Protocol summary

Study aim
Determining the effect of Group Reminiscence Therapy on adaptation to aging and death anxiety
Design
Clinical Trial with community based and control group, with parallel groups without blindness, Not Randomized, followed for one month
Settings and conduct
This study is conducted in elderly peoples with death anxiety and difficulty adaptation to old age referred to health center of Lar city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Samples have a willingness to participate in the research. 2. The candidates are at least 60 years of age. 3. Volunteers are not with acute psychosis, chronic and debilitating illnesses and cognitive diseases such as dementia. 4. anxiety disorder are not due to physical problems such as hypothyroidism. 5. Volunteers are familiar with Persian language. Exclusion criteria: 1. The occurrence of any severe social, familial crises during the study 2. The use of psychiatric pills due to psychological problems during the study. 3. Absence in meetings more than once. 4. Abuse of alcohol or drugs.
Intervention groups
In this study, 12 sessions of Group Reminiscence Therapy will be held for 16 members of the intervention group, while the control group will not receive any intervention.
Main outcome variables
death anxiety, adaptation with elderly

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090304001742N7
Registration date: 2020-08-26, 1399/06/05
Registration timing: registered_while_recruiting

Last update: 2020-08-26, 1399/06/05
Update count: 0
Registration date
2020-08-26, 1399/06/05
Registrant information
Name
mohammadrafi bazrafshan
Name of organization / entity
shiraz university medical science
Country
Iran (Islamic Republic of)
Phone
+98 917 382 1959
Email address
mrbazr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of structured group reminiscence on death anxiety and adaptation to old age
Public title
The Effect of Group Reminiscence Therapy on Death Anxiety and the Adaptation of Elderly to Old Age among the Elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Samples have a voluntary tendency to participate in research Candidates must be over 60 years of age Candidates do not have acute psychosis, chronic and disabling diseases, and cognitive disorders such as dementia. they have also not recently received similar treatment Physical problems such as hypothyroidism have not led to anxiety disorders Persian language
Exclusion criteria:
Occurrence of any social, familial crisis during the study Hospitalization or acute and chronic illness that interferes with research. Absence from meetings more than once Lack of willingness of samples to continue participating in research
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
The study is non-randomized.
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 of Larestan University of Medical Sciences
Street address
Lar - New City - North Ghadir Boulevard - Karmandan Street - Behind the Grand Bazaar of Larestan - Sina Building
City
Larestan
Province
Fars
Postal code
7431889629
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.LARUMS.REC.1398.028

Health conditions studied

1

Description of health condition studied
Elderly
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
death anxiety
Timepoint
Before the intervention, immediately and one month after the intervention
Method of measurement
Death Anxiety Questionnaire

Secondary outcomes

1

Description
adaptation to old age
Timepoint
Before the intervention, immediately and one month after the intervention
Method of measurement
Assessment Scale of Adaptation Difficulty for the Elderly

Intervention groups

1

Description
Intervention group: Receiving 8 sessions of structured group reminiscence therapy. In this program, twelve topics are discussed in 12 sessions (one to one and a half hours). In each of these sessions, stimuli are used to recall memories related to the topic of the session, which, depending on the topic of the session, may include photos, work tools, childhood toys, and so on. The protocol in this study will be implemented by the researchers themselves.In the present study, some sessions will be merged and the protocol will be reduced to 8 sessions (integration of sessions 1 and 2, 4 and 5, 9 and 10, 11 and 12).In order to record the course of changes in grades, participants will be asked to complete the questionnaires one month after the intervention in the pre-test stage, immediately after the intervention.
Category
Behavior

2

Description
Control group: They do not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Larestan Health Center
Full name of responsible person
Mohammad-Rafi Bazrafshan
Street address
Dr. Dadman Highway
City
لارستان
Province
Fars
Postal code
7431895639
Phone
+98 71 5224 7110
Fax
+98 71 5224 7111
Email
m.bazrafshan@larums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Karimi
Street address
New City, North Ghadir Blvd., Karmandan St., Behind Larestan Grand Bazaar, Sina Building (Larestan University of Medical Sciences)
City
larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
m.bazrafshan@larums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Larestan 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
Larestan University of Medical Sciences
Full name of responsible person
Mohammad-Rafi Bazrafshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
New City, North Ghadir Blvd., Karmandan St., Behind Larestan Grand Bazaar, Sina Building (Larestan University of Medical Sciences)
City
larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
m.bazrafshan@larums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Mohammad-Rafi Bazrafshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
New City, North Ghadir Blvd., Karmandan St., Behind Larestan Grand Bazaar, Sina Building (Larestan University of Medical Sciences)
City
larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
m.bazrafshan@larums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Mohammad-Rafi Bazrafshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
New City, North Ghadir Blvd., Karmandan St., Behind Larestan Grand Bazaar, Sina Building (Larestan University of Medical Sciences)
City
larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
m.bazrafshan@larums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
It can be shared by unidentifiable participants
When the data will become available and for how long
Access begins a year after the publication of results
To whom data/document is available
People who are working in the academic and scientific institutions
Under which criteria data/document could be used
It needs the agreement of Larestan University of Medical Sciences
From where data/document is obtainable
Dr. Mohammad Rafi Bazrafshan, Associate Professor, Larestan University of Medical Sciences, e-mail address: m.bazrafshan@larums.ac.ir, Contact Phone: 07152247110, Mobile Number: 09173821959
What processes are involved for a request to access data/document
Written and formal request to the vice chancellor for research of Larestan University of Medical Sciences
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