Protocol summary

Study aim
Determining and comparing the level of thirst in patients undergoing heart surgery before and after the intervention Determining and comparing nausea and vomiting in patients undergoing heart surgery before and after the intervention Determining and comparing discomfort in patients undergoing heart surgery before and after the intervention
Design
Multi-stage sampling available and random allocation. After checking the inclusion criteria, patients are allocated to test and control groups using blocks of four. The sample size of this research, using Altman's nomogram, taking into account the significance level of α = 5% (type 1 error) and ß = 10% (type 2 error) and power = 90% (power of the study) and the results of similar studies (46), the number The required sample for each group was estimated to be 44 people, with a probability of 5% attrition, the sample size for each group was calculated to be 46 people. A total of 92 patients will be selected from the cardiac surgery patients to participate in the study groups and will be randomly assigned to two groups. In this way, 46 people will be placed in the test group and 46 people in the control group
Settings and conduct
jamaran heart hospital
Participants/Inclusion and exclusion criteria
Patients who are candidates for heart surgery
Intervention groups
The test group received the care package for the prevention of gastrointestinal complications after heart surgery The care package is a non-pharmacological intervention that has been collected by reviewing a range of relevant researches and has been approved by special care specialists. The control group received routine ward care
Main outcome variables
nausea vomiting feeling comfort - thirsty distress thirst

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240604062008N1
Registration date: 2024-06-26, 1403/04/06
Registration timing: prospective

Last update: 2024-06-26, 1403/04/06
Update count: 0
Registration date
2024-06-26, 1403/04/06
Registrant information
Name
Seyed Mohammadjavad Shahabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 0060
Email address
mj.shahabi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2024-08-05, 1403/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of the bundle care for the prevention of gastrointestinal complications after heart surgery
Public title
Bundle care for preventing Gastrointestinal Complication after Cardiac surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for non-emergency heart surgery Male or female, Adults,between the ages twenty-five and seventy-five. Patients who have the ability to communicate. Ejection fraction above 30% Have the ability to swallow
Exclusion criteria:
Having severe hyperthyroidism The occurrence of any severe surgical or life-threatening complications such as kidney failure Occurrence of severe ileus after surgery
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
In order to select research samples, in the first stage according to the entry criteria, available sampling and then random allocation with blocks of four will be used. In this way, the letter A will be assigned to the intervention group and the letter B will be assigned to the control group, and in blocks of four with the letters A and B, six states AABB, BBAA, ABAB, BABA, ABBA and BAAB in separate sheets. It will be written and thrown in a container. Randomly, one of these sheets is taken out of the container and we write the composition written on it, and then that sheet will be thrown into the container. This action will be repeated twenty-three times and each time the composition written on each sheet will be written in the sequence of the composition written on the previous sheet. Then, each letter was assigned a number from one to ninety-two, in the order of the letters written down one after the other, and each letter was placed in an envelope, and the number of that letter will be written on the envelope. Each time a disease is selected, one of these envelopes will be opened in the order of the number written on the envelope and it will be determined that the patient should be placed in the test or control group.
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 Committees of Baqiyatallah Hospital
Street address
mollasadra st, vanak sq sheykh bahayi st,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2024-05-30, 1403/03/10
Ethics committee reference number
IR.BMSU.BAQ.REC.1403.025

Health conditions studied

1

Description of health condition studied
cardiac surgery
ICD-10 code
Z95
ICD-10 code description
Presence of cardiac and vascular implants and grafts

Primary outcomes

1

Description
Conscious desire to drink water
Timepoint
Assessment of thirst immediately after removing the endotracheal tube, one hour later and six hours later on the first day and on the second and third day in the morning, evening and night.
Method of measurement
Numeric Rating Scale

2

Description
Nausea is an uncomfortable feeling in the stomach
Timepoint
Assessment of thirst immediately after removing the endotracheal tube, one hour later and six hours later on the first day and on the second and third day in the morning, evening and night.
Method of measurement
Numeric Rating Scale

3

Description
feeling comfort- thirsty distress
Timepoint
After surgery
Method of measurement
TDS-HF, Score 8-40 Thirsty Distress Scale

4

Description
vomiting severe emptying of stomach contents
Timepoint
Assessment of thirst immediately after removing the endotracheal tube, one hour later and six hours later on the first day and on the second and third day in the morning, evening and night.
Method of measurement
Numeric Rating Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Effective interventions on nausea, vomiting and thirst are performed in the stages before and after surgery. The implementation of the care package for the prevention of gastrointestinal complications after heart surgery includes non-pharmacological interventions that have been extracted by reviewing a range of studies and approved by specialists in special care and heart surgery. The measures include observing the fasting period before surgery, consuming 200 cc of clear carbohydrate liquids two hours before induction of anesthesia, using cold water spray and menthol after removing the tracheal tube for a period of thirty, sixty and ninety minutes.
Category
Prevention

2

Description
Control group: Routine care of the ward including fasting process, controlling nausea and vomiting after surgery, starting oral feeding after surgery will be done.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Jamaran hospital
Full name of responsible person
Seyed Tayeb Moradian
Street address
Tajrish, Bahoner St., Jamaran St., Jamaran Heart Hospital
City
Tehran
Province
Tehran
Postal code
1977916773
Phone
+98 21 2303 4888
Email
t.moradyan@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatullah University of Medical Sciences Vice President of Research
Full name of responsible person
Abbas Ali Imani Fooladi
Street address
mollasadra st, vanak sq sheykh bahayi st,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
t.moradyan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatullah University of Medical Sciences Vice President of Research
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
Seyed Tayeb Moradian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
mollasadra st, vanak sq sheykh bahayi st,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
t.moradyan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Mohammadjavad Shahabi
Position
Masters student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
mollasadra st, vanak sq sheykh bahayi st,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
shahabseyedjavad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Mohammadjavad Shahabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Baqiyatallah University, mollasadra st, vanak sq sheykh bahayi st
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Fax
Email
shahabseyedjavad@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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Readers of articles resulting from this research project will only have access to part of the data, including information related to the main primary outcomes, as well as demographic information in an anonymous form to ensure statistical analysis, and will not allow access to any confidential information of the participants. Personal will not be given.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
The data obtained from the study will be available to all researchers in the field of medical sciences in compliance with the ethical protocols of data release.
Under which criteria data/document could be used
It will be allowed to use the data obtained from the study to carry out related research projects as well as practical use in academic and hospital centers.
From where data/document is obtainable
To receive the data after completing the research project and publishing the resulting thesis, you can refer to the thesis bank of the Central Library of Baghiyallah University of Medical Sciences.
What processes are involved for a request to access data/document
Researchers should first provide the necessary reasons and guarantee to cite the articles resulting from the thesis and then they would be able to send an email to the corresponding author of the project (Mr. seyed mohammadjavad shahabi) with an email address of "shahabseyedjavad@gmail.com" and use the available data to conduct their studies in accordance with the ethical protocol.
Comments
Loading...