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The Effect of Supportive Training Program on Depression and Anxiety and Satisfaction of Families of Patients with Acute Coronary Syndrome Admitted to the Cardiac Care Unit

Protocol summary

Study aim
Determining the effect of supportive educational program on depression, anxiety and satisfaction of families of Patients with acute coronary syndrome admitted to the cardiac care unit
Design
Clinical trial with community based and pragmatic control group, with parallel group, without blindness, Randomized by SPSS software
Settings and conduct
families of patients with acute coronary syndrome admitted to the cardiac care unit of Imam Reza and Ghaem Hospital who are eligible for the study will be included in the study and will be randomly selected and assigned to the intervention and control groups according to the sequences that generated by SPSS software. In the intervention group a supportive educational program is implemented.The intervention is performed from the day of admission and lasts up to 3 days in the cardiology ward.In the control group, patients family will receive routine treatment.anxiety,depression will be checked before and after the intervention with DASS questionnaire. and also satisfaction questionnaire will be completed after the intervention in both groups
Participants/Inclusion and exclusion criteria
Patient including criteria: Definitive Diagnosis of Acute Coronary Syndrome Patient's family including criteria:Being first-degree members of the family, Fluency in Persian, having no history mental disorders, having at least primary education, not having health care jobs, not taking care of another person at the same time, having no history of admission to the cardiac care unit, and having no audible and visual problems.
Intervention groups
In the intervention group, a Supportive Training Program will be performed for 72 hours for the family of patients with acute coronary syndrome admitted to the cardiac care unit. In the control group, patients family will receive routine manner.
Main outcome variables
Level of Depression, anxiety and satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181101041524N1
Registration date: 2019-07-08, 1398/04/17
Registration timing: registered_while_recruiting

Last update: 2019-07-08, 1398/04/17
Update count: 0
Registration date
2019-07-08, 1398/04/17
Registrant information
Name
Fateme Faroujizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
faroujizadehf951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-15, 1398/03/25
Expected recruitment end date
2019-09-16, 1398/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Supportive Training Program on Depression and Anxiety and Satisfaction of Families of Patients with Acute Coronary Syndrome Admitted to the Cardiac Care Unit
Public title
The Effect of Supportive Training Program on Depression and Anxiety and Satisfaction of Families of Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Including criteria for patient:Diagnosis of acute coronary heart disease by clinical signs, ECG and enzyme tests approved by the cardiologist Including criteria for patient family:First-class members of the family of patients admitted to the cardiac care unit according to the patient's choice Primary education Fluency in Persian
Exclusion criteria:
History of hospitalization in ccu ward Having health care jobs Having a visual and audio problem Take care of another person at the same time Having a history of illness and mental disorders based on the patient's history and self-declaration
Age
From 18 years old to 70 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
The research units according to the sequences that generated by SPSS software before the start of the study were randomly divided into intervention and control groups. In order to prevent the dissemination of information between the two group,until the patients selected for the first group are not discharged from the ward, sampling for the second group will not take place.
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Opposite University Street 18-University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137654511
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.007

Health conditions studied

1

Description of health condition studied
Acute coronary syndrome
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease

Primary outcomes

1

Description
depression
Timepoint
At the time of admission and 72 hours after admission
Method of measurement
Depression, Anxiety and stress Scales( DASS)

2

Description
the amount of anxiety
Timepoint
At the time of admission and 72 hours after admission
Method of measurement
Depression, Anxiety and stress Scales( DASS)

3

Description
Satisfaction of family members of hospitalized patients
Timepoint
72 hours after admission
Method of measurement
Family Satisfaction in the Intensive Care Unit FS-ICU (34)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The educational and supportive program will be implemented, which will include the educational, support and counseling needs of the patient's family in this program.The intervention will be implemented from the patient's Hospitalization day in the CCU ward and will continue for up to 3 days in the cardiology ward.The supportive program includes information support and emotional support.In this way, in the emotional support from the time of admission, the researcher will be with family members and while performing psychological support from them, she describes the patient's condition and listens to their words and she Reassures them about the patient's care and answer questions, concerns and express their feelings and It also considers a scheduled visit to the patient's family; this is the case during the period of admission to the cardiac care unit, after the patient is in a stable position, the patient's companion can meet his patient once a day.Meetings will be scheduled according to need of companion and patient.The family will be taught to control their feelings and use promising and hopeful words to calm the patient.In support of information the patient family will be informed about the patient's condition and vital signs daily and during this time the researcher will answer the patient's family questions and concerns.In the training program, the CCU ward, equipment, patient connections, the nature of the disease and the treatment process will be explained.These trainings will be face-to-face and educational pamphlets will be given to the family.When treatment is required, a description of the treatment options will be provided about the benefits and complications of each treatment.These trainings take place in a room and in a quiet environment for 40 minutes in coordination with the head nurse to determine the training room.Finally, on the third day of hospitalization in the cardiology ward, post-discharge care, such as proper diet, proper physical activity, and regular use of medications, will be trained for a maximum of 45 minutes plus pamphlets.The number of training sessions during the hospital stay is scheduled according to the need for attendance, in which at least two training sessions are held during these three days of intervention.
Category
N/A

2

Description
Control group: control group will receive the usual care, so that at the beginning of the patient's stay, a welcome pamphlet is given to the family, which includes information on the rules and environment of the ward, telephone number and hours of the visit.Information is also given to the patient's family upon request from the family regarding the patient's condition.At the discharge time, information is provided to the patient about the diet, medications and physical activity, along with educational pamphlets.Routine training in hospitals is general and does not need to be performed based on the needs of the patient's family.There is no advice on the types of treatments and only information about the ACS disease care and cardiac care unit is provided to all patients in the form of a pre-prepared training pamphlet
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Quaem hospital
Full name of responsible person
Fateme Hajiabadi
Street address
Beginning at Ahmadabad Street,Dr. Ali Shariati Square,
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Fax
+98 51 3845 3239
Email
Quaem.Medical.Center@mums.ac.ir
Web page address
http://quaem.mums.ac.ir

2

Recruitment center
Name of recruitment center
Emam reza hospital
Full name of responsible person
Fateme Hajiabadi
Street address
Imam Reza Hospital Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
+98 51 3854 3039
Email
Emamreza@mums.ac.ir
Web page address
http://emamreza.mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vpresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Faroujizadeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ebne Sina Street, University Blvd Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
faroujizadehf951@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
fateme faroujizadeh
Position
Master of Science in Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ebne Sina Street, University Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
faroujizadehf951@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
fateme faroujizadeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ebne Sina Stree, University Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
faroujizadehf@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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