Determining the effect of life review on the depression of elderly smoking men who referred to community health centers in Larestan city in 2024
Design
The study of a clinical trial study with control and intervention groups, parallel face, without blinding, randomized on 36 elderly male smokers.
Settings and conduct
The present study will be conducted on elderly smoking men referred to health centers in Larestan city
Participants/Inclusion and exclusion criteria
The samples have a voluntary desire to participate in the research.
Candidates should score 5 to 11 in the elderly depression questionnaire before the intervention. Candidates should have a history of smoking for at least 1 year.
The unwillingness of the samples to continue participating in the research is exclusion criterion.
Intervention groups
In this study, the life review protocol made by Haight and Webster, (1995) will be used. The intervention sessions will be conducted in 6 sessions (one session per week) as follow. in each group session, the topics will be discussed as described in the table below. In each session, the researcher reduces the resistance of the elderly with positive attention without judgment, active listening and the use of the emotion reflection technique, and by cognitive reconstruction of the wrong thoughts and views of the group members, renaming and positive interpretation of the negative aspects of their memories and also with emphasis On positive memories, it will help the integration of the person, reduce his despair and try to alleviate the depression of the elderly person.
Main outcome variables
Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090304001742N10
Registration date:2024-03-13, 1402/12/23
Registration timing:prospective
Last update:2024-03-13, 1402/12/23
Update count:0
Registration date
2024-03-13, 1402/12/23
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
2024-04-07, 1403/01/19
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of life review intervention on depression of elderly male cigarette smokers: a randomized controlled trial
Public title
The effect of life review intervention on depression of elderly male cigarette smokers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The samples should have a voluntary desire to participate in the research.
Candidates must be at least 60 years old.
Candidates should have acceptable hearing and speaking ability.
Volunteers should not suffer from cognitive diseases such as dementia.
Candidates should not have a history of using psychiatric drugs due to mental problems.
Candidates have not received treatment that interferes with mental ability, memory or thinking.
Candidates should be familiar with Persian language.
Candidates should score 5 to 11 on the elderly depression questionnaire before the intervention.
Candidates should have a normal cognitive state (get a score of 25 in the brief examination of mental state).
Volunteers should not be present in other treatment groups.
Volunteers should have a history of smoking for at least 1 year.
Exclusion criteria:
Occurrence of any severe social or family crisis during the study (such as bereavement of family members in the last 6 months)
Hospitalization or illness that interferes with conducting the research.
Taking nerve pills due to psychological problems during the study.
Occurrence of symptoms and signs of crisis when expressing and reviewing life events during the study.
Absence from meetings more than once.
Alcohol abuse and or drugs.
Unwillingness of the samples to continue participating in the research.
Age
From 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
At first, people were entered into the study through simple random sampling and using envelopes containing two numbers (1 and 2), according to a predetermined contract, if they pull out the number 1 from the envelope and meet the inclusion criteria. They will be. Then, according to the final sample size, which is 36 people, the randomized block method will be used to randomly assign people. So that 6 blocks of 6 cells will be considered for allocation. In each block, the sequence of cells will be set randomly. After determining the blocks and their sequences, using a dice, the initial block will be determined (for example, block 3) and people will be placed in the given sequence groups in the order of entering the study from block number 3. At the end, 18 people will be in the intervention group and 18 people will be in the control group. The sequence of blocks and the group related to each cell will be determined by the main researcher, and the assistant researcher who manages the random assignment and entry of people will not know about the sequences and the assignment of each person to the considered group. It seems that since the samples are randomly selected, the possibility of exchanging information between the intervention and control groups will be minimized.
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 Faculty of Medical Sciences
Street address
Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, North Karmandan St., Ghadir Blvd.
City
larestan
Province
Fars
Postal code
7431889629
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
IR.LARUMS.REC.1402.034
Health conditions studied
1
Description of health condition studied
Depression in elderly male smokers
ICD-10 code
Z13.3
ICD-10 code description
Special screening examination for mental and behavioural disorders
Primary outcomes
1
Description
Scores from 0 to 4 indicate normal, 5 to 8 mild depression, 9 to 11 moderate depression, and 12 to 15 severe depression.
Timepoint
Before the intervention, immediately after the intervention
Method of measurement
Elderly Depression Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the life review protocol made by Haight and Webster, (1995) will be used. The intervention sessions will be conducted in 6 sessions (one session per week) as follows. The approximate duration of each session will be about 1 hour. At first, after introducing the members and stating the objectives of the meetings, the researcher will try to create a friendly atmosphere and trust among the group members. Then, in each group session, the topics will be discussed as described in the table below. In each session, the researcher reduces the resistance of the elderly with positive attention without judgment, active listening and the use of the emotion reflection technique, and by cognitive reconstruction of the wrong thoughts and views of the group members, renaming and positive interpretation of the negative aspects of their memories and also with emphasis On positive memories, it will help the integration of the person, reduce his despair and try to alleviate the depression of the elderly person.
Category
Treatment - Other
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
Larestan
Province
Fars
Postal code
7431895639
Phone
+98 71 5224 7110
Email
mrbazr@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Mohammad-Rafi Bazrafshan
Street address
Larestan University of Medical Sciences, Behind Larestan Grand Bazaar, North Karmandan St., Ghadir Blvd.
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
mrbazr@sums.ac.ir
Grant name
larestan university of medical sciences
Grant code / Reference number
1402-173
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
Larestan University of Medical Sciences, Behind Larestan Grand Bazaar, North Karmandan St., Ghadir Blvd.
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
mrbazr@sums.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
Larestan University of Medical Sciences, Behind Larestan Grand Bazaar, North Karmandan St., Ghadir Blvd.
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
mrbazr@sums.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
Larestan University of Medical Sciences, Behind Larestan Grand Bazaar, North Karmandan St., Ghadir Blvd.
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
mrbazr@sums.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
Undecided - It is not yet known if there will be 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: mrbazr@sums.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