Investigating the effect of smartphone-based monitoring and follow-up program implementation on the quality of life and pain of patients undergoing coronary artery bypass graft surgery
Determining the impact of implementing a smartphone-based monitoring and follow-up program on the quality of life and pain of patients after coronary artery bypass graft surgery (CABG).
Design
Parallel randomized controlled, on 80 patients
Settings and conduct
Shahid Ayatollah Beheshti Hospital, Shiraz, procedures: first stage: before surgery, second stage: from the time after transfer to the ward until discharge and third stage: after discharge until one month later
Participants/Inclusion and exclusion criteria
Inclusion criteria
Willingness to participate in the study
Having awareness and mental health
Coronary artery bypass graft surgery for the first time
Non-urgent coronary artery bypass graft surgery
Not having a history of mental disorder
The patient himself or his active companion should be literate
The patient himself or his active companion should have a smartphone and the possibility of using the internet for the patient or his companion within 30 days after the leave
Drug addiction such as opium
Intervention groups
The samples are randomly assigned to intervention and control groups. The implementation of the intervention in the intervention group is carried out in three stages. first stage; Before the operation, the second stage; After discharge from the intensive care unit until hospital discharge and the third stage; After discharge up to 30 days. Actions such as providing an educational package regarding surgical care with an emphasis on pain reduction through messenger and monitoring and follow-up of the patient by telephone are carried out in these three stages. In the control group, educational content in the form of pamphlets and photos will be provided to them regarding surgical care with an emphasis on pain reduction.
Main outcome variables
Pain and Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240426061574N1
Registration date:2024-06-05, 1403/03/16
Registration timing:registered_while_recruiting
Last update:2024-06-05, 1403/03/16
Update count:0
Registration date
2024-06-05, 1403/03/16
Registrant information
Name
Mohammadamin Mahmoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3650 6298
Email address
ma.mahmoodi@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-04, 1403/03/15
Expected recruitment end date
2025-03-05, 1403/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of smartphone-based monitoring and follow-up program implementation on the quality of life and pain of patients undergoing coronary artery bypass graft surgery
Public title
The effect of smartphone-based monitoring and follow-up program on the quality of life and pain of patients undergoing coronary artery bypass graft surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Having awareness and mental health
Coronary artery transplant surgery for the first time
Non-emergent coronary artery bypass graft surgery
Not having a history of mental disorder
The patient herself or her active companion should be literate
The patient herself or her active companion should have a smartphone and the possibility of using the internet for the patient or her companion within 30 days after the leave.
Exclusion criteria:
Addiction to drugs such as opium, which makes it difficult to feel pain and control it.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The list prepared in the number of 80 envelopes, the sequence of the groups written in the list is specified and the envelopes will remain closed. According to the study diagram, the envelopes will be opened and the people will be randomly placed in the intervention 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
Research Ethics Committees of Shahid Sadoughi University of Medical Sciences
Street address
Imam Hossein Square, Imam Reza Complex, Research and Technology Deputy, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8916877443
Approval date
2024-03-06, 1402/12/16
Ethics committee reference number
IR.SSU.REC.1402.145
Health conditions studied
1
Description of health condition studied
Undergoing coronary artery bypass surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life
Timepoint
Pre-test stage: before surgery and during admission; Post-test stage: 30 days after discharge from the hospital
Method of measurement
The 36-Item Short Form Survey (SF-36) to measure Quality of Life
2
Description
Pain
Timepoint
Basic pain control in the preoperative phase; In the stage after discharge from the intensive care unit until discharge from the hospital, pain control three times a day in person; In the phase after discharge up to 30 days later, pain control in the form of phone calls on days 7, 14, 21 and 30.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Actions for the intervention group during the three stages of the research: -Primary level; Developing a multimedia educational package for coronary artery bypass surgery: A multimedia educational package will be developed before the study begins. The educational package will be developed and presented in two parts. Each of these two parts has several episodes in the form of movies and animations and several episodes in text and photos. The files will be prepared for display on smartphones with Android or IOS operating systems: *Pre-operative part: Information such as general explanations of heart surgery, providing education about drains, surgical incision sites, expectations from hospitalization in the pre-operative, post-operative phases and transfer to the intensive care unit, after transfer from Special care department to department until hospitalization, change of dressings and other care until discharge. We will use videos and images that do not have many details and unpleasant images and only introduce the patient and his companion to the general principles of CABG and important care. ** The post-operative part: Information like important care at home after CABG, prescription drugs and administration, pain reduction methods (common pharmaceutical and non-pharmacological methods), and practical solutions to reduce stress. --The first stage (before surgery): during the pre-surgery stage, during an in-person meeting, after explaining the study process and completing the informed consent, the pre-surgery training package is sent to the patient and his companion through a messenger. The researcher expresses some selections from the contents of the educational package in order to better understand the purpose of the package for the patient and the family. In the same session, the internet package service is activated for the patient. Also, the patient's pain score and basic vital signs will be checked and charted. The quality of life questionnaire will be completed as a pre-test. --The second stage (from the time after transfer