NCT06677476

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2024Oct 2026

Study Start

First participant enrolled

October 15, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

1.1 years

First QC Date

October 25, 2024

Last Update Submit

November 5, 2024

Conditions

Keywords

Intensive care nursingSurgery NursingNursing CareHeart surgeryMobile application development

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    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

    1st day after surgery

Other Outcomes (1)

  • satisfaction with mobile application

    after using the app (1st day after surgery)

Study Arms (1)

mobile application training group

EXPERIMENTAL

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

Other: mobile application training

Interventions

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.

mobile application training group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • having emergency surgery,
  • having previously been treated in the ICU,
  • wanting to leave the study at any stage of the project.
  • for nurses;
  • working in the cardiovascular surgery ICU,
  • being a volunteer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Medical Faculty

Ankara, Turkey (Türkiye)

Location

Study Officials

  • Meltem Meriç, assoc prof

    Lokman Hekim University

    STUDY CHAIR
  • Kaan Kaya, assoc prof

    Ankara Etlik City Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Training will be given on the mobile application to be downloaded to the mobile phone.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 25, 2024

First Posted

November 6, 2024

Study Start

October 15, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

November 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations