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The effect of supportive role of nurse on stress, anxiety and depression in the hospitalized elderly with COVID-19 in Firoozabadi hospital at Rey city

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History
# Registration date Revision Id
2 2022-10-21, 1401/07/29 247029
1 2022-08-12, 1401/05/21 236246
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  • General information

    empty
    The address and information I have entered has changed
    empty
    آدرس و مشخصاتی که وارد نموده ام، تغییر کرده است.

  • Recruitment centers

    #1
    Name of recruitment center - English: Firoozabadi hospital at Rey city
    Name of recruitment center - Persian: بیمارستان فیروزآبادی شهرری
    Full name of responsible person - English: Dr. Soheila Mahdavinia
    Full name of responsible person - Persian: دکتر سهیلا مهدوی نیا
    Street address - English: Tehran_Rey_ Fadaeianeslam St.
    Street address - Persian: تهران_ ری_ خیابان فداییان اسلام
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1816111915
    Phone: +98 21 5651 5229
    Fax:
    Email: hospfa@iums.ac.ir
    Web page address: https://hospfa.iums.ac.ir/
    Name of recruitment center - English: Firoozabadi hospital at Rey city
    Name of recruitment center - Persian: بیمارستان فیروزآبادی شهرری
    Full name of responsible person - English: Dr. Soheila Mahdavinia
    Full name of responsible person - Persian: دکتر سهیلا مهدوی نیا
    Street address - English: Tehran_Rey_ Fadaeianeslam St.
    Street address - Persian: تهران_ ری_ خیابان فداییان اسلام
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1331853859
    Phone: +98 21 5651 5229
    Fax:
    Email: hospfa@iums.ac.ir
    Web page address: https://hospfa.iums.ac.ir/

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: sُhahriar Bijani
    Full name of responsible person - Persian: شهريار بيژني
    Street address - English: Research Vice Presidency Office, Central Building, Shahed University, Opposite Holy Shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran.
    Street address - Persian: تهران - ابتدای آزاد راه تهران قم - روبروی حرم مطهر امام خميني دانشگاه شاهد- سازمان مركزي -معاونت پژوهشي ینی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 33191​18651
    Phone: +98 21 5121 3092
    Fax: +98 21 5121 3190
    Email: research@shahed.ac.ir
    Web page address: http://shahed.ac.ir

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shahriar Bijani
    Full name of responsible person - Persian: شهريار بيژني
    Street address - English: Research Vice Presidency Office, Central Building, Shahed University, Opposite Holy Shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran.
    Street address - Persian: تهران - ابتدای آزاد راه تهران قم - روبروی حرم مطهر امام خميني دانشگاه شاهد- سازمان مركزي -معاونت پژوهشي ینی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 33191​18651
    Phone: +98 21 5121 3092
    Fax: +98 21 5121 3190
    Email: research@shahed.ac.ir
    Web page address: http://shahed.ac.ir

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hanie Sayadian
    Full name of responsible person - Persian: حانیه صیادیان
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kahrizak_Shahid Beheshti Blvd._Golestan Ave_No 27
    Street address - Persian: کهریزک_بلوار شهید بهشتی_کوچه گلستان _پلاک ۲۷ واحد ۱
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1816111915
    Phone: +98 21 5651 5229
    Mobile: +98 919 585 3122
    Fax:
    Email: Zasa70901@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hanie Sayadian
    Full name of responsible person - Persian: حانیه صیادیان
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Tehran_Ghazvin Ave._Mirjalily Ave_No 22
    Street address - Persian: تهران_خیابان قزوین_خیابان میرجلیلی_پلاک 22
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1331853859
    Phone: +98 918 691 4710
    Mobile: +98 919 585 3122
    Fax:
    Email: Zasa70901@yahoo.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hanie Sayadian
    Full name of responsible person - Persian: حانیه صیادیان
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid beheshti blv
    Street address - Persian: بلوار شهید بهشتی
    City - English: Kahrizak
    City - Persian: کهریزک
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1816111915
    Phone: +98 918 691 4710
    Mobile: +98 919 585 3122
    Fax:
    Email: Zasa70901@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hanie Sayadian
    Full name of responsible person - Persian: حانیه صیادیان
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghazvin
    Street address - Persian: قزوین
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1331853859
    Phone: +98 918 691 4710
    Mobile: +98 919 585 3122
    Fax:
    Email: Zasa70901@yahoo.com
    Web page address:

