered to them and their blogs are designed to introduce.The program for the experimental group during the 4 sessions of 2 hours with caregivers and with a constant research team includes neurologist, researcher and done. Each training session presentation and discussion about the experiences of caregivers and care-related problems raised by caregivers, will be held. This care program and give PowerPoint presentations and use the manual, training CD and blog designed for rest.The burden of care variables, caregivers is stress, anxiety and depression. Of the conditions of entry and literacy and the age of consent was 18.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050212452N3
Registration date: 2017-01-07, 1395/10/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-07, 1395/10/18
Registrant information
Name
Shahram Etemadifar
Name of organization / entity
Isfahan University of Medical Sciences, Fculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2969
Email address
etemadifar@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Shahrekord University of Medical Sciences
Expected recruitment start date
2016-07-02, 1395/04/12
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered care on the family caregivers' burden, stress, anxiety and depression of epilepsy patients .
Public title
Effectiveness of care plan on problems caregivers of patients with epilepsy.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: According to patient, their family or carer as caregivers and bear a lot of responsibility of patiens . Age over 18 (and caregivers of patients) years. Be able to communicate and participate in all training sessions. Is not involveded in the family training sessions (any other research project) earlier. According to medical records are not known history of severe physical illness and mental disorder. No other patient care at the same time. Lack of crisis or major stress during the past year. patients have Grand Mal epilepsy type.Caregiver care of patient at least 3 hours daily. Exclusion criteria:Carers are not willing to continue to participate in the study. Other disease during the study, which followed patients require extra care needs. Those are who care for patients who have other diseases in addition to epilepsy, neuromuscular spinal cord injuries, head injuries decreased level of consciousness, mental retardation and visual cognitive disorders, alcoholism and drug abuse, former multiple strokes, mentally ill. Stressful events occurring during the intervention for caregivers. Serious physical disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomized with a random numbers table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahrekord University of Medical Sciences
Street address
Shahr e Kord. Kashani Ave.
City
shahrekord
Postal code
Approval date
2016-11-24, 1395/09/04
Ethics committee reference number
R.skums.REC.46.2125

Health conditions studied

1

Description of health condition studied
epilepsy
ICD-10 code
g41.0
ICD-10 code description
Grand mal status epilepticus Tonic-clonic status epilepticus Excl.: epilepsia partialis continua [Kozhevnikof] (G40.5)

Primary outcomes

1

Description
Burden of care
Timepoint
Before, immediately after and two months after intervention
Method of measurement
Persian and standardized questionnaire Zaryt

2

Description
Stress
Timepoint
Before, immediately after and two months after intervention
Method of measurement
A standard questionnaire was summarized and Persian DOS (Form 21 questions

3

Description
Anxiety
Timepoint
Before, immediately after and two months after intervention
Method of measurement
A standard questionnaire was summarized and Persian DOS (Form 21 questions

4

Description
depration
Timepoint
Before, immediately after and two months after intervention
Method of measurement
A standard questionnaire was summarized and Persian DOS (Form 21 questions

Secondary outcomes

empty

Intervention groups

1

Description
Group test: the implementation of family-centered care program (first step: the perceived threat Step two: self-efficacy Upgrade Step Three: Self-Esteem Step Four: Evaluation) of caregivers of patients with epilepsy for four meeting two-hour , issues related to epilepsy, causes epilepsy, treatment, emergency of epilepsy,role of caregiver, sources of support, educational package includes a manual and CD, is provided by a steady group of neurologist doctors and nurses and psychiatric nursing. Before and after and two months after the intervention was completed questionnairesr
Category
Other

2

Description
Control group: no intervention on control group . questionnaires (before, after and two months after the intervention on intervention groups) are completed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani shahrekord Hospital/Neurological ward
Full name of responsible person
maryam heidari soureshjani
Street address
shahrekord
City
shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Shahrekord University of Medical Sciences
Full name of responsible person
Doctor Shahram Etemadifar
Street address
Street Kashani
City
ShahreKord
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,Shahrekord 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
shahrekord University of Medical Sciences
Full name of responsible person
maryam heidari soureshjani
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
shahrekord Street Kashani
City
shahrekord
Postal code
Phone
+98 383335654
Fax
Email
heidari93_m@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Medical Sciences shahrekord
Full name of responsible person
shahram eatamadifar
Position
nursing PH .D
Other areas of specialty/work
Street address
University of Medical Sciences
City
University of Medical Sciences Shahr e Kord
Postal code
Phone
+98 383335654
Fax
Email
sh_etemadifar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
maryam heidari
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Shahr e Kord
City
Shahr e Kord
Postal code
Phone
+98 38 3344 7394
Fax
Email
heidari93_m@yahoo.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
empty
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