to the ward until discharge): This stage starts when the patient's tracheal tube is removed in the intensive care unit so that the patient has the opportunity to express and pretend to be in pain. At first, the pain monitoring using the visual pain scale (VAS) and the vital signs (blood pressure and heart rate) are simultaneously checked by the researcher using the monitoring device and recorded in the chart that has been prepared in advance. The pain score and vital signs will be assessed and documented every eight hours. Also, in case of changes from the normal level and drug intervention to reduce pain or control blood pressure, the type of drug, dose, and its repetition are recorded. In the last days close to discharge, the researcher in the presence of the patient and with the cooperation of the patient will review the implementation of the training course after discharge. After the operation, the educational package is sent to the patient and his companion through messenger. Additional explanations will be provided regarding the multimedia educational package after the operation and the content it covers. Before discharge, all prescribed medications (before and after surgery) are recorded in the patient's chart. --The third stage (after discharge to one month later (30 days after discharge)): One month period after discharge, including monitoring and recording the pain score and vital signs, including blood pressure and pulse on days 7 and 14. , 21 and 30. He is asked to state his blood pressure, pulse rate, and pain score by making phone calls to each person on specified days. During calls, the patient is asked. The time of making the call will be from 9:00 am to 1:00 pm in order not to disturb the patient (if the patient wishes, this time will be postponed). During the calls, the educational needs of the patient regarding care will be examined with an emphasis on pain reduction and the necessary explanations will be provided. The quality of life questionnaire will be completed as a post-test on the 30th day.
Category
N/A
2
Description
Control group: Actions for the control group during the three phases of the research: **preliminary phase; Compilation of an educational booklet focusing on the main topics related to CABG procedure, care, and how to monitor pain in patients and presenting the booklet to patients and their families. "The evaluation and monitoring of patients in the control group in terms of timing and follow-up will be similar to the intervention group." In this way; --The first stage (before surgery): during an in-person meeting, after explaining the study process and completing the informed consent, an educational booklet is presented to the patient and his family. The patient's pain score and basic vital signs will be checked and charted. The quality of life questionnaire will be completed as a pre-test. The second stage (from the time after transfer to the ward to discharge): This stage starts from the time the patient's tracheal tube is removed in the special care department until the patient can express and pretend to have pain At first, the pain monitoring using the visual pain scale (VAS) and the vital signs (blood pressure and heart rate) are checked simultaneously by the researcher using the monitoring device and are recorded in the chart that has been prepared in advance. Check and register the pain score and vital signs every eight hours. Also, in case of changes from the normal level and drug intervention to reduce pain or control blood pressure, the type of drug, dose, and its repetition are recorded. In the last days close to the discharge, the researcher, in the presence of the patient and with the patient's cooperation, explains how to implement the post-operative follow-up and the calls that are made to check the pain and vital signs and complete the quality of life questionnaire. Before discharge, all prescribed medications (before and after surgery) are recorded in the patient's chart. The third stage (after discharge to one month later (30 days after discharge)): One month period after discharge, including monitoring and recording the pain score and vital signs including blood pressure and pulse (using a sphygmomanometer) on 7 days. 14, 21 and 30. By making a phone call to each person on the specified days, he is asked to state his blood pressure, pulse rate, and pain score. The call time will be from 9:00 am to 1:00 pm in order not to disturb (if the patient wishes, this time will be postponed). The quality of life questionnaire will be completed as a post-test on the 30th day.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Abbas Mohseni
Street address
Shiraz, Vali Asr Square, Shahid Beheshti Hospital
City
Shiraz
Province
Fars
Postal code
7136816695
Phone
+98 71 3224 1161
Email
beheshti_shiraz.hos@tamin.ir
Web page address
https://www.tamin.ir/news/43359.html
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargouei
Street address
Imam Hossein square, (the beginning of the) Student Blvd, Imam Reza research educational complex, Vice president for research and technology of Shahid Sadougi University of Medical Sciences, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۸۸۶۳۷
Phone
+98 35 3733 3726
Email
abargouei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Bakhshi
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery faculty, in front of Infertility center, Boali St, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 1751 3824
Email
fateme.bakhshii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Bakhshi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery faculty, in front of Infertility center, Boali St, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
fateme.bakhshii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Bakhshi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Service Management
Street address
Nursing and Midwifery faculty, in front of Infertility center, Boali St, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3628 7900
Fax
Email
fateme.bakhshii@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
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All personal data of study participants can be shared after de-identification. Data sharing is done in the form of uploading in official data sharing databases or following the request of the applicant in the form of an email to the responsible author's email.
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
The data will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
For scientific application and use for systematic review studies
From where data/document is obtainable
Fateme Bakhshi, Yazd, Bu Ali St., Safaiyeh, Nursing and Midwifery Faculty, Shahid SadouqiUniversity of Medical Sciences, Postal code: 8916877443 Phone: 0098 9139684626 Email address: Fateme.bakhshii@gmail.com; f.bakhshi@ssu. ac.ir
What processes are involved for a request to access data/document