Determining the effect of nurse-led educational supportive intervention on recovery quality after coronary bypass surgery
Design
This clinical study involves a two-group intervention. 68 patients will be randomly allocated into four groups by site http://www.jerrydallal.com/random/randomize.htm with a lottery determining placement in the intervention or control group until end of the study.
Settings and conduct
The study environment was determined to conduct research in the cardiac surgery department at Shariati Hospital in Tehran. Participants will have weekly virtual group discussions with the researcher, beginning with a one-hour session before surgery. The contact number of the researcher will be provided to the participants to discuss any topic. After discharge, participants will join a virtual group of 8-10 people on an accessible platform to read and discuss the manual weekly.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Being on the elective coronary artery bypass surgery list
2. Experience heart surgery for the first time
3. Ability to read and write in Persian
4. Access and ability to use a smartphone
5. Absence of irreparable visual and hearing disorders
6. 18 to 60 years old
Non-inclusion criteria:
1. Performing coronary artery bypass surgery and valve replacement or other surgeries at the same time
2. Having diagnosed psychological disorders
3. Off pump surgery
Intervention groups
In the intervention group, the researcher will provide explanations based on the patient's needs. Also, the booklet designed by the research team is provided for additional training.
The control group will receive the usual care.
Main outcome variables
Postoperative recovery quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100725004443N31
Registration date:2023-06-16, 1402/03/26
Registration timing:prospective
Last update:2023-06-16, 1402/03/26
Update count:0
Registration date
2023-06-16, 1402/03/26
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Nurse-led Educational Supportive Intervention on Recovery Quality After Coronary Bypass Surgery
Public title
The Effect of Nurse-led Educational Supportive Intervention on Recovery Quality After Coronary Bypass Surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being on the elective coronary artery bypass surgery list
Experience heart surgery for the first time
Ability to read and write in Persian
Access and ability to use a smartphone
Absence of irreparable visual and hearing disorders
18 to 60 years old
Exclusion criteria:
Performing coronary artery bypass surgery and valve replacement or other surgeries at the same time
Having diagnosed psychological disorders
Off pump surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
68 patients who are candidates for CABG surgery will be included in the study based on the inclusion criteria and then, to prevent information leakage, through random allocation through the site "http://www.jerrydallal.com/random/randomize.htm" they will be divided into four groups, which will be placed in the intervention or control group by lottery. With the discharge of the last person from each group, the next group is selected and this process will continue until the end of sampling.
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
Dr. Shariati Hospital's educational, research and treatment center
Street address
North karegar Street, Jalal Al-Ahmad Expressway, Dr. Shariati Hospital.
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2023-05-21, 1402/02/31
Ethics committee reference number
IR.TUMS.SHARIATI.REC.1402.028
Health conditions studied
1
Description of health condition studied
Cardiovascular Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Post Operative Recovery Quality By PQRS Questionnaire
Timepoint
Before the intervention, 24 hours after the operation, then weekly until one month after the operation
Method of measurement
Postoperative Quality of Recovery Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before the surgery, the researcher arranges a one-hour session with the patients present in this group in person and answers their questions about the study and how the work is done, while addressing their concerns. The booklet designed by the research team is made available to individuals. The researcher's contact number is provided to patients for possible problem-solving during the study. The content of the booklet will be discussed and studied weekly on a virtual platform during non-face-to-face sessions, and the researcher will monitor the conditions of the subjects and complete the questionnaire during weekly phone calls.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان دکتر شریعتی
Full name of responsible person
Masoumeh Zakerimoghadam
Street address
North Karegar Street, Jalal Al-Ahmad Expressway, Dr. Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor of Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.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
1
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 Baharestani
Position
Medical-Surgical Nursing Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tawheed Square, Dr. Mirkhani St. (East Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 2286 2160
Fax
Email
f.baharestani06@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zakerimoghadam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ghods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 2286 2160
Fax
+98 21 6659 1888
Email
zakerimo@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Baharestani
Position
Medical-Surgical Nursing Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 2248 0621
Fax
Email
f.baharestani06@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD