Open Heart Surgery PatientsNCT05094063
Patient Education by Mobile Application
A study testing patient education by mobile application in people with Open Heart Surgery Patients, run by Betul Zeynep Yildiz at 1 site in Turkey (Türkiye).
Trial summary
Cardiovascular diseases are among the important health problems that cause mortality and morbidity both in our country and in the World (Sidar vd 2013). According to the data of the Turkish Statistical Institute (2021), circulatory system diseases were the first cause of mortality in our country in 2018 with a rate of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Open Heart Surgery Patients
- What is being tested?
- patient education by mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- voluntarily accepting to participate in the study
- 18 years and over
- Having planned surgery
- Conscious Open
- Coming to the clinic from the intensive care unit after the operation
- Having no vision, hearing and speech problems
Show all 10Show fewer
- Stable clinical condition
- Able to communicate
- Having a phone with Android operating system (for the experimental group)
- Patients without a psychiatric history
Who cannot join
- Cancellation of the operation
- Inability to communicate with the patient
- The patient's desire to withdraw from the study
- Deterioration of the patient's clinical condition
- The patient's inability to use the mobile application
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Supported by the Mobile Application Given to Patients Undergoing Open Heart Surgery on Postoperative Recovery and Psychological Well-Being of Patients
Cardiovascular diseases are among the important health problems that cause mortality and morbidity both in our country and in the World (Sidar vd 2013). According to the data of the Turkish Statistical Institute (2021), circulatory system diseases were the first cause of mortality in our country in 2018 with a rate of 38.4%. According to the data of the World Health Organization, the disease that causes the most death in the world is ischemic heart disease with 16% (World Health Organization,2021).
In addition to acute care, the aim of education in patients with cardiovascular surgery is to support patients' self-care and post-operative recovery, to enable patients and their families to self-manage their care at home, to reduce postoperative complications and rehospitalization rates(Akyolcu vd 2017).
Read more
Training can be delivered using a combination of formats including brochures, online, books, audio cassette, videotape, and/or skype (Fredericks \& Yau, 2012). Booklets, brochures, tele-health, and web design methods were used in the training given to patients who had heart surgeries in previous years in our country.
In this study, the training booklet to be used in the education to be given to the patients will be prepared by the researchers. The content of the prepared training booklet will be presented to patients in the form of a mobile application that can run on smart phones with Android operating system so that patients can follow it. With this research, it is aimed to facilitate access to information and accelerate post-operative recovery. In the future, this practice will also contribute to reducing stationery costs.
Read the detailed description
In this study, the training booklet to be used in the education to be given to the participants will be prepared by the researchers. In addition, the content of the prepared training booklet will be presented to participants in the form of a mobile application that can run on smart phones with Android operating system so that participants can follow it. In the content of the mobile application, there will be an interface with the information in the booklet and the video narration of the exercises that the participants should do. This application will be downloadable through the server and then there will be no internet requirement to use the application. The mobile application will be installed on the participants' own phones. The participants will be able to adjust the font size in the application. The participants will see the titles in the booklet and will reach the information by choosing the subject curious about. Participants will also be able to listen to the information in the booklet in the form of an audio recording. In addition, reminder notifications for medications and exercises will be set for participants in the mobile application. In this way, it will be easier for participants to access information, and it will be ensured that participants do not forget participants medication hours and that they do the exercises participants need to do during the day without forgetting. Every day between 18.30-20.30, a questionnaire will be sent to the user to evaluate the amount/time of exercise participants has applied for that day. Thus, it will be ensured that the answers of the participants are sent to the server and the daily follow-up of the participants will be carried out. The device will need internet access to send information. The information sent will be kept on the database and can be easily processed. However, it will be possible to easily access the user's historical information without data confusion. It is planned to store the data on MySql (My Structured Query Language) database. If any update is required to the application, it will be carried out quickly through the server. After the research, the use of the mobile application will be continued and sustainability will be ensured in the postoperative recovery and psychological well-being of the participants.
