Protocol summary

Summary
Objectives: provide a simple executive strategy for managing of stress, creating a positive attitude and reducing the moral distress of novice nurses. Field of Study: randomized, double-blind, placebo-free, multi-center, one phase of clinical trial. A. Study population: Novice nurses in governmental hospitals in Khorramabad city. Inclusion criteria: Willingness to participate in the study; Nurses with Bachelor's Degree and Master's Degree; No history of mental illness; Not attending stress management training classes during the last year; Exclusion criteria: Reluctance to continue to participate in the study; The death of each participant during the study; Sample size: 70, with the possibility of sample loss. B) Intervention: The effect of stress management education using problem-solving approach on moral distress in novice nurses. C) The study period: from 11 September 2017 to 11 November 2017. D) The primary outcome: Creating a positive attitude and reducing the moral distress of novice nurses.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017042233569N1
Registration date: 2017-09-23, 1396/07/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-23, 1396/07/01
Registrant information
Name
Zeinab Biranvand
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86341735057
Email address
z.beiranvand@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Arak University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of stress management education using problem-solving approach on moral distress in novice nurses.
Public title
The effect of stress management education on nurses' moral distress.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study; Work experience less than 3 years; Age between 27-23 years; Nurses with Bachelor's Degree and Master's Degree; No history of mental illness Not attending to stress management training classes during the last year; Exclusion criteria: reluctance to continue to participate in the study; Death of each participant during the study; Transfer to another city for work;
Age
From 22 years old to 26 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples were selected and randomly assigned to intervention and control groups, using blocking method.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Commitee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alam al hoda St, Rail road St
City
Arak
Postal code
38481-7-6941
Approval date
2017-04-23, 1396/02/03
Ethics committee reference number
IR.ARAKMU.REC.1395.449

Health conditions studied

1

Description of health condition studied
Moral Distress
ICD-10 code
F60.2
ICD-10 code description
Dissocial personality disorder

Primary outcomes

1

Description
Moral Distress
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Querly moral confusion questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: There is no intervention for the control group
Category
Behavior

2

Description
Intervention group: problem solving skills workshop for novice nurses in 7 sessions
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Governmental hospitals in Khorramabad city
Full name of responsible person
Morovaat Taheri Kalani, Vice Chancellor for Research of Lorestan University of Medical Sciences
Street address
Vice Chancellor for Research of Lorestan University of Medical Sciences, Khorram abad
City
Khorram abad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Arak University of Medical Sciences
Full name of responsible person
Dr Ali Arash Anoshirvani, Vice Chancellor for Research of Arak University of Medical Sciences
Street address
Vice Chancellor for research, University complex of great prophit, sardasht region
City
Arak
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 of Arak 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
Arak University of Medical Science
Full name of responsible person
Zeynab Biranvand
Position
MSc Student of Nursing in Medical Surgical Field
Other areas of specialty/work
Street address
Great prophit university complex, sardasht region
City
Arak
Postal code
Phone
+98 86341735057
Fax
Email
nz.biranvand.22@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
PhD of Nursing Education
Other areas of specialty/work
Street address
Great prophit university complex, sardasht region
City
Arak
Postal code
38481-7-6941
Phone
+98 86341735057
Fax
Email
sajadimahbobeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zeynab Biranvand
Position
MSc Student of Nursing in Medical Surgical Field
Other areas of specialty/work
Street address
Great prophit university complex, sardasht region
City
Arak
Postal code
68166-95477
Phone
+98 86341735057
Fax
Email
nz.biranvand22@gmail.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
Loading...