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Effect of family oriented communication skills education on depression, anxiety and stress, and quality of life in older adults and their main care givers

Protocol summary

Summary
Long life has been known as one of the positive outcomes of social development only if more attention is paid to quality of life (QOL) and health. One of the important domains of geriatric health is its psychological dimension , which needs specific attention. An older adult should cope with sorrow of numerous losses, changes in their occupational status , and a reduction in their physical ability and health. In addition to the aforementioned risk factors, changes in sensory system ( auditory and visual abilities) can also influence older adults’ mental health and communicational skills. Meanwhile , social dimension of life has a high impact on health and QOL . Communicational skills are one of the predicting factors of mental health and one of the factors influencing depression , anxiety and stress. With regard to the effect of communicational skills on mental health and as education of these skills and family participation have not been much respected , conducting such a study seems essential. This study is a clinical trial to determine effect of family oriented communication skills education on depression , anxiety and stress , and quality of life in older adults and their main care givers with absence of older adults’ and their main caregivers’ physical and mental disability, no recent older adults’ and their main caregivers’ consumption or history of anti depression, anti anxiety, and anti stress medications referring to health care centers in Isfahan field two-group three- stage with sample size 120 subjects in study and control groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014110114463N4
Registration date: 2014-11-28, 1393/09/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-28, 1393/09/07
Registrant information
Name
Zahra Ghazavi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7580
Email address
zahra_ghazavi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-09-11, 1393/06/20
Expected recruitment end date
2014-11-26, 1393/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of family oriented communication skills education on depression, anxiety and stress, and quality of life in older adults and their main care givers
Public title
Effect of family oriented communication skills education on depression, anxiety and stress, and quality of life in older adults and their main care givers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Older adults’ and their main caregivers’ least literacy of reading and writing; Older adults’ and their main caregivers’ signed consent form; Older adults’ and their main caregivers’ full consciousness; Older adults’ and their main caregivers’ familiarity with Persian language; Older adults’ age of 60 years or over; Absence of older adults’ and their main caregivers’ physical and mental disability; No recent older adults’ and their main caregivers’ consumption or history of anti depression , anti anxiety , and anti stress medications; No history of psychiatric disorders based on a psychiatrist’s diagnosis in the older adults and their main caregivers; No involvement in a disturbing disease that directly causes a behavioral disorder in older adults and their main caregivers Exclusion criteria: Start of medications to control psychiatric signs with a physician’s order during the study for the older adults or their main caregivers; Older adults’ and their main caregivers’ loss of interest to continue with the study at any stage ; Older adults’ or their main caregivers’ deat; Absenteeism for more than two sessions
Age
From 33 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Esfahan
Postal code
Approval date
2014-08-24, 1393/06/02
Ethics committee reference number
393333

Health conditions studied

1

Description of health condition studied
Mental and behavioural disorders
ICD-10 code
F32
ICD-10 code description
Depressive episode

2

Description of health condition studied
Mental and behavioural disorders
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

Primary outcomes

1

Description
Anexiety
Timepoint
Before the intervention, Immediately after the intervention, One month after the intervention
Method of measurement
Questionnaire

2

Description
Depression
Timepoint
Before the intervention, Immediately after the intervention, One month after the intervention
Method of measurement
Questionnaire

3

Description
stress
Timepoint
Before the intervention, Immediately after the intervention, One month after the intervention
Method of measurement
Questionnaire

4

Description
Quality of life
Timepoint
Before the intervention, Immediately after the intervention, One month after the intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
After selection of an adequate number of subjects, educational program will be administrated in form of six 45-minute sessions once a week in study group .Intervention will start with an introduction and familiarization with the general design of work and primary concepts . Then, the subjects will educate about the lack of communication skills outcomes, familiarization with skills of active listening and asking questions, familiarization with body language skill, melody and tone of voice and skill of touch, familiarization with the effect of sympathy on reduction of loneliness, and anger control, familiarization with needed communication skills among the older adults involved in elderly problems (reduction of hearing and visual abilities, and reduction of memory). At the end of the sixth session Depression, Anxiety, Stress Scale 21 (DASS 21) and Lipad’s Quality of Life Questionnaire among the elderly as well as WHOQOL questionnaires will be completed. Finally, to investigate the longevity of treatment, Depression, Anxiety , Stress Scale 21 (DASS 21) and Lipad’s Quality of Life Questionnaire among the elderly as well as WHOQOL questionnaires will be completed for the third time in study group.
Category
Behavior

2

Description
In control group, two sessions will be held in which the subjects conducte group discussion about their favorite subjects.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
25 Dastgerd health Care center
Full name of responsible person
Hoseini Habib o....
Street address
Dastgerd Ave.
City
Esfahan

2

Recruitment center
Name of recruitment center
َAli Hazrat health Care center
Full name of responsible person
Ghasemi Morteza
Street address
metri 24 Ave.
City
Esfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Taleghani Fariba
Street address
Nursing& Midvifery Faculty, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Esfahan
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
Nursing Faculty, Isfahan University of Medical Sciences
Full name of responsible person
1-Ghazavi Zahra 2-Feshangchi Simin
Position
1-Academic Member/ Master of Science, 2-Student/ Master of Science
Other areas of specialty/work
Street address
Psychiatric Nursing Dep.Nursing & Midvifery Faculty, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Esfahan
Postal code
8174673461
Phone
+98 31 3792 2960
Fax
+98 31 3669 9398
Email
zahra_ghazavi@nm.mui.ac.ir & s.feshangchi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ghazavi Zahra
Position
Academic Member/ Master of Science
Other areas of specialty/work
Street address
Psychiatric Nursing Dep, Nursing and Midvifery Faculty, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Esfahan
Postal code
8174673461
Phone
+98 31 3792 2960
Fax
+98 31 3669 9398
Email
zahra_ghazavi@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ghazavi Zahra
Position
Academic Member/ Master of Science
Other areas of specialty/work
Street address
Psychiatric Nursing Dep, Nursing and Midvifery Faculty, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Esfahan
Postal code
8174673461
Phone
+98 31 3792 2960
Fax
+98 31 3669 9398
Email
zahra_ghazavi@nm.mui.ac.ir
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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