Determining the effect of nurse telephone counseling on the syndrome of patients with covid19
Design
The present study will be a simple randomized clinical trial in the control and intervention groups, which will be performed in the intensive care unit (ICU) of selected military hospitals in Tehran on the families of patients admitted with Quid 19 who are spontaneously breathing and not connected to the ventilator. The sample size is 40 people who will be placed in each group of 20 people according to the method of availability and having the conditions for entering the study. The first starting group for sampling the study is identified randomly by tossing a coin. Routine communication method is performed in the control group and in the intervention group is examined by telephone consultation.
Settings and conduct
This project is a clinical trial that is randomly divided into two groups of control and intervention. Samples will be from the special ward of Tehran Army Hospitals.
Participants/Inclusion and exclusion criteria
Families of patents with covid 19 patients admitted to thy intnseive care unit
Intervention groups
Families of patients with Covid 19 admitted to the intensive care unit of selected military hospitals who are eligible for inclusion in the study.
Main outcome variables
Family syndrome is a set of psychological and non-psychological symptoms (physical, social and spiritual) including: fear, sadness, fatigue, depressive symptoms and anxiety. this research To determine the effect of telephone counseling, the nurse will examine the family syndrome of patients with coronavirus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210809052125N1
Registration date:2021-10-26, 1400/08/04
Registration timing:registered_while_recruiting
Last update:2021-10-26, 1400/08/04
Update count:0
Registration date
2021-10-26, 1400/08/04
Registrant information
Name
Mehdi Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6696 0000
Email address
akbarinurse97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-19, 1400/07/27
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of The Effect of Telephone Consultation on The Syndrome of The Patients Family In Thy Intensive Care Unit With Covid 19
Public title
Evaluation of The Effect of Telephone Consultation on The Syndrome of The Patients Family In Thy Intensive Care Unit With Covid 19
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to enter the Plan
Do not use Anti_Anxiety Drugs and Sedatives
No Auditory or Visual Impairment
The Patient was Hospitalized for more 5 days in the Intensive Care Unit
Exclusion criteria:
Reluctance to continue cooperation
Occurrence of a critical event for a family member
Less than 72 hours in the intensive care unit
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by Tossing Coins
The sample size is 40 people who will be placed in each group of 20 people according to the method of availability and having the conditions for entering the study. The first starting group for sampling the study is identified randomly by tossing a coin. Routine communication method is performed in the control group and in the control group, the intervention is examined by telephone counseling method.
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
Ethics Committee of Aja University of Medical Sciences
Street address
No. 105, Kashan St.
City
Tehran
Province
Tehran
Postal code
1318918664
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.AJAUMS.REC.1400.066
Health conditions studied
1
Description of health condition studied
Family syndrome
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Family syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Family syndrome
Timepoint
Before the intervention begins _Fifth day _Day of discharge
Method of measurement
Lesk Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First in the experimental group, before the intervention and after the patient enters the ward of a form of personal information that includes age, sex, marital status, number of children, level of education, economic level, history of smoking, history of psychiatric drugs And the address of the residence is the history of hospitalization. We will complete it in five minutes. Counseling is provided by a researcher who has about ten years of experience in the intensive care unit, four years in the emergency department and six years in the psychiatric ward. The content of the training includes familiarity with covid disease and methods of treatment and familiarity with the environment and care in the special ward. Family questions are then answered. Counseling is done on the first day for a maximum of one hour and then 5 minutes a day by phone in the morning by the researcher and if necessary, the patient's family can call the researcher's mobile phone number. To take. Due to the visit ban, no visits are made by the family in order to prevent the spread of infection. In this study, for each patient, only one of the family members who is most involved in the patient care process is studied.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان 501، 503،خانواده
Full name of responsible person
مهدی اکبری
Street address
Imam Reza Hospital (501).Sarhang Etemadza .Fatemi St deh St.
City
Tehran
Province
Tehran
Postal code
1318918664
Phone
+98 21 6696 4157
Email
akbari_nurse97@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr. Azam Sajjadi
Street address
Shariati St., next to Aja Nursing School Family Hospital
City
Tehran
Province
Tehran
Postal code
1318918664
Phone
+98 21 6696 4157
Email
Akbari_nurse97@yahoo.com
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
Mehdi Akbari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No105,kashan st
City
Tehran
Province
Tehran
Postal code
1318918664
Phone
+98 21 6696 4157
Fax
Email
akbarinurse97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
mehdi akbari
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 105, Kashan St.
City
Tehran
Province
Tehran
Postal code
1318918664
Phone
+98 21 6696 4157
Email
Akbari_nurse97@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
mehdi Akbari
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 105, Kashan St.
City
Tehran
Province
Tehran
Postal code
1318918664
Phone
+98 21 6696 4157
Email
Akbari_nurse97@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
Not applicable
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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only the results of the research will be made available to the public and no information will be made public
When the data will become available and for how long
6 months after printing
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Aja School of Nursing
What processes are involved for a request to access data/document