Protocol summary

Study aim
The main purpose of this study is to determine the effect of communication skills training on nurses' moral distress in Motahari teaching hospital of Jahrom University of Medical Sciences in 2019
Design
Two arm parallel group randomised trial and outcome assessment
Settings and conduct
This is an experimental study in Motahari teaching hospital of Jahrom University of Medical Sciences, 50 nurses will be divided into control and intervention groups randomly by computer, then moral distress questionnaire will be completed by both groups. the nurses' moral distress will be measured in both intervention and control groups after one month from the end of the intervention
Participants/Inclusion and exclusion criteria
1. Nurses' consent to participate in the study. 2. At least one year of work experience. 3. No illness or use of psychotropic drugs. 4. Non-participation in other interventional studies with ethical or communication issues. 5. Having moderate to high moral distress in the initial assessment of hospital staff's moral distress
Intervention groups
The moral distress questionnaire will be completed by both control and intervention groups before starting the study. The intervention group will be trained in 4 two-hour sessions during one month. Then, the nurses' moral distress will be measured in both intervention and control groups after one month from the end of the intervention . Following the completion of the research, communication skills training sessions will also be conducted for the control group regarding to medical ethics.
Main outcome variables
1. Achieving different individual outcomes such as: improving physical and mental health, increasing job productivity etc 2. Reduce Nursing Ethical Consequences for Nurses in a variety of areas including: managerial, personal and clinical 3. Pay more attention to communication skills training in medical universities

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191125045491N1
Registration date: 2020-01-06, 1398/10/16
Registration timing: prospective

Last update: 2020-01-06, 1398/10/16
Update count: 0
Registration date
2020-01-06, 1398/10/16
Registrant information
Name
Mohammad Sobhanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5444 0769
Email address
m.sobhanian@jums.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2641-03-20, 2019/12/29
Expected recruitment end date
2641-04-20, 2020/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying The effect of communication skills training on nurses' moral distress
Public title
Studying The effect of communication skills training on moral distress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses' consent to participate in the study At least one year of working experience No illness or use of psychotropic drugs Failure to participate in other interventional studies with ethical or communication issues at the same time Having moderate to high moral distress in the initial assessment of hospital staff's moral distress
Exclusion criteria:
Mental illness that can disrupt educational and communication processes during the study Absence of more than two sessions in communication skills training workshops Attend communication skills training workshops in the past 6 months Nurses working in CCU wards, neonatal intensive care unit, dialysis, supervising office and eye surgery at the time of the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
50 nurses will be selected randomly by computer software, and randomly assigned code 1 in the control group and code 2 in the intervention group by computer .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Jahrom University of Medical Sciences
Street address
jahrom, motahari ave, Jahrom University of Medical Sciences
City
jahrom
Province
Fars
Postal code
74148416199
Approval date
2019-12-31, 1398/10/10
Ethics committee reference number
IR.JUMS.REC.1398.057

Health conditions studied

1

Description of health condition studied
medical ethics
ICD-10 code
moral dist
ICD-10 code description
training , Communication skills, moral distress, nursing

Primary outcomes

1

Description
Average of moral distress score
Timepoint
before intervention and 1 month after intervention
Method of measurement
Hamric's moral Distress Questionnaire

Secondary outcomes

1

Description
not contained
Timepoint
not contained
Method of measurement
not contained

Intervention groups

1

Description
Intervention group: first, the moral distress questionnaire will be completed individually before the intervention, and then for this group, communication skills training will be conducted in 4 two-hour sessions in one month based on the educational content chapter extracted from other articles and The scientific literatures as follows: during the first session we will focus on basic concepts of communication, factors affecting communication, and effective communication skills of nurses with other members of the medical team (including physician, nurse, service personnel, etc.), Patients and their families. in the second session: transferring medical information and necessary required actions to the physician and other medical team members, effective feedback, communicating with patients with special needs and transferring medical information, disease prognosis and different treatment methods to the patients and their families will be discussed, in the third session we will focus on communication barriers, anger control skills, Rejection skills and how to deal with the aggressive patient and family. and finally in the last session we will focus on ethics in communicating and the exchange of different point of views and expert scientific opinions. then Nurses' moral distress will be measured one month after the intervention.
Category
Other

2

Description
Control group: first, the moral distress questionnaire will be completed individually, then again two months later the moral distress questionnaire will be completed by this group. After completing the research and following the ethics of research in case of positive effect of communication skills on nurses' moral distress in intervention group, communication skills training sessions will be conducted for control group too.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari hospital
Full name of responsible person
mohammad sobhanian
Street address
jahrom, motahari ave, motahari hospital
City
jahrom
Province
Fars
Postal code
7415713597
Phone
+98 71 5433 6006
Fax
+98 71 5433 6006
Email
motaharipr@gmail.com
Web page address
http://motahari.jums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
mohammad sobhanian
Street address
jahrom, motahari ave, motahari hospital
City
jahrom
Province
Fars
Postal code
74148416199
Phone
+98 71 5433 6006
Fax
+98 71 5433 6006
Email
motaharipr@gmail.com
Web page address
http://motahari.jums.ac.ir/
Grant name
Jahrom University of Medical Sciences
Grant code / Reference number
not applicable
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
mohammad sobhanian
Position
master of nursing student
Latest degree
Bachelor
Other areas of specialty/work
Medical Ethics
Street address
jahrom, enghelab ave, resalat street
City
jahrom
Province
Fars
Postal code
7419744379
Phone
+98 71 5444 0769
Fax
+98 71 5433 6006
Email
sobhanianmohamad@gmail.com
Web page address
http://motahari.jums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
mohammad sobhanian
Position
master of nursing student
Latest degree
Bachelor
Other areas of specialty/work
Medical Ethics
Street address
jahrom, enghelab ave, resalat street
City
jahrom
Province
Fars
Postal code
7419744379
Phone
+98 71 5444 0769
Fax
+98 71 5433 6006
Email
sobhanianmohamad@gmail.com
Web page address
http://motahari.jums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
sobhanian mohammad
Position
master of nursing student
Latest degree
Bachelor
Other areas of specialty/work
Medical Ethics
Street address
jahrom, enghelab ave, resalat street
City
jahrom
Province
Fars
Postal code
7419744379
Phone
+98 71 5444 0769
Fax
+98 71 5433 6006
Email
sobhanianmohamad@gmail.com
Web page address
http://motahari.jums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
for ethical reasons
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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