Investigating the effect of communication skills education to intensive care unit staff on anxiety, depression and satisfaction of patients’ family and the staff’s self-confidence
Determining the effect of communication skills education to the staff on anxiety, depression and satisfaction of patients’ family and the staff’s self-confidence
Design
Non randomized clinical trial, non equivalent control group
Settings and conduct
The study will perform in ICU of Seyed Alshohada Hospital in Isfahan. It will start with collecting data from family members using convenience sampling. Anxiety and depression of the patient's family will assess by a questionnaire. In addition, family satisfaction with ICU staff communication will assess at the end of the fifth day of patient's ICU stay. Then, the educational intervention about communication skills will be held for all ICU staff. After finishing the educational course for the staff, anxiety, depression and satisfaction of patients' families will measure again. Also in this study, the staff self-confidence in terms of communication with patients' family will study before and after educational intervention using a questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: For staff: at least on year experience in ICU. For family member and patient: being first degree relative of patient, no history of suffering anxiety and depression, no history of ICU hospitalization for the patient, ICU stay of the patient at least for five days.
exclusion criteria: Unwillingness of family member to participate in the research.
Intervention groups
All ICU staff including nurses, doctors and other staff who have to communicate with the patients' families will participate in an educational course related to communication skills.
Main outcome variables
Anxiety, depression, satisfaction of patients’ family and the staff’s self-confidence in communication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181003041224N1
Registration date:2019-04-11, 1398/01/22
Registration timing:prospective
Last update:2019-04-11, 1398/01/22
Update count:0
Registration date
2019-04-11, 1398/01/22
Registrant information
Name
Farzaneh Salman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4428
Email address
f-salmand@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of communication skills education to intensive care unit staff on anxiety, depression and satisfaction of patients’ family and the staff’s self-confidence
Public title
Investigating the effect of communication skills education to the ICU staff on anxiety and satisfaction of patients’ family
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The staff must work in intensive care unit at least on year.
The patient's family member should be the first degree relative of patient.
The patient's family member has no history of known psychiatric disorders (depression and anxiety).
The patient has no history of admission to the ICU.
ICU stay of the patient should be at least five days.
Exclusion criteria:
Unwillingness of patient's family member to participate in the research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the intervention is going to do on the staff. However, dependent variable is measuring on the patients' families. First, the data of patients' families will collect. Then, the educational intervention will perform on the staff. After finishing the educational intervention, the data of patients' families will collect. So, in this study, there is not any random allocation and the patient' families will include in the study based on inclusion criteria (convenience sampling) in two different periods of time (before and after educational intervention on the staff).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional research ethics committee of Tehran University of Medical Sciences
Street address
Nursing and Midwifery faculty, Mirkani St., Towhid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-10-16, 1397/07/24
Ethics committee reference number
IR.TUMS.FNM.REC.1397.134
Health conditions studied
1
Description of health condition studied
Post-traumatic stress disorder (PTSD)
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
Score of anxiety and depression in Hospital Anxiety and Depression Scale
Timepoint
In the fifth day of the patient stay in ICU
Method of measurement
Hospital anxiety and depression scale
Secondary outcomes
1
Description
Satisfaction of the patient's family with ICU staff communication
Timepoint
The fifth day of the patient's hospitalization in ICU
Method of measurement
Family satisfaction with intensive care unit questionnaire (FS-ICU24)
2
Description
Self confidence of ICU staff
Timepoint
Before and after educational course
Method of measurement
Staff confidence in communication with patients and their families questionnaire
Intervention groups
1
Description
The intervention is a communication skills educational course for ICU staff including nurses, doctors and other staff who have to communicate with the patients' families. Duration of educational course is one month and including two workshops, each in one day, plus sending SMS about communication skills to the staff. In addition, related educational posters and pamphlets will be deliver to them.
Category
Behavior
2
Description
Control group: Families of ICU patients are the control group who their anxiety, depression and satisfaction with communication of the staff will be assessed before educational intervention using a questionnaire.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed Alshohada Hospital
Full name of responsible person
Farzaneh Salman Dehkordi
Street address
Seyed Alshohada Hospital, Motahhari Ave., Isfahan Town
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3236 8005
Email
salman.farzane@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohamad Ali Sahraeiyan
Street address
The 6th floor, Central Building of University, Ghods St., Keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3698
Fax
Email
msahrai@tums.ac.ir
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
Farzaneh Salman Dehkordi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Mirkhani St., Towhid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 2700
Email
salman.farzane@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoomeh Imanipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Faculty of Nursing and Midwifery, Mirkhani St., Towhid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4430
Email
m_imanipour@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzaneh Salman Dehkordi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Mirkhani St., Towhid Sq.uare., Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 2700
Email
salman.farzane@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Data will publish in group form and without any identification code.
When the data will become available and for how long
After approving the journal decision about acceptance and publication of the data as an article
To whom data/document is available
Editors of scientific journals
Under which criteria data/document could be used
No new analysis is permitted and the data can just use for information and checking quality and trustworthiness.
What processes are involved for a request to access data/document
After receiving a request from editors, the research team will have a meeting and make a decision about which part of data can publish. Then, after declining any identification code, the data will send through email or fax.