跳至主要内容
临床试验/NCT05434442
NCT05434442已完成不适用

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

Uludag University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
2
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

1-simulation model training

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. They will also receive clinical routine training

干预措施: simulation model training (Other)

1-simulation model training

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. They will also receive clinical routine training

干预措施: control group (Other)

2-mobile app training

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. They will also receive clinical routine training

干预措施: mobile app training (Other)

2-mobile app training

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. They will also receive clinical routine training

干预措施: control group (Other)

3-control group

Other

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

干预措施: control group (Other)

结局指标

主要结局

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.

时间窗: 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.

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.

时间窗: 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.

次要结局

  • Satisfaction with different training methods(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".(through study completion, an average of 1 year)

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeliz Sapulu Alakan

Lecturer

Uludag University

研究点 (2)

Loading locations...

相似试验