NCT05094063

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

October 13, 2021

Last Update Submit

October 23, 2021

Conditions

Keywords

open heart surgerysurgical nursingpatient education

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in Postoperative Recovery Index (PoRI) at month 3

    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.

    Baseline and month 3

  • Change from baseline in Psychological Well-Being at month 3

    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.

    Baseline and month 3

Secondary Outcomes (1)

  • Change from baseline in StateTrait Anxiety Inventory at month 3

    Baseline and month 3

Study Arms (2)

experimental group

EXPERIMENTAL

Training will be given to the patients in the experimental group.

Other: patient education by mobile application

control group

NO INTERVENTION

untrained patient group

Interventions

Training will be given to the patients in the experimental group.

experimental group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • voluntarily accepting to participate in the study
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (3)

  • Fredericks S, Yau TM. Educational interventions for adults to prevent readmission and complications following cardiovascular surgery. Cochrane Database of Systematic Reviews 2012, Issue 9.

    BACKGROUND
  • 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.

    BACKGROUND
  • Akyolcu N, Kanan N, Güler A. Cerrahi Hemşireliği II, 1. Baskı. İstanbul, Nobel Tıp Kitapevleri, 2017: 101-114.

    BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: This research was planned as an experimental randomized controlled trial. Randomization will be done using a computer program. With the computer program (www.randomizer.org), the participants will be divided into 2 subgroups (group 1: patient education group; group 2: patient education group not provided). With the randomization program, the order of the experimental and control groups will be provided.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2021

First Posted

October 26, 2021

Study Start

September 1, 2021

Primary Completion

October 1, 2022

Study Completion

February 1, 2023

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations