Investigating the effect of olive oil consumption on surgical outcomes in open heart surgery patients
Design
.The patients were divided into two groups, 1: control, 2: test. Block random sampling is done on 110 samples, and the obtained information is analyzed using spss software.
Settings and conduct
Patients undergoing open heart surgery in Mehrgan Qazvin Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria
• Non-emergency heart surgery
• No history of significant digestive problems
Exit criteria
Unpredictable events (hemodynamic disturbances, long-term mechanical ventilation, etc.)
Intervention groups
Patients were included in the study as a sample since they were admitted to the hospital for open heart surgery. From the night of hospitalization, according to the type of diet (129), the studied parameters and the patient's conditions, 30 cc of extra virgin olive oil from Rudbar in northern Iran was added to the patient's diet at lunch and dinner (15 cc each meal) on a daily basis. 129-131). This work was done for a month since he was admitted to the hospital for surgery. Patients in the control group were requested to refrain from consuming olive oil, and to inform their respective physicians in case of consumption, in order to withdraw from the study.
Main outcome variables
1. Determining the effect of olive oil consumption on the incidence of pleural effusion in patients after open heart surgery
2. Determining the effect of olive oil consumption on constipation in patients after open heart surgery
3. Determining the effect of olive oil consumed by patients on readmission of patients after open heart surgery after consuming olive oil
4. Determining the effect of olive oil on reducing the pain of open heart surgery in ICU OH patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221005056090N1
Registration date:2022-11-22, 1401/09/01
Registration timing:registered_while_recruiting
Last update:2022-11-22, 1401/09/01
Update count:0
Registration date
2022-11-22, 1401/09/01
Registrant information
Name
golamreza bahrami hidaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3336 5174
Email address
bahramireza67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-19, 1401/08/28
Expected recruitment end date
2022-12-19, 1401/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of olive oil consumption on surgical outcomes in open heart surgery patients
Public title
Investigating the effect of olive oil consumption on surgical outcomes in open heart surgery patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Non-emergency heart surgery
No history of significant digestive problems
Exclusion criteria:
Patients with surgery other than cabg
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method was a block random sampling method. Equal numbers were placed in two groups of test and control. First, 4 blocks were formed by choosing the letter A for the intervention group and choosing the letter B for the control group, such as (-ABBA-ABAB-BABA-BAAB-BBAA- AABB), and a total of six blocks were written on six separate sheets of paper. And it was placed in a container. Then one of the blocks was randomly selected and the first four were selected. This block was again included in the set of blocks and another block was randomly selected for the second time, and in the same way, all the participants were selected according to their entry into the study. People in the test group will be placed in the test group based on having the conditions to enter the study and their satisfaction and ability
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, in order to prevent the analyst from applying the taste of the participating groups to two groups A and B without mentioning the intervention and the witness, the data was entered into the spss software and the analyst was not aware of the allocation of people to the groups in all stages of the study.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatullah University of Medical Sciences
Street address
No. 8, Padgan Street, ally Entezari
City
قزوین
Province
Qazvin
Postal code
4573135747
Approval date
2022-05-25, 1401/03/04
Ethics committee reference number
IR.BMSU.BAQ.REC.1401.014
Health conditions studied
1
Description of health condition studied
Coronary artery surgery
ICD-10 code
I25.7
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris
Primary outcomes
1
Description
Determining the effect of olive oil consumption on the incidence of pleural effusion in patients after open heart surgery
Timepoint
The first day before surgery،The day after the operation،The second week after the operation
Method of measurement
chest x-ray
2
Description
Determining the effect of olive oil consumption on constipation in patients after open heart surgery
Timepoint
The day before the operation،Length of hospitalization،After discharge, twice a week until one month from the time of hospitalization
Method of measurement
Bristol scale
3
Description
Determining the effect of olive oil consumed by patients on readmission of patients after open heart surgery after consuming olive oil
Timepoint
One month from the time of hospitalization in case of patient referral
Method of measurement
Hospital admission
4
Description
Determining the effect of olive oil on reducing the pain of open heart surgery in ICU OH patients
Timepoint
The day before the operation،Length of hospitalization،After discharge, twice a week until one month from the time of hospitalization
Method of measurement
vas scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who were admitted to the hospital for open heart surgery were candidates to enter the study as a sample. From the night of hospitalization, according to the type of diet, the investigated parameters and the patient's conditions, the amount of 30 cc of extra virgin olive oil from Rudbar North of Iran will be added to the patient's diet at lunch and dinner (15 cc each meal) on a daily basis. Hospitalization for surgery is done for one month
Category
Diagnosis
2
Description
Control group: patients do not receive any amount of olive oil
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehrgan Qazvin Superspeciality Hospital
Full name of responsible person
Seyed Saeed Farzam
Street address
Northern Ferdowsi Street, next to the Dialysis Center of Mehrgan Hospital
City
قزوین
Province
Qazvin
Postal code
4573135747
Phone
+98 28 3336 5161
Email
bahramireza67@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Abbas Ebadi
Street address
Sheikh Bahai Street, Baqiyatullah University, Faculty of Nursing
City
tehran
Province
Tehran
Postal code
4573135747
Phone
+98 21 8755 0001
Email
ebadi1347@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
60
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
Dr. Abbas Ebadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sheikh Bahai Street, Baqiyatullah University, Faculty of Nursing
City
trhran
Province
Tehran
Postal code
4573135747
Phone
+98 21 8755 0001
Email
ebadi1347@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Maleeha Sadat Moid
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sheikh Bahai Street, Baqiyatullah University, Faculty of Nursing
City
tehran
Province
Tehran
Postal code
4573135747
Phone
+98 21 8755 0001
Email
msmoayed@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yasser Saeed
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sheikh Bahai Street, Baqiyatullah University, Faculty of Nursing
City
Tehran
Province
Tehran
Postal code
3574745737
Phone
+98 21 8755 0001
Email
yasernurse84@yahoo.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