Protocol summary

Study aim
Determining the effect of implementation of gratitude search strategy on outcomes related to early initiation in patients hospitalized in open heart surgery intensive care unit
Design
Clinical trial with a control group, with crossover groups, non-randomized on 98 patients.
Settings and conduct
Jamaran Hospital. In the control group, the clinical outcomes and accuracy of early initiation will be recorded by implementing the initiation of patients in the usual way without intervention. After that, a training session will be held for the nurses of Jamaran Hospital about the importance and early start-up method. After that, the data will be recorded using the tools at the same time as the early start-up of the patients.
Participants/Inclusion and exclusion criteria
nurses: * Superintendent, department deputy and shift managers * Experience of at least one year in the special care department patients: * Under open heart surgery * Left ventricular ejection fraction more than thirty percent nurses: * Failure to attend at least three-fourths of the gratefulness search workshop * Transfer to another department * Refusal to continue participating in the study patients: * Long-term mechanical ventilation of more than 24 hours * Drainage of more than 100 cc per hour in the second four hours after entering the open heart intensive care unit * Patients with neurological problems * Severe disturbance in the hemodynamic status and systolic pressure less than ninety millimeters of mercury * Receiving inotrope drugs * Duration of heart-pulmonary pump more than ninety minutes * Dying
Intervention groups
Nurses/patients undergoing open heart surgery
Main outcome variables
Appreciative Inquiry/Early mobilization quality/Pleural effusion/Atelectasis/spo2/Length of stay in open heart intensive care unit/Length of stay in the hospital/Vital signs/The amount of pain/drainage

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220817055735N1
Registration date: 2022-09-28, 1401/07/06
Registration timing: registered_while_recruiting

Last update: 2022-09-28, 1401/07/06
Update count: 0
Registration date
2022-09-28, 1401/07/06
Registrant information
Name
Mohammad Hosein Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3341 9429
Email address
mhs11677@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of implementing appreciative inquiry strategy on the outcomes associated with early mobilization in patients in open heart intensive care unit
Public title
The effect of implementing appreciative inquiry strategy on the outcomes associated with early mobilization in patients in open heart intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses: * Superintendent, department deputy and shift managers * Experience of at least one year working in the intensive care unit patients: * Under open heart surgery * No history of COPD and other chronic respiratory diseases * No movement problems * No neurological problems * No surgery At the same time, other than open heart surgery * the left ventricular ejection fraction is more than 30%
Exclusion criteria:
Nurses: * Absence of attending at least three-fourths of the grateful search workshop * Transfer to another department * Patients: * Long-term mechanical ventilation for more than 24 hours * Drainage of more than 100 cc per hour in the second four hours after admission to open heart special care department * severe disturbance in hemodynamic status and systolic pressure less than ninety mmHg * receiving inotrope drugs * duration of heart-pulmonary pump more than ninety minutes * death
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 98
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Baqiyatullah-ul-Azam (A.J.) Medical Education Center (Ethics in Research Committee)
Street address
Baqiyatallah university of medical sciences, Nosrati Ave, Mollasadra Ave, Vanak Sqr, Tehran
City
Tehran
Province
Tehran
Postal code
1873783558
Approval date
2022-07-25, 1401/05/03
Ethics committee reference number
IR.BMSU.BAQ.REC.1401.034

Health conditions studied

1

Description of health condition studied
outcomes associated with early mobilization
ICD-10 code
T82.8
ICD-10 code description
Other specified complications of cardiac and vascular prosthetic devices, implants and grafts

Primary outcomes

1

Description
Early mobilization quality
Timepoint
before and after intervention
Method of measurement
Early mobilization quality checklist

2

Description
Pleural effusion
Timepoint
before and after intervention
Method of measurement
The data collection form containing the results of the early launch

3

Description
Atelectasis
Timepoint
before and after intervention
Method of measurement
The data collection form containing the results of the early launch

4

Description
Oxygen saturation of arterial blood
Timepoint
before and after intervention
Method of measurement
The data collection form containing the results of the early launch

5

Description
Length of stay in the open heart intensive care unit/length of stay in the hospital
Timepoint
before and after intervention
Method of measurement
The data collection form containing the results of the early launch

