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NCT Number: NCT06677476

Development of a Mobile Application and Determination of Its Effects

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiovascular Surgery Mobile Application Patient Education

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulhane Medical Faculty

Ankara, Turkey (Türkiye)

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mobile application training

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Lokman Hekim University

Other Gov

Registry information

Official study title

Developing and Determining the Effect of Mobile Application for Patients Who Will Have Cardiac Surgery and Cardiovascular Surgery Intensive Care Unit Nurses

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 6, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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