Cardiovascular SurgeryNCT06677476
Development of a Mobile Application and Determination of Its Effects
A study testing mobile application training in people with Cardiovascular Surgery and Mobile Application, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
It has been determined that patients who have undergone heart surgery have a lack of knowledge about preoperative preparation and postoperative intensive care unit. In order to eliminate the lack of knowledge, patient education has gained importance in the preoperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Surgery, Mobile Application, Patient Education
- What is being tested?
- mobile application training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- for patients;
- having elective open heart surgery,
- being a volunteer,
- being 18 years of age or older,
- knowing Turkish,
- not having a mental disability that may prevent communication,
Show all 11Show fewer
- not having hearing or vision problems,
- having the ability to use the mobile application.
- for nurses;
- working in the cardiovascular surgery ICU,
- being a volunteer
Who cannot join
- having emergency surgery,
- having previously been treated in the ICU,
- wanting to leave the study at any stage of the project.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Determining the Effect of Mobile Application for Patients Who Will Have Cardiac Surgery and Cardiovascular Surgery Intensive Care Unit Nurses
It has been determined that patients who have undergone heart surgery have a lack of knowledge about preoperative preparation and postoperative intensive care unit. In order to eliminate the lack of knowledge, patient education has gained importance in the preoperative period. At the same time, it is stated that nurses working in cardiovascular surgery intensive care units need continuous education to cope with the difficulties related to the increasing complexity of patient conditions and technology. With the advancement of technology, mobile applications have become an integral part of the continuous education of patients and nurses. This project was planned to evaluate the effect of the mobile application to be developed for patients who will undergo heart surgery on patient outcomes and the effect of the mobile application to be developed for nurses who provide patient care in intensive care units on the self-efficacy of nurses. In the first step of the project, the content of the mobile application will be developed, expert opinions will be obtained and the comprehensibility of patients and nurses will be tested. The software of the mobile application will be completed by shooting the necessary videos for the final content. In the second step of the project, the effect of the developed mobile application on anxiety, comfort and intensive care unit experiences in patients who meet the inclusion criteria will be examined. A randomized controlled experimental design will be used in this stage. State-Trait Anxiety Inventory, Early Postoperative Comfort Scale (EPQI), Intensive Care Experiences Scale will be used to collect data. Self-Efficacy Scale will be applied to nurses without randomization before and after using the mobile application. Data obtained in the study will be evaluated in a computer environment using SPSS data package program. In statistical decisions, p<0.05 level will be accepted as a significant difference indicator.
Read the detailed description
Population and sample of the project:
The population will consist of all patients undergoing surgery in the Department of Cardiovascular Surgery at Lokman Hekim University Akay Hospital and treated in the ICU. Power analysis was performed to determine the number of people to be included in the study. The power of the test was calculated with the G*Power 3.1 programme. As a similar study in the relevant literature, Pehlivan (2021) calculated the effect size for the state anxiety difference as 0.646. In order to exceed the 90% value in determining the power of the study; 84 people, including 42 people in groups with a significance level of 5% and an effect size of 0.646, should be reached (df=82; t=1.664). Considering the high power of the test and the losses in the study, it was aimed to reach a total of 100 people, including 50 people in the groups.
All nurses working in the ICU of the Cardiovascular Surgery Department of Lokman Hekim University Akay Hospital will constitute the population of the study (N:10) and the nurses who volunteered to participate in the study will constitute the sample. Without randomisation for nurses, all nurses will be ensured to use the mobile application, pre-test and post-test will be performed.
Translated with DeepL.com (free version)
- Being tested
- mobile application training
- Keywords
- Intensive care nursing, Surgery Nursing, Nursing Care, Heart surgery, Mobile application development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile application trainingOther
Researchers compiled literature information and used their expertise to create mobile application content. This content will be downloaded to mobile phones via mobile application software and participants will be trained.
| Study group | Role | What they receive |
|---|---|---|
| mobile application training group | Experimental | The group that will be trained by downloading the mobile application to their mobile phones Receives: Other: mobile application training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' anxiety
The State and Trait Anxiety scale can be scored between a minimum of 20 and a maximum of 80. As the score increases, the level of anxiety increases.
Measured: As soon as you are admitted to the clinic and on the first day after the surgery
blood pressure
Blood pressure will be measured manually
Measured: Immediately after admission to the clinic, after waking up in the intensive care unit and on the first day after surgery
Secondary outcomes (1)
comfort of patients
Early Postoperative Comfort Scale; The highest total score is 144 and the lowest total score is 24. A low score indicates poor comfort and a high score indicates good comfort.
