Protocol summary

Study aim
Determining the effect of the role of the emergency liaison nurse on anxiety, satisfaction with medication adherence in cardiac patients who referred to the emergency room of AJA selected hospitals in Shahranharan in 1402
Design
A randomized controlled clinical trial, before and after
Settings and conduct
The research was carried out in the emergency department of Golestan Hospital in Tehran by a researcher (liaison nurse) with 18 years of experience working in cardiac departments on cardiac patients. Intervention, psychological and educational support and... completion of anxiety questionnaires before and after the intervention and satisfaction after the intervention and completion of the medication compliance questionnaire after two weeks in the group. Intervention and completion of the same questionnaires without control in the test group, and then comparison in the test and intervention group
Participants/Inclusion and exclusion criteria
Cardiac patients who refer to the emergency room who take medicine - patients who are under 18 and over 65 years old, and neuropsychiatric patients
Intervention groups
Cardiac patients who refer to the emergency room, where the nurse accompanies them from the moment they arrive until they are discharged from the emergency room, and provides them with services such as emotional support training and the necessary guidance.
Main outcome variables
Anxiety, satisfaction, medication compliance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231002059585N1
Registration date: 2024-01-26, 1402/11/06
Registration timing: prospective

Last update: 2024-01-26, 1402/11/06
Update count: 0
Registration date
2024-01-26, 1402/11/06
Registrant information
Name
Fatemeh Vafaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2637 4824
Email address
fatemehvafaee135@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-04, 1402/11/15
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the role pf liaison nurse on anxiety ,satisfaction and medication adherence in cardiac patients referring to the emergency ward of selected Aja hospital in Tehran
Public title
Investigating the effect of liaison nurse on satisfaction ,anxiety and medication compliance in cardiac patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18and over 65 years old Awere of time and place Not having mental illness and not having cognitive problems(Based on self-report) Going to the emergency room due to heart problems and taking heart medications
Exclusion criteria:
Free cancellation of cooperation Occurrence of unpredictable events during the transfer process(such as cardiorespiratory arrest and patient resuscitation)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random assignment(coin toss)Simple random allocation (tossing a coin), and sampling will be of an easy type (accessible), so if the coin is tossed and it lands on the tap, the first patient who goes to the emergency room who meets the conditions of the research is considered the intervention group and the next patient of the test, and vice versa, if it lands on the line, the second patient is the intervention and the first patient. The test is considered, and until the last sample, we consider an intervention patient and a test patient, respectively, until the end of the samples.
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
دانشگاه علوم پزشکی ارتش
Street address
تهران خیابان فاطمی غربی_خیابان شهید اعتماد زاده
City
تهران
Province
Tehran
Postal code
1411718541
Approval date
2023-08-28, 1402/06/06
Ethics committee reference number
IR.AJAUMS.REC.1402.094

Health conditions studied

1

Description of health condition studied
Cardiac patients referred to the emergency room who have a history of drug use
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
anxiety
Timepoint
At least an hour
Method of measurement
Spielberger anxiety questionnaire

Secondary outcomes

1

Description
satisfaction
Timepoint
From an hour to a day
Method of measurement
The satisfaction questionnaire of Wolf et al

2

Description
Moriski medication adherence
Timepoint
two weeks
Method of measurement
Moriski medication adherence questionnaire

Intervention groups

1

Description
Intervention group: Cardiac patients referred to the emergency room who do meet the conditions for the study were selected from the beginning of entering the emergency room, and after explaining the method and objectives of the study to them and their companions, written informed consent was obtained, and before the intervention, demographic and personal information was taken, and the anxiety questionnaire number 1 was placed in the patient's possession and completed, then the liaison nurse began to The intervention, which includes two parts of psychological support to reduce anxiety and increase the level of satisfaction and... and the other part of educational support and giving awareness about the disease, treatments, and the use of drugs, etc., is carried out, and then when being discharged or transferred to the inpatient department, the anxiety questionnaire 2 Next) it will be filled by the patient, then the patient will be monitored and supported by phone for 2 weeks. After 2 weeks, the medication compliance questionnaire is asked and filled by the researcher over the phone.
Category
Other

2

Description
Control group: In this group, only at the beginning of the selection of the patient who is willing to study, sufficient explanations are given to the patient about the method and objectives of the study, and first, written informed consent and demographic and personal information are obtained, and the anxiety questionnaire is filled in by the patient, and no intervention is performed during the discharge of the patient. After leaving the emergency department for hospitalization, the anxiety questionnaire and the satisfaction questionnaire are filled out, and then 2 weeks later, the medication compliance questionnaire is filled out by phone.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital Emergency
Full name of responsible person
Fatima Wafai
Street address
Tehran, Pasdaran CrossroadShirazi Highway, Golestan Nadaja Hospital
City
Tehran
Province
Tehran
Postal code
1668619551
Phone
+98 21 2254 9002
Fax
+98 21 2254 9096
Email
biseton67@gmail.com
Web page address
https://golestan.ajaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
رضا مساعد
Street address
West Fatemi Street, Shahid Etemadzadeh Street, Army University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
biston67@gmail.com
Web page address
https://www.ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Fatama Wafai
Position
Senior nursing student nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, Azgol neighborhood, Asharghi Burj Hor, No. 12, Unit 23
City
Tehran
Province
Tehran
Postal code
1695839830
Phone
+98 21 2637 4828
Email
fatemehvafaee135@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Nahid Rajaei
Position
Nursing instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shariati St., in front of Baharshiraz St., Kaj St., next to Army Family Hospital, Army School of Nursing
City
Tehran
Province
Tehran
Postal code
1615116139
Phone
+98 21 7750 0929
Email
N.Rajai22@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Fatama Wafai
Position
Senior nursing student nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ezgol neighborhood, Eastern waterfall, Borj Hor, No. 12, Unit 23
City
Tehran
Province
Tehran
Postal code
1695839830
Phone
+98 21 2637 3824
Email
fatemehvafaee135@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
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
spss file of data
When the data will become available and for how long
22/08/2024
To whom data/document is available
all people such as samples and researchers
Under which criteria data/document could be used
In order to check the accuracy of the data and the analyzes performed, the data will be provided to the journal in which the article will be published. Apart from this, the research team does not consider other special conditions
From where data/document is obtainable
By emailing the responsible author of the article: fatemehvafaee135@gmail.com MOBILE:09126349447
What processes are involved for a request to access data/document
In order to check the accuracy of the data and the analyzes performed, the data will be provided to the journal in which the article will be published. Apart from this, the research team does not consider other special conditions
Comments
Loading...