Development of a Mobile Application and Determination of Its Effects

NCT ID: NCT06677476

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2026-10-31

Brief 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. 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)

Conditions

Cardiovascular Surgery; Mobile Application; Patient Education

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

mobile application training group

The group that will be trained by downloading the mobile application to their mobile phones

Group Type: EXPERIMENTAL

mobile application training

Intervention Type: OTHER

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.

Interventions

mobile application training

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.

Intervention Type: OTHER

Eligibility Criteria

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.

for nurses;

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lokman Hekim University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Berrin Pazar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meltem Meriç, assoc prof

Role: STUDY_CHAIR

Lokman Hekim University

Kaan Kaya, assoc prof

Role: STUDY_DIRECTOR

Ankara Etlik City Hospital

Locations

Gulhane Medical Faculty

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023103

Identifier Type: -

Identifier Source: org_study_id