- Conditions
- Open Heart Surgery Patients
- Being tested
- patient education by mobile application
- Keywords
- open heart surgery, surgical nursing, patient education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient education by mobile applicationOther
Training will be given to the patients in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Training will be given to the patients in the experimental group. Receives: Other: patient education by mobile application |
| control group | No intervention | untrained patient group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Postoperative Recovery Index (PoRI) at month 3
There are 5 sub-dimensions of PoRI; psychological symptoms, physical activities, general symptoms, intestinal symptoms, and craving-desire symptoms. The scores of the items included in the sub-dimensions are summed, their arithmetic average is taken, and the sub-dimension score is determined. A minimum of 1 and a maximum of 5 points can be obtained from the PoRI. High scores from the index reflect more difficulty in post-operative recovery, while low scores indicate that post-operative recovery is easier.
Measured: Baseline and month 3
Change from baseline in Psychological Well-Being at month 3
Flourishing Scale (FS), which is a psychological well-being scale in Turkish identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life. The items of FS are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). A minimum of 8 and a maximum of 56 points can be obtained from the FS. A high score indicates that the person has many psychological resources and strengths.
Measured: Baseline and month 3
Secondary outcomes (1)
Change from baseline in StateTrait Anxiety Inventory at month 3
The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings, and the 20-item 'trait anxiety scale', which was created to determine the feelings in general. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety).
Measured: Baseline and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Sep 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Open Heart Surgery PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This research was planned as an experimental randomized controlled trial. Randomization will be done using a computer program. With the computer program (www.randomizer.org), the participants will be divided into 2 subgroups (group 1: patient education group; group 2: patient education group not provided). With the randomization program, the order of the experimental and control groups will be provided.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betul Zeynep Yildiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Betul Zeynep Yildiz, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094063
- Sponsor's protocol ID
- 2021/03-41
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fredericks S, Yau TM. Educational interventions for adults to prevent readmission and complications following cardiovascular surgery. Cochrane Database of Systematic Reviews 2012, Issue 9.
Sidar A , Dedeli Ö, İşkesen Aİ. The Relationship Between Anxiety, Pain Distress and Pain Severity Before and After Open Heart Surgery in Patients Yoğun Bakım Derg, 2013, 4: 1-8.
Akyolcu N, Kanan N, Güler A. Cerrahi Hemşireliği II, 1. Baskı. İstanbul, Nobel Tıp Kitapevleri, 2017: 101-114.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Supported by the Mobile Application Given to Patients Undergoing Open Heart Surgery on Postoperative Recovery and Psychological Well-Being of Patients
- ClinicalTrials.gov ID
- NCT05094063
- Acronym / sponsor ID
- 2021/03-41
- Conditions
- Open Heart Surgery Patients
- Keywords
- open heart surgery, surgical nursing, patient education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Betul Zeynep YildizUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular diseases are among the important health problems that cause mortality and morbidity both in our country and in the World (Sidar vd 2013). According to the data of the Turkish Statistical Institute (2021), circulatory system diseases were the first cause of mortality in our country in 2018 with a rate of 38.4%. According to the data of the World Health Organization, the disease that causes the most death in the world is ischemic heart disease with 16% (World Health Organization,2021).
In addition to acute care, the aim of education in patients with cardiovascular surgery is to support patients' self-care and post-operative recovery, to enable patients and their families to self-manage their care at home, to reduce postoperative complications and rehospitalization rates(Akyolcu vd 2017).
Training can be delivered using a combination of formats including brochures, online, books, audio cassette, videotape, and/or skype (Fredericks \& Yau, 2012). Booklets, brochures, tele-health, and web design methods were used in the training given to patients who had heart surgeries in previous years in our country.
In this study, the training booklet to be used in the education to be given to the patients will be prepared by the researchers. The content of the prepared training booklet will be presented to patients in the form of a mobile application that can run on smart phones with Android operating system so that patients can follow it. With this research, it is aimed to facilitate access to information and accelerate post-operative recovery. In the future, this practice will also contribute to reducing stationery costs.
