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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: IRCT
Last refreshed on: 22 February 2018
Main ID:  IRCT2017022032129N2
Date of registration: 2017-04-21
Prospective Registration: No
Primary sponsor: Hamadan University of Medical Sciences, Vice chancellor for Research
Public title: The effect of informational support on anxiety and satisfaction of family caregivers
Scientific title: The effect of informational support on anxiety and satisfaction of family caregivers of patients with hemiplegic stroke
Date of first enrolment: 2017-04-09
Target sample size: 84
Recruitment status: Complete
URL:  http://en.irct.ir/trial/25112
Study type:  interventional
Study design:  Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.  
Phase:  N/A
Countries of recruitment
Iran (Islamic Republic of)
Contacts
Name: Azim Azizi   
Address:  Hamadan University of Medical Science, Shahid Fahmide boulvard, Hamadan Hamadan Iran (Islamic Republic of)
Telephone: +98 81 3838 0150
Email: a.azizi@umsha.ac.ir
Affiliation:  Hamadan University of Medical Sciences
Name: Azim Azizi   
Address:  Hamadan University of Medical Science, Shahid Fahmide boulvard, Hamadan Hamadan Iran (Islamic Republic of)
Telephone: +98 81 3838 0150
Email: a.azizi@umsh.ac.ir
Affiliation:  Hamadan University of Medical Sciences
Key inclusion & exclusion criteria
Inclusion 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.
Exclusion criteria:

Age minimum: no limit
Age maximum: no limit
Gender: Both
Health Condition(s) or Problem(s) studied
Cerebellar stroke syndrome
stroke.
Cerebellar stroke syndrome
Intervention(s)
Prevention
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.
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
Primary Outcome(s)
Satisfaction of information. Timepoint: 8 days before and after the intervention. Method of measurement: satisfaction of information questionnaire.
The anxiety in caregivers of patients with stroke. Timepoint: 8 days before and after the intervention. Method of measurement: Anxiety Inventory (STAI).
Secondary Outcome(s)
The satisfaction of caregivers of patients with stroke. Timepoint: 8 days before and after the intervention. Method of measurement: Family caregivers satisfaction.
Secondary ID(s)
Source(s) of Monetary Support
Hamadan University of Medical Sciences, Vice chancellor for Research
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Ethics Committee of Hamedan University of Medical Sciences
Results
Results available:
Date Posted:
Date Completed:
URL:
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