Development of a Mobile Application and Determination of Its Effects

November 5, 2024 updated by: Berrin Pazar, Lokman Hekim Üniversitesi

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • Gülhane Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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,
  • not having hearing or vision problems,
  • having the ability to use the mobile application.

Exclusion Criteria:

  • having emergency surgery,
  • having previously been treated in the ICU,
  • wanting to leave the study at any stage of the project.

Inclusion Criteria:

for nurses;

  • working in the cardiovascular surgery ICU,
  • being a volunteer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mobile application training group
The group that will be trained by downloading the mobile application to their mobile phones
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
As soon as you are admitted to the clinic and on the first day after the surgery
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
Immediately after admission to the clinic, after waking up in the intensive care unit and on the first day after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comfort of patients
Time Frame: 1st day after surgery
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.
1st day after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
satisfaction with mobile application
Time Frame: after using the app (1st day after surgery)
no scale will be used. Participants will be asked to evaluate the mobile application.
after using the app (1st day after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Meltem Meriç, assoc prof, Lokman Hekim Üniversitesi
  • Study Director: Kaan Kaya, assoc prof, Ankara Etlik City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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