Protocol summary

Summary
Nurses face a great amount of stress that can threaten their health and reduce their motivation. Nurses’ most important stressful factors include working overload , being in close touch with patients’ death ,shift working, lack of psychological support, conflicts with the physicians, confusion in autonomy and progressive increase of bureaucratic process. This phenomenon can have destructive physiologic and psychological effects on nurses and negatively influence their health. On the other hand, stress , anxiety and depression reduce quality of patients’ care through increase of work events , delay and absenteeism and reduction of work efficiency and organizational commitment . Nurses’ present working conditions lead to an increase in emotional pressures and depression. There are various studies on the effect of happiness education on increase of happiness and reduction of stress, anxiety and depression in different social classes ,but the researcher found no studies, conducted among nurses taking care of cancer patients. Conducting such a study seems to be necessary ,with regard to nurses’ stressful working conditions, to take steps toward achieving different and non-medicational treatments to treat their stress , anxiety and depression and increase their happiness , and consequently, promote nurses’ and patients’ health. This study is a clinical trial to determine effect of happiness educational program on the level of nurses’ happiness , stress , anxiety , and depression in nurses (employed or working on a contract ) working in Seyed-Al-Shohada (peace on him) hospital for more than one year field two-group three- stage with sample size 52 subjects in study and control groups

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014102814463N3
Registration date: 2014-11-09, 1393/08/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-11-09, 1393/08/18
Registrant information
Name
Zahra Ghazavi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7580
Email address
zahra_ghazavi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of happiness educational program on the level of nurses’ happiness , stress , anxiety , and depression
Public title
Effect of happiness educational program on the level of nurses’ happiness , stress , anxiety , and depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The subjects who are interested in attending the research; Nurses (employed or working on a contract ) working in Seyed-Al-Shohada (peace on him) hospital for more than one year; Having no history of a diagnosed psychological or mental disease that needs psychotropic medications; Absense of acute and chronic diagnosed diseases during study; No simultaneous participation in any similar research projects or educational workshops Exclusion criteria: Subjects’ personal interest to leave the study; Subjects’ absenteeism in classes for more than two sessions; Facing an acute crisis during study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences,Hezar Jerib Ave.
City
Esfahan
Postal code
Approval date
2014-06-01, 1393/03/11
Ethics committee reference number
393176

Health conditions studied

1

Description of health condition studied
Mental and behavioural disorders
ICD-10 code
F32
ICD-10 code description
Depressive episode

2

Description of health condition studied
Mental and behavioural disorders
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

Primary outcomes

1

Description
Happiness
Timepoint
Before the intervention, Immediately after the intervention, One month after the intervention
Method of measurement
Oxford questionnaire

2

Description
Depression
Timepoint
Before the intervention, Immediately after the intervention, One month after the intervention
Method of measurement
DASS42 questionnaire

3

Description
Anxiety
Timepoint
Before the intervention, Immediately after the intervention, One month after the intervention
Method of measurement
DASS42 questionnaire

4

Description
Stress
Timepoint
Before the intervention, Immediately after the intervention, One month after the intervention
Method of measurement
DASS42 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
After selection of an adequate number of subjects, educational program will be administrated in form of six 60-minute sessions once a week in study group. Lecture , group discussion , Q&A and brain storming will be adopted in the sessions. At the end of the sixth session , DASS42 and Oxford questionnaires will be completed again in study group. Finally, to investigate the longevity of treatment , DASS42 and Oxford questionnaires will be completed for the third time in study group in Seyed-Al-Shohada educational center.
Category
Behavior

2

Description
The researcher will also distribute happiness related educational booklets in control group. It should be noted that a replacing interventional session of communicational skills will be considered in control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyed-Al-Shohada Educational center
Full name of responsible person
Dr Emami Majid
Street address
Polshiri Ave.
City
Esfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical.Science
Full name of responsible person
Taleghani Fariba
Street address
Hezar Jerib Ave., Isfahan University of Medical.Science, Nursing& Midvifery Faculty
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical.Science
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
Isfahan University of Medical Sciences
Full name of responsible person
Ghazavi Zahra/ Mardani Zahra
Position
Academic Member/ Master of Science
Other areas of specialty/work
Street address
Psychiatric Nursing Dep.Nursing Faculty, Isfahan University of Medical Sciences Hezar Jerib Ave.
City
Esfahan
Postal code
8174673461
Phone
+98 31 3792 2960
Fax
+98 31 3669 9398
Email
zahra_ghazavi@nm.mui.ac.ir zahra_mardany@yahoo.com
Web page address
www.nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ghazavi Zahra
Position
Academic Member/ Master of Sciences
Other areas of specialty/work
Street address
Psychiatric Nursing Dep, Nursing and Midvifery Faculty, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Esfahan
Postal code
8174673461
Phone
+98 31 3792 2960
Fax
+98 31 3669 9398
Email
zahra_ghazavi@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ghazavi Zahra/Mardani Zahra
Position
Academic Member/ Master of Science
Other areas of specialty/work
Street address
Psychiatric Nursing Dep, Nursing and Midvifery Faculty, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Esfahan
Postal code
8174673461
Phone
+98 31 3792 2960
Fax
+98 316699398
Email
zahra_ghazavi@nm.mui.ac.ir zahra_mardany@yahoo.com
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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