Objective: This study will be done to evaluate the effect of informational support on the satisfaction and anxiety of family caregivers of patients with hemiplegic stroke. Design: This study is a quasi-experimental clinical trial with two groups (intervention and control) and pre-test - post-test design. Setting and conduct: This study will be done by participating 84 family caregivers of stroke hemiplegic patients admitted to hospital neurology Farshchian (Sina) in Hamadan. Each group consists of 42 patient’s people. Participants, including major eligibility criteria: The family member is responsible for the patient care; minimum age of 18 years; ability to read and write; lack of neurological disease, mental illness and anxiety; lack of drugs and psychotropic substance abuse; lack of communication problems; Be able to speak and understand the language of Farsi; unemployment in health centers. Exclusion criteria: Don't have willingness family caregivers to continue to study at any moment; death of the patient; family member cannot participate in all educational sessions; creating unwanted problems for the patient, such as re-bleeding and severe hemodynamic disorders that affect on the family. Intervention: In experimental group, family caregivers will receive some informational support that is consist of introductory neurology ward tour, training sessions and educational booklet and pamphlet about matters related to stroke. No intervention will be done in control group. In both groups will be measure level of anxiety by Spielberger questionnaire and family caregiver’s satisfaction by satisfaction of information questionnaire before and after the intervention. Main outcome measure: The main outcome is the anxiety and satisfaction of information on family caregivers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022032129N2
Registration date:2017-04-21, 1396/02/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Azim Azizi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
a.azizi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Expected recruitment start date
2017-04-09, 1396/01/20
Expected recruitment end date
2017-09-11, 1396/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of informational support on anxiety and satisfaction of family caregivers of patients with hemiplegic stroke
Public title
The effect of informational support on anxiety and satisfaction of family caregivers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The family member is responsible for the patient care; minimum age of 18 years; ability to read and write; lack of neurological disease, mental illness and anxiety; lack of drugs and psychotropic substance abuse; lack of communication problems; Be able to speak and understand the language of Farsi; unemployment in health centers. Exclusion criteria: Don't have willingness family caregivers to continue to study at any moment; death of the patient; family member cannot participate in all educational sessions; creating unwanted problems for the patient, such as re-bleeding and severe hemodynamic disorders that affect on the family.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Not 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
Ethics Committee of Hamedan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmide boulevard, Hamadan
City
Hamadan
Postal code
009881338380717
Approval date
2017-01-20, 1395/11/01
Ethics committee reference number
IR.UMSHA.REC.1395.529
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
The anxiety in caregivers of patients with stroke
Timepoint
8 days before and after the intervention.
Method of measurement
Anxiety Inventory (STAI)
2
Description
satisfaction of information
Timepoint
8 days before and after the intervention
Method of measurement
satisfaction of information questionnaire
Secondary outcomes
1
Description
The satisfaction of caregivers of patients with stroke
Timepoint
8 days before and after the intervention.
Method of measurement
Family caregivers satisfaction
Intervention groups
1
Description
The intervention study was conducted in two phases the first phase information support family caregivers for individual training, oral and face-to-face patient care to the patients and their relatives were tailored to the needs.The second stage consists of two one-hour group training session focused on the overall needs of patients with stroke and their carers group discussion about the problems and concerns as every other day will be held. The manual includes general information about stroke, its cause, explanation about the different aspects of treatment, including surgery, adverse events, patient's diet, the symptoms and how to prevent it, how to deal with disabilities
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Educational and Medical Center
Full name of responsible person
Zhaleh Mollaei
Street address
Mirzadeheshghi St. Farshchian Educational and Medical Center
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences, Vice chancellor for Research
Full name of responsible person
Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmide boulevard, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences, Vice chancellor for Research
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
Hamadan University of Medical Sciences
Full name of responsible person
Azim Azizi
Position
PhD in Nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Science, Shahid Fahmide boulvard, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 0150
Fax
Email
a.azizi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Azim Azizi
Position
PhD in Nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Science, Shahid Fahmide boulvard, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 0150
Fax
Email
a.azizi@umsh.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Azim Azizi
Position
PhD in nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 0150
Fax
Email
a.azizi@umsh.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)