Caregivers Tracheal Aspiration Training

November 30, 2023 updated by: Yeliz Sapulu Alakan, Uludag University

Evaluation of the Effectiveness of the Simulation Model and Mobile Application in Teaching Tracheostomy Aspiration Application to the Caregivers of Patients With Tracheostomy and Tracheotomy

The aim of this study is to determine the effects of animation-based mobile application and simulation-based training methods on tracheal aspiration knowledge and skills of patient relatives who care for patients with tracheostomy/tracheotomy. Experimental pre-test-post-test control group study design was planned.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study aims to determine the effect of tracheal aspiration training given to caregivers of patients with tracheostomy and tracheotomy. The effects of training given using clinical routine training, animation-based mobile application and simulation-based training methods on the knowledge and skills of caregivers will be evaluated. Experimental pre-test-post-test control group study design was planned. This study will be carried out as a multicenter in Bursa, Turkey.The centers where the study will be conducted are Bursa Uludağ University Health Research and Application Center and Bursa City Hospital. In calculating the sample size, the effect size was determined as 0.4 for 80% power and 5% significance level. In this direction, it is aimed to include 22 patient relatives in each group in order to compare the knowledge and skill levels between the mobile application, simulation training and control groups. A total of 66 patient relatives will be included in the study. The caregivers to be assigned to the groups will be selected using the block randomized method.

The plan to be implemented in the research;

  1. Pre-Training: "Introductory Characteristics Form" and "Information Evaluation Form" will be filled in for caregivers in all groups.

  2. Training: An animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher Yeliz ŞAPULU ALAKAN.

    Tracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher Yeliz ŞAPULU ALAKAN. It will be shown in practice on the tracheostomy care simulator.

    Caregivers assigned to the "control group" will not undergo any training other than routine in-clinic training on tracheostomy aspiration.

    Caregivers in the all group will also undergo routine training of the clinic

  3. After the training: Caregivers in all groups will fill out the "Training Evaluation Form" and "Information Evaluation Form." The video of the caregiver taken during the tracheal aspiration procedure will be evaluated by the researchers using the "Skill Evaluation Form".
  4. One month after the training: Caregivers in all groups will fill in the "Information Evaluation Form" and "Result Evaluation Form".The video of the caregiver taken during the tracheal aspiration procedure will be evaluated by the researchers using the "Skill Evaluation Form".

Study Type

Interventional

Enrollment (Actual)

66

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

  • Turkey
      • Bursa, Turkey, 16000
        • Bursa Uludag University
    • Nilüfer
      • Bursa, Nilüfer, Turkey
        • Yeliz

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being the primary caregiver of the patient who will undergo a tracheotomy or tracheostomy, which is expected to last at least one month,
  • Primary care will be continued by the same caregiver for a period of one month.
  • Volunteering to participate in the research
  • Being over 18 years old,
  • Absence of a diagnosed psychiatric illness that may interfere with communication
  • Owning and being able to use a smart mobile phone

Exclusion Criteria:

  • Not being the primary caregiver of the patient who will undergo tracheostomy or tracheotomy,
  • Change of primary caregiver in less than a month
  • Closing the tracheotomy in less than a month
  • Not volunteering to participate in the research
  • Be under the age of 18,
  • Having a diagnosed psychiatric illness that may interfere with communication
  • Not having or being unable to use a smart mobile phone

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1-simulation model training
Tracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher. It will be shown in practice on the tracheostomy care simulator. They will also receive clinical routine training
Other: simulation model training
Tracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher. It will be shown in practice on the tracheostomy care simulator.
Other: control group
Clinical routine training will be given to caregivers in this group.
Other: 2-mobile app training
An animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher. They will also receive clinical routine training
Other: control group
Clinical routine training will be given to caregivers in this group.
Other: mobile app training
An animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher.
Other: 3-control group
Clinical routine training will be given to caregivers in this group.
Other: control group
Clinical routine training will be given to caregivers in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the effects of simulation model, mobile application and routine training methods on the knowledge scores of the caregivers of patients with tracheostomy before the training, after the training and one month after the training.
Time Frame: through study completion, an average of 1 year
Getting at least 50 points from each part of the "knowledge evaluation form", which includes questions about the procedure.
through study completion, an average of 1 year
To determine the effects of simulation model, mobile application and routine training methods on the skill levels of caregivers of patients with tracheostomy before, after and one month after training.
Time Frame: through study completion, an average of 1 year
Caregivers will be evaluated according to the "skill evaluation form" during the aspiration process from the tracheostomy.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with different training methods
Time Frame: through study completion, an average of 1 year
To be measured using the "Satisfaction Evaluation Form"
through study completion, an average of 1 year
One month after the different trainings, the effects of caregivers on the aspiration application will be evaluated using the "Results Evaluation Form".
Time Frame: through study completion, an average of 1 year
The effect of different training methods will be evaluated.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Uludag University

Investigators

  • Principal Investigator: yeliz Şapulu Alakan, Uludag Üniversty
  • Study Director: Neriman Akansel, Uludag Üniversty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

June 3, 2022

Primary Completion (Actual)

August 10, 2023

Study Completion (Actual)

August 10, 2023

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 28, 2022

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Uludag Universty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD

IPD Sharing Time Frame

After the research is published

IPD Sharing Access Criteria

It will be shared by researcher Yeliz ŞAPULU ALAKAN to be used in meta analysis or other research.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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.

Clinical Trials on Tracheostomy

Clinical Trials on simulation model training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe