Protocol summary

Study aim
To assess the effect of diagnoses, interventions and nursing outcomes on the nursing care related to patient safety in psychiatric wards
Design
Clinical trial with Control and Experimental Groups, Factorial, Double-blind, randomized allocation
Settings and conduct
In a clinical trial, 80 nurses working in Roozbeh Hospital were choosed and randomly assigned in two groups, control and experimental. The intervention of the study is training of signs, symptoms and etiology of important phenomena in psychiatric wards to select the correct nursing diagnoses and interventions in order to achieve the desired nursing outcomes. Nursing documented reports were reviewed and analyzed
Participants/Inclusion and exclusion criteria
Participants: Nurses working in Roozbeh hospital Psychiatric wards Inclusion Criteria - Written and informed consent to participate in the research - Minimum of Bachelor's degree in Nursing - Work in psychiatric wards as a Clinical Nurse Exclusion criteria -Refuse to continuing of corporation in the research -Transfer from psychiatric hospital to another center during the study period
Intervention groups
The study groups consist of two experimental and control groups. The intervention conducts in the experimental group, while control group receives no intervention
Main outcome variables
Improvement in the Nursing care related to Patient safety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170917036237N2
Registration date: 2018-10-01, 1397/07/09
Registration timing: retrospective

Last update: 2018-10-01, 1397/07/09
Update count: 0
Registration date
2018-10-01, 1397/07/09
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3374 2587
Email address
b-saatchi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of "Nursing Process Based on the Nursing Diagnoses, Nursing Interventions Classifications and Nursing Outcomes Classifications" Training, on the Patient Safety in Psychiatric Wards
Public title
Effect of Nursing Diagnoses Training on the Patient Safety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Written and informed consent to participate in the research Having at least a Bachelor's degree in Nursing Employment in Psychiatric ward as a Clinical Nurse
Exclusion criteria:
Reject to continue participation in the research Transfer or resign from psychiatric hospital to another center during the study period
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were selected by convenient sampling method, and assigned randomly by blocked randomization to experimental and control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in this study are Nurses working in psychiatric wards. The researcher of this study has the role of educator in collecting information and analysis of the results, and is unaware of the implications of this study.
Placebo
Not used
Assignment
Parallel
Other design features
The study samples are nurses working in psychiatric wards, so there is no patient-choosing in this study

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Joint Committee of Ethics of Nursing and Midwifery Faculty with Faculty of Rehabilitation Tehran Uni
Street address
School of Nursing and Midwifery, Tohid Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2697

Health conditions studied

1

Description of health condition studied
Nursing care related to Patient Safety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Nursing care related to patient safety
Timepoint
Before the intervention, 8 weeks after the intervention
Method of measurement
Questionnaire designed by researcher, to measure the frequency of using nursing Diagnoses, Interventions and Outcomes

Secondary outcomes

empty

Intervention groups

1

Description
Intervention on the intervention group, conducted during the four sessions of two-hour training courses, two months, and they will be taught by the researcher in the Roozbeh Hospital. The training includes training NANDA-I nursing diagnosis, Nursing Intervention Classification (NIC), and NANDA-I classification of nursing outcomes (NOC). The Safety/Protection domain has nursing diagnoses in six classes of infection, physical harms, violence, physical hazards, defensive processes and body thermoregulation, along with each of these diagnoses, interventions and related nursing outcomes will be taught too. The research intervention focused on teaching signs, symptoms and etiology of the common phenomena in the psychiatric wards to choose nursing diagnoses related to needs and problems of the patient, and choosing nursing interventions to achieve short, medium and long term outcomes.
Category
Other

2

Description
Control group: no intervention, conducted on this group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Babak Saatchi
Street address
No. 606, District 11, South Kargar St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Fax
+98 21 5541 2756
Email
hosp_roozbeh@tums.ac.ir
Web page address
http://roozbehhospital.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadali Sahrayian
Street address
Central Organization of the University, 6th floor of Research and Technology Department, Ghods St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Fax
+98 21 8163 3047
Email
tums@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/index.jsp?fkeyid=&siteid=22&pageid=203
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Babak Saatchi
Position
Student of Psychiatric Nursing MSc
Latest degree
Bachelor
Other areas of specialty/work
روان پرستاری
Street address
Unit 3, No 8, Khazeie Alley, Fereshteh Ave, Azarbaijan St, Navvab, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1345883414
Phone
+98 21 6635 1248
Fax
Email
b-saatchi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Babak Saatchi
Position
Master Student of Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Psychiatric Nursing
Street address
Tehran, Navvab, Dampezeshki St, Salman farsi Ave, Khazei Alley, No 3
City
Tehran
Province
Tehran
Postal code
1345883414
Phone
+98 21 6635 1248
Fax
Email
b-saatchi@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Babak Saatchi
Position
Student of Psychiatric Nursing MSc
Latest degree
Bachelor
Other areas of specialty/work
Psychiatric Nursing
Street address
Tehran, Navvab, Dampezeshki St, Salman farsi Ave, Khazei Alley, No 3
City
Tehran
Province
Tehran
Postal code
1345883414
Phone
+98 21 6635 1248
Fax
Email
b-saatchi@razi.tums.ac.ir
Web page address

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
Undecided - It is not yet known if there will be 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
Not applicable
Title and more details about the data/document
Demographic and Occupational data of the studied samples
When the data will become available and for how long
At the time thesis defended
To whom data/document is available
The project executives, and the rest of the people are subject to the permission of the main executor of the project
Under which criteria data/document could be used
Obtain permission by expressing the purpose of using documentation and data from the project executives
From where data/document is obtainable
Contact with this Email address: b-saatchi@razi.tums.ac.ir
What processes are involved for a request to access data/document
Contact project executives and obtaining access permissions
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