- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05094063
Patient Education by Mobile Application
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).
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Erzurum, Turkey
- Ataturk University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Stable clinical condition
- Able to communicate
- Having a phone with Android operating system (for the experimental group)
- Patients without a psychiatric history
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: experimental group
Training will be given to the patients in the experimental group.
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Training will be given to the patients in the experimental group.
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No Intervention: control group
untrained patient group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Postoperative Recovery Index (PoRI) at month 3
Time Frame: Baseline and month 3
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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.
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Baseline and month 3
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Change from baseline in Psychological Well-Being at month 3
Time Frame: Baseline and month 3
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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.
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Baseline and month 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in StateTrait Anxiety Inventory at month 3
Time Frame: Baseline and month 3
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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).
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Baseline and month 3
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021/03-41
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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