Protocol summary

Summary
This study will aim to evaluate the effect of empathy on the promotion of social health in the elderly. Design: This Clinical Trial study will be conducted in 2017 on 70 referring to the association of elderly. The sampling will be conducted using available sampling that have the inclusion criteria will be considered as the samples and then who are selected will be divided into two groups. Inclusion criteria of this research includes: age 60 and older, there are no Alzheimer's disease or other mental illness, ability to communicate, consent to participate in the study, ability to complete the questionnaire, ability to participate in intervention session, there are no any crisis during the past six months and during this study. Exclusion criteria of this research includes:: every one will die or be hospitalized during this study, acute stress, such as the death of relatives and family members, change location during this study, absence of more than 2 sessions of our session. Method: The applied tool will be the Keyes Social Health Questionnaire in three periods: before the intervention, immediately after and one month after treatment our intervention will be completed. Intervention will be containing: elderly in participle groups will attend to 8 sessions promote empathy and who in control group will attend to 3 sessions with content will be organized by researcher. Main outcome measures: The results of this study will evaluate the effect of empathy on the promotion of social health in the elderly.

General information

Acronym
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IRCT registration information
IRCT registration number: IRCT2016090329674N1
Registration date: 2016-11-03, 1395/08/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-03, 1395/08/13
Registrant information
Name
Akram Rismanchian
Name of organization / entity
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery
Country
Iran (Islamic Republic of)
Phone
+98 31 3630 4826
Email address
a.rismanchian@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2016-06-30, 1395/04/10
Expected recruitment end date
2016-07-31, 1395/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of empathy improvement program on social health of elders
Public title
Investigating the effect of empathy improvement program on social health of elders reffered to aging association of isfahan province 2016
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 60 and older؛ lack of Alzheimer's disease or other mental illness؛ ability to communicate؛ consent to participate in the study؛ the ability to complete the questionnaire؛ the ability to participate in intervention session؛ lack of crisis during the past six months and during the study. Exclusion criteria of the study: Unwillingness to cooperate؛ elder die or be hospitalized؛ acute stress؛ such as the death of relatives and family members change location during the study؛ absence of more than 2 sessions.
Age
From 60 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sealed envelope method

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery
Street address
Isfaha University Of Medical Sciences Faculty Of Nursing and Midwiery , Hezar Jreb avenue , Isfahan
City
Isfahan
Postal code
81746-73461
Approval date
2016-06-28, 1395/04/08
Ethics committee reference number
ir.mui.rec.1395.3.163

Health conditions studied

1

Description of health condition studied
Social Health
ICD-10 code
--
ICD-10 code description
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Primary outcomes

1

Description
Social Health
Timepoint
Before , immediately after and one month later
Method of measurement
Keyes social well-being scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Run 8 group sessions with educational and promote empathy content
Category
Behavior

2

Description
Control group: Run 4 sessions with the content of old age problems
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Aging Association of Isfahan province
Full name of responsible person
Mortaza Rismanchian
Street address
Aging Association of Isfahan province, Abshar avenue, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research , Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mehdi Nemat Bakhsh
Street address
Isfahan,St.Hezar Jerib,University of Medical Sciences
City
Isfahan
Grant name
395163
Grant code / Reference number
395163
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research , 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 Faculty Of Nursing and Midwiery
Full name of responsible person
Akram Rismanchian
Position
MSC student of nursing
Other areas of specialty/work
Street address
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery , Hezar Jreb avenue , Isfahan , Iran
City
Isfahan
Postal code
8174673461
Phone
+98 31 3630 4826
Fax
Email
a.rismanchian@khuisf.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery
Full name of responsible person
Jahangir Maghsoudi
Position
Phd of nursing
Other areas of specialty/work
Street address
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery , Hezar Jreb avenue , Isfahan , Iran
City
Isfahan
Postal code
Phone
+98 31 3792 7525
Fax
Email
a.rismanchian@khuisf.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery
Full name of responsible person
Akram Rismanchian
Position
MSC student of nursing
Other areas of specialty/work
Street address
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery, Hezar Jreb avenue, Isfahan, Iran
City
Isfahan
Postal code
8818613471
Phone
+98 31 3630 4826
Fax
Email
a.rismanchian@khuisf.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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