Caregivers Tracheal Aspiration Training

Tracheostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05434442
• Other study ID #: Uludag Universty
• Status: Completed
• Phase: N/A
• Start date: June 3, 2022
• Est. completion date: August 10, 2023

Study information

• Verified date: November 2023
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspiration
• Family Caregivers
• Tracheostomy

Intervention

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

Locations

Country	Name	City	State
Turkey	Bursa Uludag university	Bursa
Turkey	Yeliz	Bursa	Nilüfer

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

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

External Links

•   A Caregiver Guide for Tracheostomy Care at Home
•   Caregiver's Guide To Respiratory Care In The Home Adult.
•   Guidelines for the Care of Patients with Tracheostomy Tubes
•   Tracheostomy Teaching Package For Parents And Carers Assessment.