Protocol summary

Study aim
The purpose of this study was to investigate, evaluate, and correlate the level of Emotional Intelligence and leadership models of primary health care nurses using a questionnaire and after an educational intervention or not.
Design
A longitudinal, stratified and randomized, controlled clinical trial with a parallel group design of 101 primary health care nurses, enrolled between May 2022 and December 2022.
Settings and conduct
The intervention group included a sample of 50 people, while the sample for the control group was 51 people. The sample included primary care nurses from various geographical areas of Greece and from various types of Primary Health Care facilities, such as Health centers, Local Health Groups, Mental Health Centers, etc.
Participants/Inclusion and exclusion criteria
Inclusion criteria. The nurses should: speak the Greek language, have a tertiary (four-year) education in nursing, consent to their participation in this research, work in Primary Health Care institutions. Exclusion criteria: Other paramedical staff or supervisors, who practice nursing work, without holding a nursing diploma or degree (e.g., midwives) and nursing assistants, who have two years of nursing training.
Intervention groups
Regarding the research sample, two groups were created, the control group and the intervention group. The intervention group nurses initially completed the questionnaire (pre-test), then immediately after the educational intervention, within one week, they completed the questionnaire again (post-test). In contrast to the intervention group, the nurses who made up the control group completed the questionnaire in the first phase, there was no educational intervention, and they immediately afterwards in a second phase within one month completed the questionnaire again.
Main outcome variables
Emotional intelligence and leadership

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240126060816N1
Registration date: 2024-01-30, 1402/11/10
Registration timing: retrospective

Last update: 2024-01-30, 1402/11/10
Update count: 0
Registration date
2024-01-30, 1402/11/10
Registrant information
Name
Maria Fragkaki
Name of organization / entity
University of West Attica
Country
Greece
Phone
+30 21 0538 5616
Email address
mmfragkaki@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-01, 1401/02/11
Expected recruitment end date
2022-12-31, 1401/10/10
Actual recruitment start date
2022-05-01, 1401/02/11
Actual recruitment end date
2022-12-31, 1401/10/10
Trial completion date
2022-12-31, 1401/10/10
Scientific title
Emotional intelligence and nursing leadership: a randomized controlled trial in nurses in primary health care
Public title
Emotional intelligence and nursing leadership: a study in nurses in primary health care
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The nurses should: speak the Greek language. Have a tertiary (four-year) education in nursing. Consent to their participation in this research. Work in Primary Health Care institutions.
Exclusion criteria:
Other paramedical staff or supervisors, who practice nursing work, without holding a nursing diploma or degree (e.g., midwives). Nursing assistants, who have two years of nursing training.
Age
From 22 years old to 67 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 101
Randomization (investigator's opinion)
Randomized
Randomization description
In order to create a more representative sample, proportional stratified and simple random sampling was used to select the studied population. This included primary care nurses from various geographical areas of Greece. With regard to our research study, upon request, the conduct of the research was approved by the scientific councils of all the health districts of Greece. They sent us a list of all primary health care units (name, address, telephone, email). We selected the health centers according to the geographical area by lottery and then we contacted with each health center that had been selected. Nurses who worked in the 1st health center were assigned to the intervention group and nurses who worked in the 2nd health center were assigned to the control group. Then we continued in this way until the sample size was at least 50 nurses in both groups.
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
Research Ethics Committee of the University of West Attica
Street address
No. 28 Ag. Spiridonos
City
Athens
Postal code
12243
Approval date
2022-02-15, 1400/11/26
Ethics committee reference number
12758

Health conditions studied

1

Description of health condition studied
Emotional intelligence and leadership models
ICD-10 code
R45.89
ICD-10 code description
Other symptoms and signs involving emotional state

Primary outcomes

1

Description
Emotional intelligence
Timepoint
For the intervention group before and one week after the intervention. For the control group before and after one month without intervention.
Method of measurement
Questionnaire: Wong & Law Emotional Intelligence Scale.

