Assessment the effect of education on quality of caring interactions in nurses and patients in the cardiac care units of Kerman University Hospitals
Design
Clinical trial with control and intervention group, one-way blinded, randomized, with a total of36nurses and152patients
Settings and conduct
Patients were randomly selected among patients with at least three days of hospitalization.They are first selected as the evaluated group before the intervention and again after the intervention.Attempts are made to select patients before and after the intervention in such a way that they are similar in variables affecting the outcome of the study. Nurses are placed in the control and intervention groups by simple random method from two independent heart wards. Also, this study is a blind one-way study and the data analyzer is blinded.
Participants/Inclusion and exclusion criteria
Patients should be hospitalized in cardiac wards for at least3days,patients should be at least18 years old, the general condition of the patient should be good,and she should have at least a literacy level.Nurses should have at least 6 months of clinical experience, WhatsApp smartphones, enough time to participate and collaborate in the study.
Intervention groups
Researcher in the group that created on the social network, invites the members of the intervention group to participate in sessions held through the WhatsApp. The training will be provided virtually one hour a day, every other day at a specific time of the day and for one month to the nurses of the intervention group.Educational videos downloaded from reputable sites with Persian subtitles will be placed in the group, also educational texts in Persian provided to the participants.
Main outcome variables
quality of caring interactions in nurses and patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220327054356N1
Registration date:2022-04-29, 1401/02/09
Registration timing:prospective
Last update:2022-04-29, 1401/02/09
Update count:0
Registration date
2022-04-29, 1401/02/09
Registrant information
Name
Anis Bahreini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 391 9939
Email address
anisbahreini1375@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the Effect of Education on quality of caring interactions in nurses and patients in the cardiac care units
Public title
Assessment the Effect of Education on quality of caring interactions in nurses and patients in the cardiac care units
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be hospitalized in cardiac wards for at least 3 days.
Patients should be at least 18 years old.
The general condition of the patient should be good.
Patients should have at least middle School degree.
Nurses must have at least 6 months of clinical experience.
Nurses must have a smartphone and WhatsApp.
Nurses must have enough time to participate in the study.
Exclusion criteria:
Patients with dementia and psychological problems according to self-declaration
Previous hospitalization history in the heart ward
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
188
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are readily available from among patients admitted to the cardiac wards of the hospital after three days of hospitalization, first selected as a pre-intervention group and again after the completion of the educational intervention on nurses, as a post-intervention group. It should be noted that 38 patients are from one cardiac ward and 38 patients are from the other ward. Nurses working in these two wards, which are a total of 36 people will be included in the study by census method and nurses of one ward will be assigned to the control group and the nurses of the other ward will be assigned to the intervention group by simple random sampling with a sealed envelope. Are given in such a way that in each envelope the name of one of the two desired cardiac sections is written and one section is randomly selected as the intervention group and the other section as the control group. In each envelope, the name of one of the two cardiac wards is written and one section is randomly selected as the intervention group and the other ward as the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer is blind and she does not know which data is for control group and intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Science
Street address
No. 1, East Amirkabir, Kheirkhah dead end alley, Rafsanjan, Kerman
City
Kerman
Province
Kerman
Postal code
7717693545
Approval date
2022-03-07, 1400/12/16
Ethics committee reference number
IR.KMU.REC.1400.668
Health conditions studied
1
Description of health condition studied
quality of caring interactions in nurses and patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Caring nurse-patient interaction
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Caring Nurse-Patient Interactions Scale: 23-item Version
2
Description
Caring interaction education
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Caring Nurse-Patient Interactions Scale: 23-item Version
