Investigating the impact of the presence companion nurse program on the anxiety and physiological indicators of angiography candidate patients in the waiting room
This study investigated the effect of the accompanying nurse's presence program on angiography candidates' anxiety and physiological indicators In the waiting room.
Design
Two-group randomized clinical trial, randomized, on 70 patients, random allocation using Random allocation software
Settings and conduct
The environment of this research was the heart department and angiography waiting room of Razi Medical Education Center in Birjand affiliated to Birjand University of Medical Sciences and Health-Therapeutic Services.
In two stages, at the time of entering the waiting room and at the time of entering the angiography room, the accompanying nurse presence program was carried out for each patient individually in the intervention group.
Participants/Inclusion and exclusion criteria
Candidate patients for angiography
Inclusion criteria: age 25 to 85 years, angiography is not an emergency patient
Exclusion criteria: Life-threatening problems including rhythm disorders (arrhythmias), Waiting time of less than 20 minutes
Intervention groups
Intervention group: accompanying nurse attendance program
Control group: cath lab routine program
Main outcome variables
Reducing anxiety, reducing physiological index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230802059007N1
Registration date:2024-01-03, 1402/10/13
Registration timing:retrospective
Last update:2024-01-03, 1402/10/13
Update count:0
Registration date
2024-01-03, 1402/10/13
Registrant information
Name
sajjad salehian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3282 4317
Email address
sajjadsalehian@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of the presence companion nurse program on the anxiety and physiological indicators of angiography candidate patients in the waiting room
Public title
The effect of the presence companion nurse program on anxiety and physiological indicators of angiography candidate patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Angiography is not an emergency patient
Hospitalization in the relevant cardiac departments
Ability to communicate verbally
Being a candidate for an angiography procedure for the first time
Not having vision and hearing problems
No drug addiction
Avoid using sedatives
No epilepsy or mental illness
No high blood pressure
Not receiving anti-anxiety drugs before the procedure
Willingness to participate in the study and complete the written informed consent form
The patient is not part of the treatment team
Exclusion criteria:
Life-threatening problems including rhythm disorders (arrhythmias)
Waiting time of less than 20 minutes
Angiography for several times
Age
From 25 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, According to previous studies, The samples were first selected by the available sampling method and then randomly allocated using Random Allocation software in two intervention (A) and control (B) groups.
Therefore, for this purpose, first, the researcher introduced himself to the patients who met the criteria for entering the study, and explanations were given regarding the study and its objectives. Then, following all the ethical and scientific criteria, a list of candidate patients for angiography was prepared and numbered. The target sample was selected by random allocation. Explaining that the allocation of research units to two groups was done using random allocation software is necessary.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
This study has two groups (intervention and control). The cath lab routine program is carried out in the control group, but the presence companion nurse program is carried out in the intervention group. Only one type of intervention (the presence companion nurse program) is performed on patients in the intervention group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Approval date
2023-05-10, 1402/02/20
Ethics committee reference number
IR.BUMS.REC.1402.074
Health conditions studied
1
Description of health condition studied
Cardiovascular disease
ICD-10 code
I51.6
ICD-10 code description
Cardiovascular disease, unspecified
Primary outcomes
1
Description
anxiety
Timepoint
Measuring anxiety at the beginning of the study (before the start of the intervention) and after half an hour after the intervention
Method of measurement
Hamilton anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the presence companion nurse program -On the day of angiography, upon entering the waiting room, the patient's anxiety level and physiological indicators were determined, then the nurse's presence plan was implemented for the patient, after the intervention, when entering the angiography room, the patient's anxiety level and physiological indicators were rechecked. The presence companion nurse program was carried out for each patient individually in the intervention group. In this study, the companion nurse is the researcher. Also, the cath lab routine program was implemented in the control group. Just before entering the waiting room and also the angiography room, the Hamilton anxiety questionnaire was taken. Intervention: Introduction of cath lab space - introduction of personnel and a friendly and trusting atmosphere for the patient - explaining how to perform the angiography procedure in simple language - psychological support (being responsive to the patient's questions) - assuring the patient that we will wait for her until the end of the procedure
Category
Prevention
2
Description
Control group: cath lab routine program - also in the control group, the cath lab routine program was implemented. Before entering the waiting room and also the angiography room, the Hamilton anxiety questionnaire was taken. The routine program of the department is as follows: after patients are delivered by the ward nurse, the patient's information is checked, and the patients are checked for lack of equipment and dentures. Then, the patients wait for the angiography room to be empty.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Birjand Hospital
Full name of responsible person
Sajjad Salehian
Street address
South Khorasan, Birjand, Ghaffari Street, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 992 793 4130
Email
st.sajad73@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
research deputy of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5000
Email
webda@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Sajjad Salehian
Position
Master in nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 88, Shahid Rajaei Blvd
City
Tabas
Province
South Khorasan
Postal code
9791864746
Phone
+98 56 3282 4317
Fax
Email
sajjadsalehian@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Simin Sharafi
Position
Assistant Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5000
Email
Siminsharafi68@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Sajjad Salehian
Position
Master in nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 88, Shahid Rajaei Blvd
City
Tabas
Province
South Khorasan
Postal code
9791864746
Phone
+98 56 3282 4317
Fax
Email
sajjadsalehian@bums.ac.ir
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
Part of the data, such as information related to anxiety, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic institutions of medical sciences
Under which criteria data/document could be used
Research on angiography candidate patients
From where data/document is obtainable
sajjad salehian - st.sajad73@gmail.com
What processes are involved for a request to access data/document
After receiving the email, it will receive the data for one month.