2

Description
Leadership models
Timepoint
For the intervention group before and one week after the intervention. For the control group before and after one month without intervention.
Method of measurement
Questionnaire: Multifactor Leadership Questionnaire (5x short).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group nurses initially completed the questionnaire (pre-test), then immediately after the educational intervention, within one week, they completed the questionnaire again (post-test).The educational intervention theme, which was implemented utilizing recommendations, was the significance, advantages, and problems associated with Emotional intelligence and leadership. Case studies were given at the conclusion of the lecture, providing an opportunity for debate and introspection. The intervention group included a sample of 50 primary health care nurses.
Category
Other

2

Description
Control group: The nurses who made up the control group completed the questionnaire (pre-test) in the first phase, there was no educational intervention, and they immediately afterwards in a second phase within one month completed the questionnaire (post-test) again. The sample for the control group was 51 primary health care nurses.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
1st Ηealth region of Greece - scientific council of health district
Full name of responsible person
Panagiotis Stathis
Street address
No 2 Makedonon
City
Athens
Postal code
11521
Phone
+30 21 0644 1166
Email
ekpedeysi@dype1.gov.gr

2

Recruitment center
Name of recruitment center
2st Ηealth region of Greece - scientific council of health district
Full name of responsible person
Periklis Alevizos
Street address
No 196-198 Thivon
City
Athens
Postal code
18233
Phone
+30 21 3200 4200
Email
nikita@2dype.gov.gr

3

Recruitment center
Name of recruitment center
3st Ηealth region of Greece - scientific council of health district
Full name of responsible person
Panagiotis Mpogiatzidis
Street address
No 16 Aristotelous
City
Thessaloniki
Postal code
54623
Phone
+30 231 330 5224
Email
tmaurea@3ype.gov.gr

4

Recruitment center
Name of recruitment center
4st Ηealth region of Greece - scientific council of health district
Full name of responsible person
Eirini Xatzopoulou
Street address
No 16 Aristotelous
City
Thessaloniki
Postal code
54623
Phone
+30 231 332 7897
Email
drousaki@4ype.gr

5

Recruitment center
Name of recruitment center
5st Ηealth region of Greece - scientific council of health district
Full name of responsible person
Kiriaki Droggoudi
Street address
Mezourlo
City
Larissa
Postal code
41110
Phone
+30 241 350 0837
Email
anap@dypethessaly.gr

6

Recruitment center
Name of recruitment center
6st Ηealth region of Greece - scientific council of health district
Full name of responsible person
Giannis Karbelis
Street address
No 1 Ypatis and N.E.O. Patron-Athinon
City
Patra
Postal code
26441
Phone
+30 261 360 0578
Email
6ype@dypede.gr

7

Recruitment center
Name of recruitment center
7st Ηealth region of Greece - scientific council of health district
Full name of responsible person
Eleni Mpormpoudaki
Street address
No 3st km Ethniki Odos Irakleiou-Moiron
City
Heraklion Crete
Postal code
71500
Phone
+30 281 033 1570
Email
dprogram@hc-crete.gr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of West Attica
Full name of responsible person
Prof. Fasoi Georgia (supervisor)
Street address
No 28 Ag. Spiridonos
City
Athens
Postal code
12243
Phone
+30 21 0538 5616
Email
nurs@uniwa.gr
Web page address
https://nurs.uniwa.gr/
Grant name
There is not exist grant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
There is not exist grant
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
University of West Attica
Full name of responsible person
Georgia Fasoi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health/Community Medicine
Street address
No. 28, Ag. Spiridonos
City
Athens
Province
Egaleo
Postal code
12243
Phone
+30 21 0538 5699
Email
gfasoi@uniwa.gr

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of West Attica
Full name of responsible person
Georgia Fasoi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health/Community Medicine
Street address
No. 28, Ag. Spiridonos
City
Athens
Province
Egaleo
Postal code
12243
Phone
+30 21 0538 5699
Email
gfasoi@uniwa.gr

Person responsible for updating data

Contact
Name of organization / entity
University of West Attica
Full name of responsible person
Maria Fragkaki
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Public Health/Community Medicine
Street address
No. 28, Ag. Spiridonos
City
Athens
Province
Egaleo
Postal code
12243
Phone
+30 281 022 4702
Email
mmfragkaki@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
No - There is not a plan to make this available
Title and more details about the data/document
In the form of thesis, article
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in academic
Under which criteria data/document could be used
Research on improving emotional intelligence and leadership skills
From where data/document is obtainable
The applicant could get the documents from the University of West Attica (Address: Ag. Spiridonos, No.28, Athens, Greece) or alternatively from the researchers Maria Fragkaki (Email: mmfragkaki@gmail.com) and Prof. Georgia Fasoi (Email: gfasoi@uniwa.gr).
What processes are involved for a request to access data/document
Τhe process of getting the documents will not be time-consuming. We believe that within two weeks you will have the necessary documents. We could communicate via email: mmfragkaki@gmail.com
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