Measured: 1st day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start15 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular SurgeryStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Training will be given on the mobile application to be downloaded to the mobile phone.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Berrin Pazar, Lokman Hekim University
- Investigators
- Meltem Meriç, assoc prof, Study chair, Lokman Hekim UniversityKaan Kaya, assoc prof, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677476
- Sponsor's protocol ID
- 2023103
- Status last verified
- Nov 2024
- First submitted
- 25 Oct 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Determining the Effect of Mobile Application for Patients Who Will Have Cardiac Surgery and Cardiovascular Surgery Intensive Care Unit Nurses
- ClinicalTrials.gov ID
- NCT06677476
- Acronym / sponsor ID
- 2023103
- Keywords
- Intensive care nursing, Surgery Nursing, Nursing Care, Heart surgery, Mobile application development
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Nov 2024 (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.
It has been determined that patients who have undergone heart surgery have a lack of knowledge about preoperative preparation and postoperative intensive care unit. In order to eliminate the lack of knowledge, patient education has gained importance in the preoperative period. At the same time, it is stated that nurses working in cardiovascular surgery intensive care units need continuous education to cope with the difficulties related to the increasing complexity of patient conditions and technology. With the advancement of technology, mobile applications have become an integral part of the continuous education of patients and nurses. This project was planned to evaluate the effect of the mobile application to be developed for patients who will undergo heart surgery on patient outcomes and the effect of the mobile application to be developed for nurses who provide patient care in intensive care units on the self-efficacy of nurses. In the first step of the project, the content of the mobile application will be developed, expert opinions will be obtained and the comprehensibility of patients and nurses will be tested. The software of the mobile application will be completed by shooting the necessary videos for the final content. In the second step of the project, the effect of the developed mobile application on anxiety, comfort and intensive care unit experiences in patients who meet the inclusion criteria will be examined. A randomized controlled experimental design will be used in this stage. State-Trait Anxiety Inventory, Early Postoperative Comfort Scale (EPQI), Intensive Care Experiences Scale will be used to collect data. Self-Efficacy Scale will be applied to nurses without randomization before and after using the mobile application. Data obtained in the study will be evaluated in a computer environment using SPSS data package program. In statistical decisions, p<0.05 level will be accepted as a significant difference indicator.
Detailed description
Population and sample of the project:
The population will consist of all patients undergoing surgery in the Department of Cardiovascular Surgery at Lokman Hekim University Akay Hospital and treated in the ICU. Power analysis was performed to determine the number of people to be included in the study. The power of the test was calculated with the G*Power 3.1 programme. As a similar study in the relevant literature, Pehlivan (2021) calculated the effect size for the state anxiety difference as 0.646. In order to exceed the 90% value in determining the power of the study; 84 people, including 42 people in groups with a significance level of 5% and an effect size of 0.646, should be reached (df=82; t=1.664). Considering the high power of the test and the losses in the study, it was aimed to reach a total of 100 people, including 50 people in the groups.
All nurses working in the ICU of the Cardiovascular Surgery Department of Lokman Hekim University Akay Hospital will constitute the population of the study (N:10) and the nurses who volunteered to participate in the study will constitute the sample. Without randomisation for nurses, all nurses will be ensured to use the mobile application, pre-test and post-test will be performed.
Translated with DeepL.com (free version)
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Training will be given on the mobile application to be downloaded to the mobile phone.
| Arm | Type | Receives |
|---|---|---|
| mobile application training group | Experimental | Other: mobile application trainingThe group that will be trained by downloading the mobile application to their mobile phones |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- for patients;
- having elective open heart surgery,
- being a volunteer,
- being 18 years of age or older,
- knowing Turkish,
Key exclusion criteria (3 listed)
- having emergency surgery,
- having previously been treated in the ICU,
- wanting to leave the study at any stage of the project.
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 |
|---|---|---|
| mobile application trainingResearchers compiled literature information and used their expertise to create mobile application content. This content will be downloaded to mobile phones via mobile application software and participants will be trained. | Other | mobile application training group |
Primary outcome
Patients' anxiety
Time frame: As soon as you are admitted to the clinic and on the first day after the surgery
The State and Trait Anxiety scale can be scored between a minimum of 20 and a maximum of 80. As the score increases, the level of anxiety increases.
blood pressure
Time frame: Immediately after admission to the clinic, after waking up in the intensive care unit and on the first day after surgery
Blood pressure will be measured manually
1 secondary outcome
comfort of patients
Time frame: 1st day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Meltem Meriç, assoc prof study chair
Lokman Hekim University
Kaan Kaya, assoc prof study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile application training in people with Cardiovascular Surgery and Mobile Application, run by Lokman Hekim University 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 11 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patients' anxiety (time frame: As soon as you are admitted to the clinic and on the first day after the surgery). 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?
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 6 Nov 2024.