Protocol summary

Study aim
Determining and comparing the effect of nurse supportive role on stress, anxiety and depression in the elderly with COVID- 19 admitted to Firoozabadi Hospital in Rey
Design
Non-randomized controlled trials was conducted with 78 subjects (39 in each group) .
Settings and conduct
In this study, 78 eligible elderly persons hospitalized in Firouzabadi Hospital were divided into group of experimental and control group (39 in each group). The control group received routine general patient education. The experimental group, in addition to routine general patient education, received informational, emotional-spiritual and social support implementations by the researcher from 2nd to 5th day of hospitalization, daily, 8 - 10 AM (for one hour). Before the intervention and after the intervention, on the fifth day of hospitalization , Depression Anxiety and Stress Scale 21 (DASS-21) was completed in both experimental and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Age over 60 years based on patient record , patient with COVID-19 on first day of hospitalization ,ability to dialect and understanding of Persian language score 7 or higher on abbreviated mental test (AMT). non- inclusion criteria include: history of depression and psychological problems under medication according to information ,previous history of hospitalization due to COVID- 19 disease, use of barbiturates and anti-anxiety drugs during hospitalization
Intervention groups
Implementation of support in informational, spiritual, emotional and social fields daily and during the five days of hospitalization of the elderly patients 8 - 10 am (for one hour).
Main outcome variables
Stress, Anxiety and Depression

General information

Reason for update
The address and information I have entered has changed
Acronym
IRCT registration information
IRCT registration number: IRCT20220609055119N1
Registration date: 2022-08-12, 1401/05/21
Registration timing: retrospective

Last update: 2022-11-27, 1401/09/06
Update count: 1
Registration date
2022-08-12, 1401/05/21
Registrant information
Name
Hanie Sayadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 691 4710
Email address
zasa70901@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-16, 1400/12/25
Expected recruitment end date
2022-04-17, 1401/01/28
Actual recruitment start date
2022-03-16, 1400/12/25
Actual recruitment end date
2022-04-17, 1401/01/28
Trial completion date
2022-04-17, 1401/01/28
Scientific title
The effect of supportive role of nurse on stress, anxiety and depression in the hospitalized elderly with COVID-19 in Firoozabadi hospital at Rey city
Public title
The effect of supportive role of nurse on stress, anxiety and depression in the hospitalized elderly with COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years Being infected with COVID-19 Patient consent for participating in the study Getting 7 score or higher at abbreviated mental test(AMT ) First time hospitalized due to COVID-19 disease Dialect and understanding of Persian language The first day of hospitalization
Exclusion criteria:
Taking barbiturates and anti-anxiety or psychoactive drugs History of depression and psychological problems under treatment
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Actual sample size reached: 78
Randomization (investigator's opinion)
Not randomized
Randomization description
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 committe of shahed university
Street address
Shahed University, Opposite Holy Shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
33191​18651
Approval date
2022-03-05, 1400/12/14
Ethics committee reference number
IR.SHAHED.REC.1400.172

Health conditions studied

1

Description of health condition studied
Depression,Anxiety,Stress
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Stress
Timepoint
The first day (before intervention) and the fifth day of hospitalization (after intervention).
Method of measurement
Questionnaire 21 questions of stress, anxiety and depression

2

Description
Anxiety
Timepoint
The first day (before intervention) and the fifth day of hospitalization (after intervention).
Method of measurement
Questionnaire 21 questions of stress, anxiety and depression

3

Description
Depression
Timepoint
The first day (before intervention) and the fifth day of hospitalization (after intervention).
Method of measurement
Questionnaire 21 questions of stress, anxiety and depression

Secondary outcomes

empty

Intervention groups

1

Description
Control group: The patients received routine general education.
Category
Other

2

Description
Intervention group: In addition to receiving general routine training , the subjects received informational, spiritual, emotional and social support from 2nd day to 5th day of hospitalization during one hour, 8 - 10 AM, daily.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozabadi hospital at Rey city
Full name of responsible person
Dr. Soheila Mahdavinia
Street address
Tehran_Rey_ Fadaeianeslam St.
City
Tehran
Province
Tehran
Postal code
1331853859
Phone
+98 21 5651 5229
Email
hospfa@iums.ac.ir
Web page address
https://hospfa.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Shahriar Bijani
Street address
Research Vice Presidency Office, Central Building, Shahed University, Opposite Holy Shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
33191​18651
Phone
+98 21 5121 3092
Fax
+98 21 5121 3190
Email
research@shahed.ac.ir
Web page address
http://shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
20
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
Shahed University
Full name of responsible person
Hanie Sayadian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran_Ghazvin Ave._Mirjalily Ave_No 22
City
Tehran
Province
Tehran
Postal code
1331853859
Phone
+98 918 691 4710
Email
Zasa70901@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nasrin Alaee
Position
Assoistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite Holy Shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1816111915
Phone
+98 21 5121 2130
Fax
Email
alaei@shahed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Hanie Sayadian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghazvin
City
Tehran
Province
Tehran
Postal code
1331853859
Phone
+98 918 691 4710
Fax
Email
Zasa70901@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The form of personal information including age, sex, marriage, number of children, level of education, income level, cohabitation status, underlying diseases and drugs used and percentage of lung involvement is available without mentioning patients' names and logos. A summary of how the research was conducted and its duration is available. results of 21-item questionnaire on depression, anxiety; stress is available.
When the data will become available and for how long
After defending the thesis
To whom data/document is available
Students and researchers
Under which criteria data/document could be used
Research in a field similar to current research
From where data/document is obtainable
Visit the website of Shahed University or send a message to researcher's email. Zasa7090@yahoo.com
What processes are involved for a request to access data/document
It can be downloaded from the library of university .
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