Determining the effect of reminiscing on anxiety caused by retirement syndrome in the elderly
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 88 patients. To control the effect of randomization, the samples of the control group come to the center on odd days of the week and the samples of the intervention group come to the center on even days of the week.
Settings and conduct
The place of performance is Babol Cultural Retirement Center.
For the purpose of blinding, sampling was done by an uninformed evaluator.
Participants/Inclusion and exclusion criteria
Entry criteria include:
At least six months have passed since retirement.
Age between 60-75 years
Having relative physical and mental health
Having acceptable hearing
Consent to participate in the study
Not having severe anxiety
Living with a spouse
Exit criteria:
Not participating in more than one reminiscence session
Severe family crisis
Intolerance of the group
Having mental illnesses
Lack of physical health
Intervention groups
This study is a clinical trial, randomized with a control group on the cultural retirees of the city
Babylon will be done. First, by referring to the center of cultural retirees with Rosh
Available sampling, then randomly assigning groups of people are divided into control and test groups.
Random sampling is done in the morning from Saturday to Wednesday. Beck, retirement syndrome and demographic questionnaires are filled by both control and intervention groups. The intervention group will undergo 6 reminiscence sessions and the control group will undergo routine care. After one month, Beck's questionnaire will be subjected to statistical intervention by two groups as a post-test.
Main outcome variables
Anxiety score in Beck's questionnaire
General information
Reason for update
Acronym
ERARS
IRCT registration information
IRCT registration number:IRCT20230702058642N1
Registration date:2024-01-08, 1402/10/18
Registration timing:registered_while_recruiting
Last update:2024-01-08, 1402/10/18
Update count:0
Registration date
2024-01-08, 1402/10/18
Registrant information
Name
Hadise Zamani Hamzekolai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 8807
Email address
hadis.zamani7697@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Reminiscence on the Anxiety caused by the retirement syndrome in elderly
Public title
The effect of Reminiscence on the anxiety caused by the retirement syndrome
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The elderly who have been retired for at least six months.
Their age should be between 60 and 75 years
In order to participate in the group, they must have an acceptable hearing according to the person's statements, regardless of physical health and mental health.
Consent to participate in the study.
Do not have severe anxiety (score 31 or higher in the Beck questionnaire).
Live with their wife
Exclusion criteria:
Those who do not participate in more than one reminiscence session.
Those who experience a severe family crisis during the study, such as the loss of a family member.
Those who do not have the ability to tolerate the group.
Those who suffer from mental and physical illnesses.
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be randomly assigned to one of two intervention or control groups based on a random list. To control the effect of randomization, the samples of the control group will come to the center on odd days of the week and the samples of the intervention group will come to the center on even days of the week.
Blinding (investigator's opinion)
Single blinded
Blinding description
An evaluator unaware of the method of intervention and the subject of the study evaluates and completes the questionnaire on Thursdays in order to comply with the conditions of blinding.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Meraj 21,Khurshidkala, Babol, Iran
City
babol
Province
Mazandaran
Postal code
4714745545
Approval date
2023-08-21, 1402/05/30
Ethics committee reference number
IR.SSU.REC.1402.045
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety score in Beck's questionnaire
Timepoint
At the beginning of the study, that is, before the start of the intervention and one month after the intervention
Method of measurement
Beck's anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:We consider 44 people randomly in the intervention group. We divide people into groups of 8 to 10 people. People in the intervention group fill out Beck's anxiety questionnaire as a pre-test. Then these people undergo 6 sessions of reminiscence intervention twice a week for forty-five to sixty minutes with the topics (members' introduction to each other + life events, family history, professional memories, experiences with stress, meaning and the meaning of life and summary) are placed. One month after the completion of the reminiscence sessions, Beck's anxiety questionnaire is completed as a post-test. Then the data is evaluated statistically.
Category
N/A
2
Description
Control group: We consider 44 people randomly in the control group. First, as a pre-test, people fill out Beck's anxiety questionnaire. People in the control group are subjected to routine care, including mental and physical games (chess, volleyball, soccer, Shahnameh reading, and music) of the center. One month after the end of the interventions, the Beck questionnaire will be completed as a post-test.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for cultural retirees of Babol
Full name of responsible person
Hadise zamani
Street address
Meraj19, Khorshid kola, Bagh ferdos, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4714745545
Phone
+98 11 3233 8807
Email
hadis.zamani7697@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Yazd University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, 15 Bo Ali Stree, Falahi Blvd, Yazd,Iran
City
yazd
Province
Yazd
Postal code
8916877441
Phone
+98 35 3824 1751
Email
hadis.zamani7697@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
hadise.zamani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Meraj 21,Khurshidkala, Babol, Iran
City
babol
Province
Mazandaran
Postal code
4714745545
Phone
+98 11 3233 8807
Email
hadis.zamani7697@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
hadise.zamani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Meraj 21,Khurshidkala, Babol, Iran
City
babol
Province
Mazandaran
Postal code
4714745545
Phone
+98 11 3233 8807
Email
hadis.zamani7697@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
hadise zamani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Meraj 21,Khurshidkala, Babol, Iran
City
babol
Province
Mazandaran
Postal code
4714745545
Phone
+98 11 3233 8807
Email
hadis.zamani7697@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Information about the main outcome or similar
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
For all members of society
Under which criteria data/document could be used
Helping the elderly with retirement syndrome if the results of this study are effective
From where data/document is obtainable
Refer to the website of Shahid Sadoughi University of Medical Sciences, Yazd
Request via email address: hadis.zamani7697@gmail.com
Contact number 09114126874
What processes are involved for a request to access data/document
Refer to the website of Shahid Sadoughi University of Medical Sciences, Yazd
Request via email address: hadis.zamani7697@gmail.com
Contact number 09114126874