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The Effectiveness of Structured Group Reminiscence Therapy on Depression and Anxiety of Elderly Women Smoking Hookah Referred to Larestan Community Health Centers, 2020

Protocol summary

Study aim
Determining the effectiveness of Structured Group Reminiscence Therapy on Depression and Anxiety of Elderly Women Smoking Hookah Referred to Larestan Community Health Centers, 2020
Design
Randomized clinical trial with control group, parallel groups without blindness, On 24 elderly women consuming hookah, followed for one month.
Settings and conduct
The present study will be performed on elderly women who smoke hookah and refer to health centers in Larestan city.
Participants/Inclusion and exclusion criteria
Samples tend to be voluntary to participate in research and before the intervention, the candidates obtained a score of 5 to 11 from the Elderly Depression Questionnaire, a score of 32 to 64 from the state Anxiety Test, and a score of 32 to 62 from the trait Anxiety Test.
Intervention groups
In this study, a Structured Group Reminiscence protocol will be used for the intervention group. In this program, twelve topics are discussed in 12 sessions (one to one and a half hours). 1. identification data. 2. Family photos, childhood playthings 3. Kids' chalkboard, chalk, school bag 4. Work tools and gadgets 5. Urban open space such as a park or community garden 6. Marriage 7. Home, garden and favorite animals 8. Next generation, infancy, and childhood period 9. Foods, cooking 10. Vacation, journeys 11. Celebration 12. Summarizing of sessions
Main outcome variables
After the intervention (for a month), The Elderly Depression , Spiel Berger Anxiety, and the MMSE Questionnaires are re-completed by participants.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090304001742N5
Registration date: 2020-08-10, 1399/05/20
Registration timing: registered_while_recruiting

Last update: 2020-08-10, 1399/05/20
Update count: 0
Registration date
2020-08-10, 1399/05/20
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
2020-07-22, 1399/05/01
Expected recruitment end date
2020-10-06, 1399/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Structured Group Reminiscence Therapy on Depression and Anxiety of Elderly Women Smoking Hookah Referred to Larestan Community Health Centers, 2020
Public title
The Effectiveness of Structured Group Reminiscence Therapy on Depression and Anxiety of Elderly Women Smoking Hookah
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Samples tend to be voluntary to participate in research. Candidates must be at least 60 years old. Candidates have acceptable listening and speaking skills. Candidates with acute psychosis do not have chronic and debilitating diseases and cognitive disorders such as dementia. Depression and anxiety are not the result of physical problems such as hypothyroidism. Candidates do not have a history of using psychiatric medications due to psychological problems. Candidates did not receive treatment that impaired mental ability, memory, or thinking. Candidates should be familiar with Persian language. Before the intervention, the candidates obtained a score of 5 to 11 from the Elderly Depression Questionnaire, a score of 32 to 64 from the state Anxiety Test, and a score of 32 to 62 from the trait Anxiety Test. Candidates should have a moderate level of cognitive status (obtaining a minimum score of 21 in the Mini-Mental State Examination test). Candidates should not be in other treatment groups. Candidates have a history of hookah use for at least 1 year.
Exclusion criteria:
Occurrence of any severe social, familial crisis during the study (such as the grief of family members in the last 6 months) Hospitalization or acute and chronic illness that interferes with research. Cognitive disorders and physical disabilities that seriously hinder participation in group therapy sessions. Taking psychiatric pills due to psychological problems during the study Symptoms and signs of crisis at the time of expression and review of life events during the study Absence from meetings more than once Alcohol or drug abuse Lack of willingness of samples to continue participating in research
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the fact that the final sample size is 24 people, the randomized blocks method will be used to allocate people equally to the intervention and control groups. Assisting the researcher By referring to the health centers of the selected community, at first, individuals enter the study through available sampling and according to the inclusion and exclusion criteria. The researcher will design 4 blocks of 6 (with 6 cells) according to the final sample size, which is 24 people. Then, people are referred in order and using random block method, they are placed in each of the block cells. It will pre-mark each cell with the letters A and B, and according to the pre-arranged contract, the people in house A will receive the intervention and the people in house B will become members of the control group. Finally, 12 people in the intervention group and 12 people in the control group will be randomly assigned.
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
Fars, Larestan, 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
Approval date
2020-04-27, 1399/02/08
Ethics committee reference number
IR.LARUMS.REC.1399.003

Health conditions studied

1

Description of health condition studied
Elderly women consuming hookah
ICD-10 code
Z72.0
ICD-10 code description
Tobacco use

Primary outcomes

1

Description
A score of 5 to 8 indicates mild depression, 9 to 11 indicates moderate depression, and 12 to 15 indicates severe depression.
Timepoint
Before the intervention, immediately and one month after the intervention
Method of measurement
Elderly Depression Questionnaire

2

Description
The scores on either of the trait and state anxiety scales can range from 20 to 80. state Anxiety: Rating 20 - 31 Mild Anxiety, Score 32 - 42 Medium to Low Anxiety, Rating 43 - 53 Medium to High Anxiety, Rating 54 - 64 Relatively Severe, Rating 65 - 75 Severe and Rating 76 and Up indicate High Anxiety It is severe. For trait Anxiety: Rating 20 - 31 Mild Anxiety, Rating 32 - 42 Medium to Low Anxiety, Rating 43 - 52 Medium to High Anxiety, Rating 53 - 62 Relatively Severe Anxiety, Rating 63 - 72 Severe Anxiety, Rating 73 and Up Very Anxiety Shows extreme.
Timepoint
Before the intervention, immediately and one month after the intervention
Method of measurement
Spiel Berger Anxiety Questionnaire

Secondary outcomes

empty

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
Treatment - Other

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
Larestan
Province
Fars
Postal code
7431895639
Phone
+98 71 5224 7110
Fax
+98 71 5224 7111
Email
mrbazr@sums.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
mrbazr@sums.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
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
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
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
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
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
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