The efficacy of group logotherapy based on Frankl school on depression and life expectancy in patients with gastrointestinal cancer referred to Omid Hospital in Urmia, 2022
Design
A clinical trial with a control group, without blinding, randomized on fifty patients, cards with numbers 1 or 2 were used for randomization.
Settings and conduct
In this study, 50 patients with gastrointestinal cancer referred to Omid Urmia Hospital were selected based on the inclusion and exclusion criteria of the study and were randomly assigned to intervention and control groups using cards. will get For people in the intervention group, 10 group logotherapy sessions will be held daily except Thursday and Friday for 60-90 minutes. Beck's depression and Schneider's life expectancy questionnaires will be completed in this study.
Participants/Inclusion and exclusion criteria
Entry requirements:
Being 20-60 years old
Have a minimum literacy
Having Information on the type of disease
Having the ability to perform activities independently
Having a proper physical condition
Lack of experience in critical situations in the last six months
Not being on stage 4 disease
Having a cell phone
Having basic information about cyberspace
Consent to participate in the study
A score of 5 or higher on the Beck Depression Inventory
A score of 36 or lower on the Schneider Life expectancy questionnaire
No entry conditions:
Withdrawal from attending meetings
Deterioration of physical condition
Occurrence of a critical accident during the study
Absence from more than one meeting
See a psychiatrist or psychologist while studying
Intervention groups
There will be no intervention for the control group, but the intervention group will participate in ten group logotherapy sessions. Both of the groups will receive the routine interventions of the hospital.
Main outcome variables
Depression , life expectancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220507054762N1
Registration date:2022-08-09, 1401/05/18
Registration timing:prospective
Last update:2022-08-09, 1401/05/18
Update count:0
Registration date
2022-08-09, 1401/05/18
Registrant information
Name
Laia Rezapour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3347 0678
Email address
rezapourlaia331@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of group logotherapy based on Frankl school on depression and life expectancy in patients with gastrointestinal cancer
Public title
The efficacy of group logotherapy on depression and life expectancy in patients with gastrointestinal cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-60 years
Having a minimum literacy
Knowledge of the type of disease
Having the ability to perform personal and simple activities independently
Having a physical condition so that he can participate in meetings
Having no experience of accidents and critical situations in the last six months
Not being on stage 4 of the disease
Having a mobile phone
Having basic information about cyberspace
Patient consent to participate in the study
Getting a score of 5 or higher in the Beck Depression Inventory
Getting a score of 36 and below in Schneider Life expectancy questionnaire
Exclusion criteria:
Withdrawal from attending logotherapy sessions
Deterioration of physical condition
Occurrence of a critical accident while studying for the patient
Absence from more than one session
See a psychiatrist or psychologist while studying and undergoing psychotherapy or medication
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Using the available sampling method and taking into account the drop in samples, 50 people who meet the criteria for entering the study will be selected and randomly (by choosing one of the two cards that contain the content of number 1 or 2) will be placed in two control and intervention groups. In this way, 25 people will be assigned to each of the control and intervention groups. The control group will not receive group logotherapy. The groups will fit together.
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 Urmia University of Medical Sciences
Street address
Unit Fourteen, Fifth Floor, Nine Apartments, Opposite Aftab Apartments, Baqer Sonboli Alley, Kashani St., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715774173
Approval date
2022-06-29, 1401/04/08
Ethics committee reference number
IR.UMSU.REC.1401.138
Health conditions studied
1
Description of health condition studied
Gastrointestinal cancer
ICD-10 code
C15-C26
ICD-10 code description
Malignant neoplasms of digestive organs
Primary outcomes
1
Description
depression
Timepoint
Before the intervention, four days and thirty days after the intervention
Method of measurement
Beck Depression Inventory
2
Description
Life expectancy
Timepoint
Before the intervention, four days and thirty days after the intervention
Method of measurement
Schneider Life expectancy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will be randomly divided into two groups of 12 and 13 people. 10 group logotherapy sessions will be held for the intervention group. Meetings will be held daily except Thursday and Friday, and each meeting will be 60-90 minutes. Holding logotherapy sessions will be based on the Frankel school. The intervention group will also receive the hospital's routine interventions in addition to logotherapy.
Category
N/A
2
Description
Control group: Will receive routine hospital interventions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Laia Rezapour
Street address
Unit Fourteen, Fifth Floor, Nine Apartments, Opposite Aftab Apartments, Baqer Sonboli Alley, Kashani St., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715774173
Phone
+98 44 3347 0678
Email
rezapourlaia331@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Gholizadeh
Street address
Research and Technology Vice-Chancellor Building, University Headquarters, End of Emergency Coy, Resalat Blvd, Urmia.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Fax
+98 44 3224 0642
Email
research@umsu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Laia Rezapour
Position
Master's student in psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit Fourteen, Fifth Floor, Nine Apartments, Opposite Aftab Apartments, Baqer Sonboli Alley, Kashani St., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715774173
Phone
+98 44 3347 0678
Email
rezapourlaia331@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Moloud Radfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Unit 8, No. 10, 6th Quay, Dorostkar Street.
City
Urmia
Province
West Azarbaijan
Postal code
5719651543
Phone
+98 44 3368 5618
Fax
Email
mradfar1343@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Laia Rezapour
Position
Master's student in psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit Fourteen, Fifth Floor, Nine Apartments, Opposite Aftab Apartments, Baqer Sonboli Alley, Kashani St., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715774173
Phone
+98 44 3347 0678
Email
rezapourlaia331@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 documents will be published as articles. All demographic information such as age, education level, job position, etc. can be published. Also, the level of life expectancy and depression of people can be published.
When the data will become available and for how long
Access starts 3 months after results are published
To whom data/document is available
Accessible to all researchers in the field of psychiatry
Under which criteria data/document could be used
Comparison of demographic characteristics with life expectancy and depression or two groups with each other
From where data/document is obtainable
Moulad Radfar: Associate Professor of Urmia University of Medical Sciences Mradfar1343@gmail.com
Laia Rezapour: Master's degree in Urmia University of Medical Sciences rezapourlaia331@gmail.com
What processes are involved for a request to access data/document
Sending an email, and if there is no response after one day, calling on the phone and coordinating with the research members, and if they agree, provide information in about a week.