Determine the effect of participating in support groups on relocation stress syndrome in residents of nursing homes
Design
Randomized clinical trial with control group, community and practical based, parallel groups, blinded outcome assessment, randomized
Settings and conduct
The study environment is Kahrizak nursing home. The research community is the elderly living in the Kahrizak nursing home who will be selected based on entry criteria. A researcher-made demographic information questionnaire, and Depression, anxiety and loneliness questionnaires, will be completed for both groups at the beginning of the study. Support group meetings for the intervention group will be held for 6 sessions and each session will be held for 1 hour and 2 times a week. After 4 weeks from the last support group meeting, the questionnaires are completed again. At the end, the tools for the control group will also be completed, then the results will be compared.
Participants/Inclusion and exclusion criteria
Entry requirements:
1.Duration of stay up to 1 year
2. No cognitive disorder
3. Ability for visual and verbal communication
4.No mood disorders.
No entry condition:
1.Unwillingness to continue participating in the study
2.Lack of participation at support group meetings in 2 sessions
3.Beginning of the cognitive disorder during the study
4. An important incident (such as divorce, death of loved ones, financial bankruptcy ...) during the last year
Intervention groups
There is an intervention group and a control group. At first, the required explanations for the research are given to the samples and informed consent will be obtained. In this study, the final sample size will be 30 people per group and a total of 60 people. The intervention group will attend the support group meetings.
Main outcome variables
Depression
Anxiety
Loneliness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170812035647N3
Registration date:2018-07-16, 1397/04/25
Registration timing:registered_while_recruiting
Last update:2018-07-16, 1397/04/25
Update count:0
Registration date
2018-07-16, 1397/04/25
Registrant information
Name
Sarieh Poortaghi
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4209
Email address
s-poortaghi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-21, 1397/03/31
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of participating in support groups on relocation stress syndrome( RSS) in residents of nursing homes
Public title
Effect of support groups on relocation stress syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The elderly living in a nursing home whose length of stay at that center is at most 1 year
There is no recognized cognitive impairment (such as Alzheimer's, dementia, delirium, etc.)
Being able to communicate verbally and eye contact
There is no history of mood disorders based on expert diagnosis
Exclusion criteria:
Unwillingness to continue participating in the study
Non-attendance at support group meetings in 2 sessions
Beginning of the cognitive disorder during the study
In one year, an important incident (such as divorce, death of loved ones, financial bankruptcy ...) has occurred in life
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the prototype, individuals will be assigned to the intervention and control groups based on the case number and using the random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
To collect data from a research collaborator using unknowing type groups
Also, the statistics specialist and participants in the research will also be unaware
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
•Ethics Committee of Tehran University of Medical Sciences
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences,Nosrat st. Tohid sq. Tehran I.IRAN 141973317
City
Tehran
Province
Tehran
Postal code
141973317
Approval date
2017-11-03, 1396/08/12
Ethics committee reference number
IR.TUMS.FNM.REC.1396.3870
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
2
Description of health condition studied
Anxiety Disorders
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Depression
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Geriatric depression scale
2
Description
Anxiety
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Geriatric anxiety scale
3
Description
Loneliness
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
University of California at Los Angeles loneliness scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Desired tools included researcher-made demographic questionnaire and geriatric depression scale(GDS), geriatric anxiety scale(GAS) And the shortened form of UCLA (ULS) University of California, Los Angeles ، will be completed at the beginning of the study for both groups. The support groups will hold for 6 sessions and each session for 1 hour and 2 times a week.The first session will focus on the familiarization and expression of goals. At the next sessions, according to the goals, the researcher will initially provide the group members with information on each of the topics discussed, including depression, anxiety and loneliness.Then the people in the group will share their experiences and individual ways of dealing with it ,In the meantime, the researcher addresses the problems raised during the meeting, while the elderly are discussing and discussing emotional support among each other, to provide scientific and practical solutions And uses the experience of a successful counterpart in relation to the subject. After 4 weeks from the last support group meeting, the questionnaires are completed again. At the end, the tools for the control group will be completed and the results will be compared.
Category
Lifestyle
2
Description
Control group: Depression, anxiety and loneliness questionnaires will be completed before the beginning of the study for the control group. During the study, the group will not receive intervention. After the end of the intervention in the intervention group, the questionnaires will be completed again for the control group and then the results will be compared.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kahrizak Charity Foundation
Full name of responsible person
Dr Mohammadreza Hakimzadeh
Street address
Dr. Hakim Zade Blvd,end of Kahrizak,after Behesht Zahra,Qom old road ,Kahrizak,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1575633411
Phone
+98 21 5652 5804
Fax
+98 21 8834 5620
Email
info@kahrizak.com
Web page address
http://kahrizak.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Deputy of Research of Tehran University of Medical Sciences
Street address
Deputy of Research ,Central Organization of the University,Corner of Quds Street,Keshavarz Blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Fax
+98 21 8163 3623
Email
rmo@tums.ac.ir
Web page address
https://www.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Seyedeh Sahar Ghaderi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences,Nosrat St. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21066922700
Email
Saharghaderi90@yahoo.com
Web page address
Https://www.Tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyedeh Sahar Ghaderi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences,Nosrat St. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21066922700
Email
Saharghaderi90@yahoo.com
Web page address
Https://www.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyedeh Sahar Ghaderi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences,Nosrat St. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21066922700
Email
Saharghaderi90@yahoo.com
Web page address
Https://www.tums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available