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The effect of information support on resilience, fear and anxiety of patients with COVID-19

Protocol summary

Study aim
Determining the effect of information support on resilience, fear and anxiety of patients with Covid 19
Design
Clinical trial with experimental and control groups, with parallel groups, without blinding, randomized on 84 patients. For randomization, permutation blocks were used by statistical software.
Settings and conduct
In this project, patients are fully informed about the process and objectives of the study before starting work. Then, the research intervention in the form of patient information support by the researcher in the form of individual, oral and face-to-face training for 4 30-minute sessions. It will be held daily in the morning shift at the patients' bedside located in Farshchian Hospital (Sina)
Participants/Inclusion and exclusion criteria
Inclusion criteria: It has been 48 hours since the patient was admitted. Definitive diagnosis of Covid 19 by an infectious disease specialist, Patients should be hospitalized for at least 7 days ,at least 18 years old, No neurological disease and mental illness and anxiety at the discretion of the treating physician, able to speak And understanding the Persian language,not using a ventilator,No communication problems Exclusion criteria: Reluctance to continue reading at any time, patient death, failure to complete information support sessions for any possible reason, creating new unwanted problems for the patient such as deterioration of the patient, use of ventilator, severe hemodynamic disorders, transfer of the patient to another ward
Intervention groups
The research intervention will be held in the form of individual patient support by the researcher in the form of individual, oral and face-to-face training and for 4 sessions of 30 minutes daily in the morning shift in the patient's bed. The control group will receive only routine ward care.
Main outcome variables
Resilience, Fear, Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170123032129N9
Registration date: 2021-01-05, 1399/10/16
Registration timing: registered_while_recruiting

Last update: 2021-01-05, 1399/10/16
Update count: 0
Registration date
2021-01-05, 1399/10/16
Registrant information
Name
Azim Azizi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
a.azizi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-10, 1399/09/20
Expected recruitment end date
2021-02-08, 1399/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of information support on resilience, fear and anxiety of patients with COVID-19
Public title
The effect of information support on patient's resilience, fear and anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
It has been 48 hours since the patient was admitted. Definitive diagnosis of Covid 19 by an infectious disease specialist Patients should be hospitalized for at least 7 days. At least 18 years old No neurological disease and mental illness and anxiety at the discretion of the treating physician Able to speak And understanding the Persian language Not using a ventilator No communication problems
Exclusion criteria:
Reluctance to continue reading at any time Death of the patient Failure to complete intelligence support sessions for any reason Creating new unwanted problems for the patient, such as worsening the patient's condition Use of ventilator Severe hemodynamic disorders Transfer of the patient to another ward
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: 84
Randomization (investigator's opinion)
Randomized
Randomization description
First, the samples will be selected as available. Then, using the permutation block method, they will be assigned to two groups of control and test. Thus, the experimental group will be marked with the letter A and the control group with the letter B. Six blocks of letters A and B will then be generated by the statistical software. Each block will be separated and placed in a bag. One of the samples is randomly selected from one of the blocks and the sequence in that block will be placed in the test and control groups. For example, BAAABB will be selected by one patient and the first person will be in the control group, the next three in the experimental group and the next two in the control group. In order to prevent the publication of the study, if one of the patients is in the second group in each room, the second patient will be eliminated due to the prevention of the publication of the study.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-08-09, 1399/05/19
Ethics committee reference number
IR.UMSHA.REC.1399.684

Health conditions studied

1

Description of health condition studied
Covid disease 19
ICD-10 code
U07.1
ICD-10 code description
COVID-19 confirmed by laboratory testing

Primary outcomes

1

Description
Resilience of patients with Covid 19
Timepoint
Before and 4 days after the intervention
Method of measurement
Connor and Davidson's resiliency scale

Secondary outcomes

1

Description
Fear of patients with Covid 19
Timepoint
Before and 4 days after the intervention
Method of measurement
Covid Fear Scale 19 Ahrsu

2

Description
Anxiety of patients with Covid 19
Timepoint
Before and 4 days after the intervention
Method of measurement
Spielberger Anxiety Inventory

Intervention groups

1

Description
Intervention group: The intervention of examination group will be held in the form of individual patient support by the researcher in the form of individual, oral and face-to-face training for 4 30-minute sessions daily in the morning shift in the patient's bedside, will be planned so that the program Be commensurate with the patient's desire (in terms of time) to have maximum participation in the program. Information support in the individual session will focus on the patient's main problems and tailored to his needs in order to take care of himself and obtain the necessary information about the disease to reduce the patient's anxiety and fear, and in subsequent sessions to discuss problems and concerns. We will pay the patient and answer their questions. Researcher information support includes general information about Covid 19 disease, its cause, explanation of various aspects of treatment, including adverse events, patient diet, complications of the disease and how to prevent them and equipment attached to the patient, heart condition and The lungs will be sick. Also, due to the fact that patients have mobile phones, the telephone number of the investigator will be provided to patients to ask their questions during the hospitalization. Dad. One day after the last intervention (morning 7) the patients of both groups will be given the manifest anxiety questionnaire and the Covid 19 fear and resilience scale again and the post-test will be performed.
Category
Rehabilitation

2

Description
Control group:Control group participants will receive only routine ward care.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Educational and Medical Center
Full name of responsible person
Azim Azizi
Street address
Mirzadeheshghi St. Farshchian Educational and Medical Center
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
a.azizi@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmide boulevard, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Azim Azizi
Position
PhD in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Science, Shahid Fahmide boulvard, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
a.azizi@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azim Azizi
Position
PhD in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Science, Shahid Fahmide boulvard, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
a.azizi@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azim Azizi
Position
PhD in nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
a.azizi@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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