Comparison of the effect of training on tracheotomy care using simulation and application methods on the anxiety and self-efficacy of the main caregivers of the patients admitted at home
Comparison of the effect of tracheostomy care training with simulation and application methods on anxiety and self-efficacy of primary caregivers of hospitalized patients at home
Design
Randomized clinical trial
Settings and conduct
The present study is a clinical trial. The study population included the main cargivers of patients admitted to intensive care units of hospitals affiliated to Tehran University of Medical Sciences, who were discharged by mechanical ventilation.
Participants/Inclusion and exclusion criteria
>60 years
Having an Android phone by someone close to the patient who is taking care of him
Ability to write and read
Willingness to participate in the study
First discharge with tracheostomy
Ability to understand and speak Persian
No hearing, touch, visual and speech disorders
Intervention groups
Intervention group 1: simulation in clinical setting
Intervention group 2: training via application
Main outcome variables
Anxiety
Self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111203008286N7
Registration date:2019-10-14, 1398/07/22
Registration timing:prospective
Last update:2019-10-14, 1398/07/22
Update count:0
Registration date
2019-10-14, 1398/07/22
Registrant information
Name
Fatemeh Bahramnezhad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
fatemeh_bahramnezhad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-20, 1398/08/29
Expected recruitment end date
2020-11-19, 1399/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of training on tracheotomy care using simulation and application methods on the anxiety and self-efficacy of the main caregivers of the patients admitted at home
Public title
training on tracheotomy care u
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
<65 years
Having an Android phone by someone close to the patient who is taking care of him
Ability to write and read
First discharge with tracheostomy
Willingness to participate in the study
No hearing, touch, visual and speech disorders
Ability to understand and speak Persian
Exclusion criteria:
The participnt's unwillingness to continue participating in the study
Age
To 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Research samples (main caregiver) with inclusion criteria will be divided into three groups using blocking method. There are 9 possible ways to equally assign participants to block. Allocation proceeds by randomly selection by randomization.com and after that participants enter 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
School of Nursing and Midwifery and Rehabilitation, Tehran University of Medical Sciences
Street address
School of Nursing and Midwifery, Tohid Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-07-14, 1398/04/23
Ethics committee reference number
IR.TUMS.FNM.REC.1398.083
Health conditions studied
1
Description of health condition studied
Anxiety and self-efficacy of the main caregiver
ICD-10 code
J95.85
ICD-10 code description
Complication of respirator [ventilator]
Primary outcomes
1
Description
Anxiety: In this study, anxiety of caregivers of patients with tracheostomy will be measured one month after intervention.
Timepoint
One month after intervention
Method of measurement
Hamilton Anxiety Rating Scale (HAM-A)questioner
2
Description
Self-efficacy: In this study, self-efficacy of caregivers of patients with tracheostomy will be measured one month after intervention.
Timepoint
One month after intervention
Method of measurement
Caregiver Inventory(CGI)questioner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After getting informed consent, anxiety and self-efficacy questionnaires will be given to the samples and then the application will be installed on their mobile phones and their levels of anxiety and self-efficacy will be measured a month later .
Category
Behavior
2
Description
Intervention group2:After getting informed consent, the anxiety and self-efficacy questionnaires were given to the samples, and exactly the same educational content as trained for the application group, in three 15-minute sessions and in the final three days before discharge to the hospital in the center. The clinical skills training of the Tehran School of Nursing and Midwifery will be taught to the patient's primary caregiver. Then, one month after clearing their anxiety levels and self-efficacy will be measured.
Category
Behavior
3
Description
Control group: At first, informed consent forms, anxiety and self-efficacy questionnaires will be completed, will receive routine care, and will be completed one month after the anxiety and self-efficacy questionnaire is discharged. After studying the educational content they will be provided
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomini Hospital
Full name of responsible person
Fatemeh Bahramnezhad
Street address
School of Nuring and Midwifery, Tohid Sq., Tehran, IRan
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4416
Email
bahramnezhad.f@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
DR. Sahraian
Street address
Tehran University of Medical Sciences, Keshavarz Blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
144567889
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bahramnezhad
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nuring and Midwifery, Tohid Sq.,Tehran, IRan
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4416
Email
bahramnezhad.f@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bahramnezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nurisng and Midwifery, Tohid Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4146
Email
bahramnezhad.f@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bahramnezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tohid Sq., Tehran, IRan
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4416
Email
bahramnezhad.f@gmail.com
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