Comparing the effect of group reminiscence therapy on loneliness and spiritual well-being of elderly men with MS
Design
Clinical trials with control group (assigning groups to intervention and control in a simple random method)
Settings and conduct
This study will be conducted in Kahrizak nursing homes in Tehran, group- reminiscence therapy based will be held in groups of 6-5 people for 3 weeks and 2 times each week.
Participants/Inclusion and exclusion criteria
Inclusion criteria
At least 6 months staying at the nursing home; Persian language; Multiple Sclerosis diseases
exclusion criteria
Comorbidities of severe mental illness according to records; Experience of stressful events in the last 3 months (the loss of a spouse or other loved ones); History of attend to reminiscence therapy sessions previous or at the same; Severe hearing loss; Serious communication barrier
Intervention groups
6 sessions of group reminiscence therapy according to the Watts-Kpleys protocol are performed as follows,
ّّFirst session: the crises event of life
Second session :family history
Third session: job or major activity in life and personal interest
Fourth session : stressful life experiences
Fifth session : Review of love and hate in life
Sixth session: The meaning and the purpose of life
Control group: Daily life activities.
Main outcome variables
The state of spiritual health and loneliness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170411033378N5
Registration date:2018-11-24, 1397/09/03
Registration timing:retrospective
Last update:2018-11-24, 1397/09/03
Update count:0
Registration date
2018-11-24, 1397/09/03
Registrant information
Name
Efat Sadeghian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
sadeghian_e@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect groups reminiscence therapy on loneliness and spiritual well- being among elderly men with Multiple sclerosis
Public title
Comparing the effect of groups reminiscence therapy on loneliness and spiritual well-being of elderly men
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men aged 65 to 89 years
At least 6 months staying at the nursing home,
Persian language
Multiple Sclerosis diseases
Exclusion criteria:
Comorbidities of severe mental illness according to records
Experience of stressful events in the last 3 months (the loss of a spouse or other loved ones)
History of attend to reminiscence therapy sessions previous or at the same
Severe hearing loss
Serious communication barrier
Age
From 60 years old
Gender
Male
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study is simple random.Tools used in randomization is table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical
Street address
In front of Mardom Park, Hamedan University of Medical Sciences,
City
hamadan
Province
Hamadan
Postal code
38698 -65178
Approval date
2018-06-09, 1397/03/19
Ethics committee reference number
IR.UMSHA.REC.1397.139
Health conditions studied
1
Description of health condition studied
multiple scloresis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
loneliness
Timepoint
before and after of intervention
Method of measurement
Russell's loneliness questionnaire
Secondary outcomes
1
Description
spiritual well- being
Timepoint
before and after of intervention
Method of measurement
spiritual well-being questionnaire Palutzin and Waalson
Intervention groups
1
Description
6 sessions of group reminiscence therapy according to the Watts-Kpleys protocol are performed as follows, First session: the crises event of life Second session :family history Third session: job or major activity in life and personal interest Fourth session : stressful life experiences Fifth session : Review of love and hate in life Sixth session: The meaning and the purpose of life.
Category
Rehabilitation
2
Description
Control group: Daily life activities
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Kahrizak nursing home
Full name of responsible person
Efat Sadeghian
Street address
Shahid Fahmide boulvar, park mardom street
City
hamadan
Province
Hamadan
Postal code
65178-38698
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Research and Technology Vice-Chancellor
Street address
In front of Mardom Park, Hamedan University of Medical Sciences
City
hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0717
Email
bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
In front of Mardom Park, Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
In front of Mardom Park, Hamedan University of Medical Sciences
City
hamadan
Province
Hamadan
Postal code
65178-38698
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
In front of Mardom Park, Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
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
The whole data will be published after the unidentifiable individuals are shared, which will be published as the final report and article
When the data will become available and for how long
Starting available 6 months after the publication of results
To whom data/document is available
Researchers working in academia and those working in the industry can apply for them.
Under which criteria data/document could be used
Anyone who wishes to use the articles to be retrieved is possible with email.
From where data/document is obtainable
by Email address
What processes are involved for a request to access data/document