Protocol summary

Summary
Objectives: This study aims at investigating the effects ofcognitive behavior therapy on quality of life and anxiety of Hematology and Oncology sections nurses and comparing the results to those of control group. Design: This study is a semi-experimental research based on pre-test and post-test with a control group. Research population consists of all hematology and oncology sections nurses. From the above-mentioned population, 30 subjects have been selected through available non-random sampling. Setting and conduct: Subjects are divided into two experimental and control groups in a random manner. Then, subjects in the experimental group are being trained for cognitive behavior therapy in 8 sessions. Subjects in control group will not receive any training. Major Inclusion and Exclusion criteria: Working at hematology and oncology sections, Interested in attending in the study, and not having severe mental illnesses are of criteria for entering into the study. Not interested in attending in study and accompanied sever mental diseases are of criteria for exiting from the study. Interventions: Subjects in both experimental and control groups will be initially tested using measuring tools for quality of life and anxiety. Then, subjects in the experimental group are being trained for “cognitive behavior therapy” and will be post-tested for the extent of change in quality of life and anxiety and compared to those in control group. Main outcome measures: quality of life and anxiety are elementary consequent variables.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016072615590N4
Registration date: 2016-09-04, 1395/06/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Mansoor Beyrami
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 313 4470
Email address
m.bayrami@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hematology and Oncology Research , Tabriz University of Medical Science
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of cognitive behavior therapy on quality of life and anxiety of hematology and oncology section,s nurses
Public title
Psychotherapy on quality of life and anxiety of nurses
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Working at hematology and oncology sections; Interested in attending in study; not having severe mental illness. Exclusion criteria: Not interested in attending in study; having severe mental illness sessions.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Committee for Ethics in biomedical research of Tabriz University of Medical Science
Street address
4tth office, First Floor, Ghazi Hospital, Tabriz University of Medical Science, Golghasht Street, Tabriz
City
Tabriz
Postal code
Approval date
2006-07-20, 1385/04/29
Ethics committee reference number
TBZMED.REC.1395.400

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders

Primary outcomes

1

Description
Quality of life
Timepoint
Before treatment and 1 week after
Method of measurement
Wrold Quality of Life Questionnaire

2

Description
Anxiety
Timepoint
Before treatment and 1 week after
Method of measurement
Beck Anxiety Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Experiment group will intervened with cognitive behavior therapy in 8 sessions. The component of intervention is: Knowing about anxiety, coping with stress, Relaxation, Diagnosing and coping negative thought
Category
Behavior

2

Description
Control group do not receipt any treatment program.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
Full name of responsible person
Pari Ghaem
Street address
2th office, First Floor, Ghazi Hospital, Tabriz University of Medical Science, Golghasht Street, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Jamal Eyvazi
Street address
3rth office, First Floor, Ghazi Hospital, Tabriz University of Medical Sciences, Golghasht Street, Tabriz
City
Tabriz
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, Tabriz 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
Tabriz University
Full name of responsible person
Shirin Zeinali
Position
PhD of psychology
Other areas of specialty/work
Street address
Child Psychology Office, Fourth Floor, Milad building, Corner of Mlli Bank, 17 Shahrivar Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3557 5849
Fax
Email
shirinzeinali@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University
Full name of responsible person
Jalil Babapour
Position
PhD
Other areas of specialty/work
Street address
First Floor, Faculty of Psychology, Tabriz University, Emam Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3339 2080
Fax
Email
shirinzeinali@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University
Full name of responsible person
Shirin Zeinali
Position
PhD
Other areas of specialty/work
Street address
Faculty of Psychology, Tabriz University, Emam Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3557 5849
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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