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After describing the purpose of the study and obtaining informed consent, in the first session, the researcher presented a questionnaire including demographic characteristics of patients and caring nurse-patient interaction scale (patient-version) to patients with at least 3 days hospitalization at cardiac care units and a questionnaire including demographic characteristics of nurses and the caring nurse-patient interaction scale( nurse-version) to cardiac care unit nurses. Then the intervention by a researcher who has a bachelor of science in nursing and at least two years of experience working in cardiac care units after improving her knowledge about the effect of education on nurse-patient care interactions in a self-taught way, is provided. the training method will be as follows: To prevent the effect of nurses' behavior on each other and distort the study, nurses for intervention and control group will be chose from two different cardiac care units. The researcher then, through a group created on the social network, invites the members of the intervention group to participate in sessions held through the WhatsApp application. The training will be provided virtually one hour a day, every other day at a specific time of the day and for one month to the nurses of the intervention group. After the approval of the research team, educational videos downloaded from reputable sites with Persian subtitles will be placed in the group, also educational texts in Persian provided to the participants, and it should be mentioned to ensure Reading materials by nurses will send them a reminder message at a specific time. The researcher will also answer possible questions of the participants during the intervention through social networks and WhatsApp application. Questionnaires will be completed by nurses 1 month after the intervention. It is important to note that the intervention is performed only on nurses, and in order to assess the consequences of the intervention, the nurse-patient caring interaction questionnaire ( patient-version ), will be completed by patients who have been hospitalized for at least three days and in variables Age, sex, and many other variables are matched with patients before the intervention, Before and one month after the intervention. These questionnaires will be distributed and collected by a bachelor of science in nursing who is working in that cardiac care unit. The educational content that will be presented to nurses in this study will include the content presented in nursing reference books in the field of education and caring interaction between nurses and patients. Of course, references and articles available on international sites and reputable databases will also be used. After preparing the educational content of the intervention group, which will necessarily cover the contents of different areas of the nurse-patient caring interaction questionnaire, the materials will be provided to two specialist nurses with a PhD degree from the School of Nursing who will not formally cooperate with this study And its authenticity will be ensured. In the intervention group, in addition to the usual training, professional caring interaction training (according to the protocol designed by researchers based on relevant texts and research variables) will be provided to nurses Which include: definition of caring interaction, history about it, factors which influencing on a caring interaction, the impact of each area of the questionnaire on the caring interaction and vice versa, the impact of caring interaction on various aspects of treatment and disease and strategies for creating an appropriate caring interaction.
Category
Treatment - Other
2
Description
Control group: After describing the purpose of the study and obtaining informed consent, in the first session, the researcher presented a questionnaire including demographic characteristics of patients and caring nurse-patient interaction scale (patient-version) to patients with at least 3 days hospitalization at cardiac care units and a questionnaire including demographic characteristics of nurses and the caring nurse-patient interaction scale( nurse-version) to cardiac care unit nurses. The questionnaires will be completed, and again one month later, These questionnaires will be distributed and collected by a bachelor of science in nursing who is working in that cardiac care unit. The nurses in the control group will receive only the usual training( routine training) , and training in The field of caring interactions will not be provided to this group. It should be noted that at the end of the intervention, the training provided to the intervention group will be provided to the nurses of the control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Dr. Mahmod Nekoyimohgadam
Street address
Kosar boulevard , Shafa hospital
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Fax
+98 34 3211 5783
Email
shafahospital@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Reza Malek Pourafshar
Street address
Haftbagh alavi highway, Kerman University of Medical Science
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Fax
+98 34 3226 3857
Email
malekpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Roghayeh Mehdipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Haftbagh Alavi highway,Kerman University of Medical Science
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
rm41321@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Roghayeh Mehdipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Haftbagh Alavi highway,Kerman University of Medical Science
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
rm41321@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Roghayeh Mehdipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Haftbagh Alavi highway,Kerman University of Medical Science
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
rm41321@yahoo.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All unidentifiable data of the participants, study protocol, statistical analysis map, informed consent form, clinical study report, codes used in the analysis and data classification system can be shared.
When the data will become available and for how long
Immediately after publishing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
The source of the research should be stated and all ethical issues should be observed.
From where data/document is obtainable
anisbahreini1375@gmail.com
What processes are involved for a request to access data/document
After obtaining permission from all researchers, this research will be sent via email.