Caregivers Tracheal Aspiration Training

NCT ID: NCT05434442

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-03

Study Completion Date

2023-08-10

Brief Summary

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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.

Detailed Description

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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".

Conditions

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Tracheostomy Family Caregivers Aspiration

Keywords

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Family Caregivers Tracheostomy aspiration Mobile application Simulation training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Caregivers will be assigned to control, simulation and mobile application groups by block randomization method. An equal number of caregivers from each clinic will be assigned to each group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Caregivers will be assigned to control, simulation and mobile application groups by block randomization method, and communication between groups will be controlled. Caregivers assigned to groups by block randomization method will be numbered. Skill evaluation videos will be taken by a researcher. Skill assessments will also be made by another blinded researcher to the groups.

Study Groups

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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

Group Type OTHER

simulation model training

Intervention Type OTHER

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.

control group

Intervention Type OTHER

Clinical routine training will be given to caregivers in this group.

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

Group Type OTHER

mobile app training

Intervention Type OTHER

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.

control group

Intervention Type OTHER

Clinical routine training will be given to caregivers in this group.

3-control group

Clinical routine training will be given to caregivers in this group.

Group Type OTHER

control group

Intervention Type OTHER

Clinical routine training will be given to caregivers in this group.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

control group

Clinical routine training will be given to caregivers in this group.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uludag University

OTHER

Sponsor Role lead

Responsible Party

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Yeliz Sapulu Alakan

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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yeliz Şapulu Alakan

Role: PRINCIPAL_INVESTIGATOR

Uludag Universty

Neriman Akansel

Role: STUDY_DIRECTOR

Uludag Universty

Locations

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Yeliz

Bursa, Nilüfer, Turkey (Türkiye)

Site Status

Bursa Uludag university

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Bayram SB, Caliskan N. Effect of a game-based virtual reality phone application on tracheostomy care education for nursing students: A randomized controlled trial. Nurse Educ Today. 2019 Aug;79:25-31. doi: 10.1016/j.nedt.2019.05.010. Epub 2019 May 9.

Reference Type BACKGROUND
PMID: 31102793 (View on PubMed)

Loerzel VW, Crosby WW, Reising E, Sole ML. Developing the Tracheostomy Care Anxiety Relief Through Education and Support (T-CARES) Program. Clin J Oncol Nurs. 2014 Oct;18(5):522-7. doi: 10.1188/14.CJON.522-527.

Reference Type BACKGROUND
PMID: 25253106 (View on PubMed)

Other Identifiers

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Uludag Universty

Identifier Type: -

Identifier Source: org_study_id