Detailed description
In this study, the training booklet to be used in the education to be given to the participants will be prepared by the researchers. In addition, the content of the prepared training booklet will be presented to participants in the form of a mobile application that can run on smart phones with Android operating system so that participants can follow it. In the content of the mobile application, there will be an interface with the information in the booklet and the video narration of the exercises that the participants should do. This application will be downloadable through the server and then there will be no internet requirement to use the application. The mobile application will be installed on the participants' own phones. The participants will be able to adjust the font size in the application. The participants will see the titles in the booklet and will reach the information by choosing the subject curious about. Participants will also be able to listen to the information in the booklet in the form of an audio recording. In addition, reminder notifications for medications and exercises will be set for participants in the mobile application. In this way, it will be easier for participants to access information, and it will be ensured that participants do not forget participants medication hours and that they do the exercises participants need to do during the day without forgetting. Every day between 18.30-20.30, a questionnaire will be sent to the user to evaluate the amount/time of exercise participants has applied for that day. Thus, it will be ensured that the answers of the participants are sent to the server and the daily follow-up of the participants will be carried out. The device will need internet access to send information. The information sent will be kept on the database and can be easily processed. However, it will be possible to easily access the user's historical information without data confusion. It is planned to store the data on MySql (My Structured Query Language) database. If any update is required to the application, it will be carried out quickly through the server. After the research, the use of the mobile application will be continued and sustainability will be ensured in the postoperative recovery and psychological well-being of the participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research was planned as an experimental randomized controlled trial. Randomization will be done using a computer program. With the computer program (www.randomizer.org), the participants will be divided into 2 subgroups (group 1: patient education group; group 2: patient education group not provided). With the randomization program, the order of the experimental and control groups will be provided.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: patient education by mobile applicationTraining will be given to the patients in the experimental group. |
| control group | No intervention | –untrained patient group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- voluntarily accepting to participate in the study
- 18 years and over
- Having planned surgery
- Conscious Open
- Coming to the clinic from the intensive care unit after the operation
Key exclusion criteria (5 listed)
- Cancellation of the operation
- Inability to communicate with the patient
- The patient's desire to withdraw from the study
- Deterioration of the patient's clinical condition
- The patient's inability to use the mobile application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient education by mobile applicationTraining will be given to the patients in the experimental group. | Other | experimental group |
Primary outcome
Change from baseline in Postoperative Recovery Index (PoRI) at month 3
Time frame: Baseline and month 3
There are 5 sub-dimensions of PoRI; psychological symptoms, physical activities, general symptoms, intestinal symptoms, and craving-desire symptoms. The scores of the items included in the sub-dimensions are summed, their arithmetic average is taken, and the sub-dimension score is determined. A minimum of 1 and a maximum of 5 points can be obtained from the PoRI. High scores from the index reflect more difficulty in post-operative recovery, while low scores indicate that post-operative recovery is easier.
Change from baseline in Psychological Well-Being at month 3
Time frame: Baseline and month 3
Flourishing Scale (FS), which is a psychological well-being scale in Turkish identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life. The items of FS are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). A minimum of 8 and a maximum of 56 points can be obtained from the FS. A high score indicates that the person has many psychological resources and strengths.
1 secondary outcome
Change from baseline in StateTrait Anxiety Inventory at month 3
Time frame: Baseline and month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- BackgroundFredericks S, Yau TM. Educational interventions for adults to prevent readmission and complications following cardiovascular surgery. Cochrane Database of Systematic Reviews 2012, Issue 9.
- BackgroundSidar A , Dedeli Ö, İşkesen Aİ. The Relationship Between Anxiety, Pain Distress and Pain Severity Before and After Open Heart Surgery in Patients Yoğun Bakım Derg, 2013, 4: 1-8.
- BackgroundAkyolcu N, Kanan N, Güler A. Cerrahi Hemşireliği II, 1. Baskı. İstanbul, Nobel Tıp Kitapevleri, 2017: 101-114.
- WHO internet web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient education by mobile application in people with Open Heart Surgery Patients, run by Betul Zeynep Yildiz at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Postoperative Recovery Index (PoRI) at month 3 (time frame: Baseline and month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05094063, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.