An interventional study of simulation model training and mobile app training in Tracheostomy, Family Caregivers and Aspiration, sponsored by Uludag University. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-04.
Sponsored by Uludag University · Not applicable, Interventional, and Supportive care
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.
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;
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
Uludag University is the lead sponsor of 145 studies on the registry; 39 are open to participants now.
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Exclusion Criteria:
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 · Other: control group
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: mobile app training · Other: control group
Clinical routine training will be given to caregivers in this group.
Other: control group
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.
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.
Clinical routine training will be given to caregivers in this group.
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.
Time frame: 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.
Caregivers will be evaluated according to the "skill evaluation form" during the aspiration process from the tracheostomy.
Time frame: through study completion, an average of 1 year
Satisfaction with different training methods
To be measured using the "Satisfaction Evaluation Form"
Time frame: 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".
The effect of different training methods will be evaluated.
Time frame: through study completion, an average of 1 year
Plan to share: Yes — all collected IPD
Supporting information: Study protocol, Clinical study report
Time frame: After the research is published
Access criteria: It will be shared by researcher Yeliz ŞAPULU ALAKAN to be used in meta analysis or other research.
Ran from Jun 2022 to primary completion in Aug 2023, 14 months.
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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