6

Description
Vital sign
Timepoint
BEFORE AND AFTER INTERVENTION
Method of measurement
The data collection form containing the results of the early launch

7

Description
The amount of pain
Timepoint
BEFORE AND AFTER INTERVENTION
Method of measurement
The data collection form containing the results of the early launch

8

Description
The amount of drainage
Timepoint
BEFORE AND AFTER INTERVENTION
Method of measurement
The data collection form containing the results of the early launch

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: nurses working in the special care department of open heart surgery with managerial responsibility including the head of the department, his substitute and the shift managers with the aim of holding a workshop to search for volunteers / patients undergoing open heart surgery with the aim of implementing the early start-up protocol on them\After approving the title in the university and receiving the code of ethics, the necessary arrangements will be made with the hospital and the head of the open heart surgery department by referring to Jamaran Hospital and open heart special care department. Samples will be selected based on the inclusion criteria in a purposive approach. In the control group, the clinical outcomes and the accuracy of early initiation will be recorded by performing initiation of patients in the usual way without intervention.In the test group, an appreciation workshop will be held for the foreman, his deputy and shift managers. The standard worksheet of this workshop will be designed based on the four-stage cycle of gratefulness search in Fernald et al.'s study (20) and its translation steps will be completed. After that, a training session will be held for the nurses of Jamaran Hospital about the importance and early start-up method. After that, at the same time as the early initiation of the patients, the data will be recorded using the data collection form containing the clinical consequences of the early initiation and the quality checklist of the early initiation.
Category
Treatment - Surgery

2

Description
Control group: nurses working in the intensive care unit of open heart surgery with managerial responsibility including the head of the department, his deputy and the shift managers without holding a workshop to search for gratitude / patients undergoing open heart surgery without implementing the early start-up protocol on them\After approving the title in the university and receiving the code of ethics, the necessary arrangements will be made with the hospital and the head of the open heart surgery department by referring to Jamaran Hospital and open heart special care department. Samples will be selected based on the inclusion criteria in a purposive approach. In the control group, the clinical outcomes and the accuracy of early initiation will be recorded by performing initiation of patients in the usual way without intervention.In the test group, an appreciation workshop will be held for the foreman, his deputy and shift managers. The standard worksheet of this workshop will be designed based on the four-stage cycle of gratefulness search in Fernald et al.'s study (20) and its translation steps will be completed. After that, a training session will be held for the nurses of Jamaran Hospital about the importance and early start-up method. After that, at the same time as the early initiation of the patients, the data will be recorded using the data collection form containing the clinical consequences of the early initiation and the quality checklist of the early initiation.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Jamaran Hospital
Full name of responsible person
Mohammad Hosein Sadeghi
Street address
Jamaran Hospital, Tajrish sqr, Tehran
City
Tehran
Province
Tehran
Postal code
1873783558
Phone
+98 21 3341 9429
Email
mhs11677@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatollah University of Medical Sciences Research Division
Full name of responsible person
Abbasali Imani Foladi
Street address
Baqiyatallah university of medical sciences, Nosrati Ave, Mollasadra Ave, Vanak Sqr, Tehran
City
Tehran
Province
Tehran
Postal code
1873783558
Phone
+98 21 8126 0000
Email
mhs11677@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatollah University of Medical Sciences Research Division
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Hosein Sadeghi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Baqiyatallah university of medical sciences, Nosrati Ave, Mollasadra Ave, Vanak Sqr, Tehran
City
Tehran
Province
Tehran
Postal code
1873783558
Phone
+98 21 3341 9429
Email
mhs11677@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Hosein Sadeghi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Baqiyatallah university of medical sciences, Nosrati Ave, Mollasadra Ave, Vanak Sqr, Tehran
City
Tehran
Province
Tehran
Postal code
1873783558
Phone
+98 21 3341 9429
Email
mhs11677@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Hosein Sadeghi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Baqiyatallah university of medical sciences, Nosrati Ave, Mollasadra Ave, Vanak Sqr, Tehran
City
Tehran
Province
Tehran
Postal code
1873783558
Phone
+98 21 3341 9429
Email
mhs11677@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
The data contains the intended outcomes before and after the intervention
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in other studies with reference to the source
From where data/document is obtainable
mhs11677@gmail.com
What processes are involved for a request to access data/document
mhs11677@gmail.com
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