1- Determination and comparison of stress among the elderly in the intervention group before and after training
2- Determination and comparison of stress among the elderly of the control group at the first and second stages of the assessment
3- Determining and comparing anxiety among the elderly of the intervention group before and after training
4- Determination and comparison of anxiety among the elderly of the control group at the first and second stages of the assessment
5- Determination and comparison of depression among the elderly of the intervention group before and after training
6- Determination and comparison of depression among the elderly of the control group at the first and second stages of the assessment
Design
A randomized clinical trial with a control group with a sample size of 60 people
Settings and conduct
The sample size in this study was 30 in each group. In this research, 30 elderly people living in Tohid nursing home were considered as an intervention group and 30 elderly people in the Farzanegan nursing home were considered as control group.
Participants/Inclusion and exclusion criteria
In this study, having a willingness to cooperate in the study, having full consciousness, having the vision, hearing and speaking ability , and satisfaction of families for the participation of the elderly were considered as criterions for entry and significant incidence of mental disorders and being in the chronic phase of lung disease as Non-entry criteria.
Intervention groups
In this study, the intervention included employee humor training, presented by the researcher. Humor training was conducted for 7 sessions of one and a half hours.
The control group did not receive an intervention.
Main outcome variables
Stress, anxiety, and depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190207042652N1
Registration date:2019-02-15, 1397/11/26
Registration timing:retrospective
Last update:2019-02-15, 1397/11/26
Update count:0
Registration date
2019-02-15, 1397/11/26
Registrant information
Name
Tannaz Taheri Gharagzlu
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8848 8065
Email address
t.taheri43@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-07-16, 1397/04/25
Actual recruitment start date
2018-06-05, 1397/03/15
Actual recruitment end date
2018-07-23, 1397/05/01
Trial completion date
2018-10-02, 1397/07/10
Scientific title
The effect of employees' humorous intervention on the severity of stress, anxiety, and depression among the elderly living in the nursing home
Public title
The effect of employees' humorous intervention on the severity of elderly`s stress, anxiety and depression in the
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a willingness to collaborate and participate in the study
Not having a significant incidence of mental disorders
Not being in the chronic stage of lung disease
Having full consciousness
Having vision, hearing and speaking ability
Satisfaction of and his/her familiy for the participation in the study
Exclusion criteria:
Unwillingness of the elderly or their families to continue cooperation after the start of the research
Elder's death or leaving the nursing home
Facing with acute pulmonary and cardiac problem during research
The onset of psychiatric medications affecting consciousness during the study period
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, samples were selected from two nursing homes. A total of 30 elderly residents in each nursing home were selected based on inclusion criteria. Then, randomly, the elderly of one of the nursing homes were considered as an intervention group and the other as a control group. In this regard, the name of each of the nursing homes was written on a piece of paper and placed in a dish. Then it was determined that the first extracted paper was the intervention group and the other paper the control group. By random extraction of the first paper, it was determined the intervention group and then the control group.
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 on Biomedical Research, Islamic Azad University, Faculty of Medicine
Before the intervention begins and immediately after it is completed
Method of measurement
Depression, Anxiety, Stress Scale (DASS)
2
Description
Anxiety
Timepoint
Before the intervention begins and immediately after it is completed
Method of measurement
Depression, Anxiety, Stress Scale (DASS)
3
Description
Depression
Timepoint
Before the intervention begins and immediately after it is completed
Method of measurement
Depression, Anxiety, Stress Scale (DASS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the intervention included the humor training which was presented by the researcher during 7 sessions of an hour and a half.
Category
Behavior
2
Description
Control group: The control group participants received no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid Nursing Home Complex
Full name of responsible person
Behrouz Hosseini
Street address
NO.137, Zahedi Alley, West Nosrat St, Tohid Sq, Tehran.
City
Tehran
Province
Tehran
Postal code
1457763181
Phone
+98 21 6694 2151
Email
Info@tohidsara.com
2
Recruitment center
Name of recruitment center
Farzanegan Nursing Home Complex
Full name of responsible person
Mojtaba Moazen
Street address
NO.11, Bahman pass way, Fifth St, Front of Laleh Hospital, Simaye-E- Iran St, Shahrak-e-Garb
City
Tehran
Province
Tehran
Postal code
1464213321
Phone
+98 21 8808 0304
Email
info@farzanegan.org.ir
Web page address
http://farzanegan.org.ir/contact
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mehrandokht Nekavand
Street address
Khaghani St, Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
mnakavand@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tannaz Taheri Gharagzlu
Position
Master of Sciences in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.1271, Tehran international residential tower, Hakim and Sheikh Bahaei intersection
City
Tehran
Province
Tehran
Postal code
14352224785
Phone
+98 21 8848 8065
Email
t.taheri43@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tannaz Taheri Gharagzlu
Position
Master of Sciences in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.1271, Tehran international residential tower, Hakim and Sheikh Bahaei intersection
City
Tehran
Province
Tehran
Postal code
14352224785
Phone
+98 21 8848 8065
Email
t.taheri43@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tannaz Taheri Gharagzlu
Position
Master of Sciences in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.1271, Tehran international residential tower, Hakim and Sheikh Bahaei intersection
City
Tehran
Province
Tehran
Postal code
14352224785
Phone
+98 21 8848 8065
Email
t.taheri43@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information are shareable after non-identifiable people
When the data will become available and for how long
Available in 2019
To whom data/document is available
Faculty members and academic researchers
Under which criteria data/document could be used
Scientific use with source mention
From where data/document is obtainable
Vice-chancellor for research of Islamic Azad University, Tehran Medical Branch
What processes are involved for a request to access data/document
Apply to the Vice-chancellor for research of Islamic Azad University, Tehran Medical Branch