Protocol summary

Summary
1-The goal:Research on the effect of the emotional intelligence education on depression in cancerous patients that hospitalized in chemotherapy department. 2-Designing: This study is a randomized, not blind study, that has been done by Parallel Groups and sample group are 88 patients.The Statistical society of this study are patients with cancer that hospitalized in chemotherapy center 3-Method: Patients in both groups before the implementation of the program will participate in a pre test. For data collection we will use Beck Depression questionaire and Bar-on Emotional Intelligence questionnaire. Educational programs in the study include eight sessions, in 8 weeks that each session will run in maximum 1 hour. Finally after eight weeks of training for the second time we will give questionnaires to patients Inclusion and Exclusion criterias:4 For selection of cases after assessment of desirable condition and willingness to participate in training program and consent of them, they are allowed to leave the study in each stage of the project that they don’t want to cooperate and continue with us. Implementations:5 Session 1: Emotional self-awareness Session 2:Assertiveness Session 3: Self-actualization Session 4: Independence Session 5:Empathy Session 6: self confidence Session 7: Interpersonal relationships Session 8: Social responsibility 6-The main outcome variables: Emotional intelligence and Depression

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015070420401N5
Registration date: 2015-09-08, 1394/06/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-08, 1394/06/17
Registrant information
Name
Nazafarin Hosseini
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5144
Email address
hosseini.nazafarin@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Yasuj University of Medical Sciences
Expected recruitment start date
2015-04-09, 1394/01/20
Expected recruitment end date
2015-05-10, 1394/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the components of emotional intelligence depression in cancer patients undergoing chemotherapy control and intervention groups
Public title
The effect of emotional intelligence components on reducing depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criterias: The patients should be entered in to research consciously and with their desire.also patients that enter to study are hospitalized in chemotherapy unit and drugs or chemotherapy have reduced their symptoms and they are going to cure.End stage cancerous patients don’t enter to this study. Depressed mood with mild to sever degree(14-19:mild depression,20-28:moderate depression,29-63:sever depression)that is screened by Beck questionnaire and not use of anti depressant drugs or similar drugs are the criterias of entering to study. Exclusion criterias: The reluctance of patients to participate in the study؛ patients death or emigration during study period cause exclusion from the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Blocked randomized that patients will be divided in to two groups

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
St. martyr Motahari Yasouj University of Medical Sciences
City
Yasouj
Postal code
Approval date
2015-03-16, 1393/12/25
Ethics committee reference number
93.12.25.01

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F00-F99
ICD-10 code description
F30,F31,F32,F33,F34,F35,F36,F37,F38,F39

Primary outcomes

1

Description
Emotional Intelligence
Timepoint
Before and eight weeks after intervention
Method of measurement
Bar-On Emotional Intelligence Questionnaire

Secondary outcomes

1

Description
Depression
Timepoint
Before and eight weeks after intervention
Method of measurement
Beck Depression Inventory

Intervention groups

1

Description
The first group is case group that will have educational sessions. Session 1: Emotional self-awareness: Training the ability to evaluate and expressed excitement about the self and others. control and emotion regulation skills of self and others and excitement in problem –solving. Session 2:Empathy: Training the ability to aware of the feelings of others and also understand their feelings. Session 3:Assertiveness: Training the ability to express feelings , ideas , thoughts and also defend the rights of a person in a constructive way Session 4: self confidence: Having knowledge, understanding and acceptance and self-esteem training Session 5: Self-actualization: Training realize the potential of self Session 6: Independence: Education of self-control command in the thinking and practice personal and emotional dependency. Session 7: Interpersonal relationships: Knowledge and understanding of the feelings of others as well as create and maintain relationships of mutual satisfaction. Session 8: Social responsibility: Training to be the effective and productive members of their social group
Category
Behavior

2

Description
The second group is control goroup that no implementation will down on them and they are as witness.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Martyr Rajai Hospital of Yasouj
Full name of responsible person
Hamide ghasemi
Street address
Street martyr Galilee, near Imam Sajjad Hospital, School of Nursing and Midwifery class 1 medical science Yasuj
City
Yasouj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Yasuj University of Medical Sciences
Full name of responsible person
Dr.KHeyrollah nourian
Street address
Street martyr Galilee, near Imam Sajjad Hospital, School of Nursing and Midwifery class 1 medical science Yasuj
City
Yasouj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Yasuj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University of Yasuj Medical Sciences
Full name of responsible person
Hamide ghasemi
Position
Masters student Psychiatric Nursing
Other areas of specialty/work
Street address
Street martyr Galilee, near Imam Sajjad Hospital, School of Nursing and Midwifery class 1 medical science Yasuj
City
Yasouj
Postal code
Phone
+98 74 3323 5144
Fax
Email
h_a.ghasemi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Yasuj Medical Sciences
Full name of responsible person
Dr.KHeyrollah Nourian
Position
Phd
Other areas of specialty/work
Street address
Street martyr Galilee, near Imam Sajjad Hospital, School of Nursing and Midwifery class 1 medical science Yasuj
City
Yasouj
Postal code
Phone
+98 74 3323 5144
Fax
Email
khnooryan@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Yasuj Medical Sciences
Full name of responsible person
Hamide ghasemi
Position
Master student in Psychiatric Nursing
Other areas of specialty/work
Street address
Street martyr Galilee, near Imam Sajjad Hospital, School of Nursing and Midwifery class 1 medical science Yasuj
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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