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The effect of planned online video meeting on anxiety, depression and satisfaction of patients in the open heart intensive care unit

Protocol summary

Study aim
Determining the effect of planned online video meeting on anxiety, depression and satisfaction of patients in the in the open heart intensive care unit
Design
A randomized clinical trial has a control group. The type of randomization is the time block. The sample size consists of 60 patients.
Settings and conduct
The Place of study is open heart ICU of Imam Reza Hospital of Mashhad. After obtaining written consent, In the intervention group, on the first and second day of hospitalization in the open heart ICU, video call establish in morning, evening and night shifts, and each shift for 10-15 minutes between the patient and the patient's family by a researcher tablet in the department and family smartphone o done. In the control group, routine care will be done without any visits within 48 hours of ICU admission.
Participants/Inclusion and exclusion criteria
Inclusion criteria is Having informed consent of patients, Age between 18 and 75 years, Being patient consciousness, The possibility of verbal communication, Having a smartphone connected to the internet by the patient family and Having reading and writing skills. Patients whose hemodynamic status is unstable, Patients with a history of known anxiety and depression problems
Intervention groups
In the intervention group, online video meeting done between the patient and the family. The control group will not meet during bedrid in the Open Heart Intensive Care Unit
Main outcome variables
The degree of anxiety and depression of the patient before the open heart surgery, 24 and 48 hours after admission to the ICU, the degree of satisfaction of the patient and his family with the Online video meeting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190705044105N1
Registration date: 2019-12-10, 1398/09/19
Registration timing: retrospective

Last update: 2019-12-10, 1398/09/19
Update count: 0
Registration date
2019-12-10, 1398/09/19
Registrant information
Name
Hossein Shahdosti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 8513
Email address
hosseinshahdosti@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-07, 1398/05/16
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of planned online video meeting on anxiety, depression and satisfaction of patients in the open heart intensive care unit
Public title
The effect of planned online video meeting on anxiety, depression and satisfaction of patients in the open heart intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent Performing a heart surgery for the first time age between 75 and 18 years Being patient consciousness Having verbal communication Having a smartphone connected to the internet by the patient family Having reading and writing skills
Exclusion criteria:
Patients with unstable hemodynamic status Having a history of anxiety and depression
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a random block of time.Hospitalized patients family were randomly divided into two groups (test and control) using random sequence generated by SPSS software.Such that the data file contains a number with a row variable 1-12 Generates and is selected by Random-select fifty percent of the numbers.Based on the previous draw, The numbers selected are a and the numbers omitted are b, which represent the intervention and control groups, respectively.Twenty-one blocks per week were randomly assigned to the intervention and control groups.This generated sequence was kept in a closed envelope and from the beginning of sampling at the beginning of each week it was determined which group of patients would be eligible for that week.
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
Ebne Sina St, Doctora Intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-07-27, 1398/05/05
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.038

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

2

Description of health condition studied
depression
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate

Primary outcomes

1

Description
Depression Score in Hospital Anxiety and Depression Inventory
Timepoint
Measure depression before open heart surgery and 24 and 48 hours after admission to the open heart Icu
Method of measurement
Hospital Depression Inventory HADS

2

Description
Anxiety Score in Hospital Anxiety and Depression Inventory
Timepoint
Measure Anxiety before open heart surgery and 24 and 48 hours after admission to the open heart Icu
Method of measurement
Hospital Anxiety Inventory HADS

3

Description
The patient's satisfaction score from the type of meeting in the researcher-made questionnaire
Timepoint
48 hours after admission to open heart Icu
Method of measurement
Researcher-made meeting satisfaction questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After the operation and transfer of the patient to the ICU open heart section, provided the patient is alert, on the first and second day of ICU Admission, online video call in morning, evening and night shifts between patient and family The patient is done. Online video call between the patient and her family is performed three times a day for 10-15 minutes with the researcher's tablet and the patient's family smartphone.
Category
Prevention

2

Description
Control group: In the control group, routine care is performed without any direct communication between the patient and the family during ICU Admission, and only the patient's status is reported to the family by the nurse.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital of Mashhad
Full name of responsible person
seyed reza mazlom
Street address
Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
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
Daneshgah street, mashahd university of medical sciences
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 2081
Email
vcresearch@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
Hossein Shahdosti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebne sina Street, doctora Intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3852 8513
Fax
Email
hosseinshahdosti@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Shahdosti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebne sina Street, doctora Intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
hosseinshahdosti@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Shahdosti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebne sina Street, doctora Intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3852 8513
Fax
Email
hosseinshahdosti@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
In this research, all the data of the people can be shared after Unrecognizable information. This data includes demographic data and information about the main outcome.
When the data will become available and for how long
The access period begins in 2020
To whom data/document is available
The data of this study will be available to both researchers working in Academic institutions and industry.
Under which criteria data/document could be used
Use is permitted for clinical and industrial research.
From where data/document is obtainable
People can get the data by this ways: Postal Address: Faculty of Nursing and Midwifery, Ebne Sina St, Doctora Intersection Mashhad, Iran Email Address: Shahdoustih961@mums.ac.ir, Mazlomr@mums.ac.ir phone number: 00989372537141 Hossein Shahdosti
What processes are involved for a request to access data/document
After requesting data, first their identity and organizational affiliation is checked, and after approval by the University Research Council, which usually takes two weeks, the data is provided to them.
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