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临床试验/NCT05640739
NCT05640739撤回不适用

The Effect of Demonstration and Video Viewing Education on Metered Dose Inhaler Usage Skills in Asthma Patients: A Randomized Controlled Study

Hasan Kalyoncu University1 个研究点 分布在 1 个国家开始时间: 2022年12月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
MDI Use Skills Chart

研究概览

简要总结

In the treatment of respiratory diseases such as COPD and asthma, bronchodilators and steroids, which are essential drugs, are preferred to be administered by inhalation compared to oral and parenteral routes. In the studies conducted with the use of inhaler drugs, it is seen that many wrong practices have been made regarding the techniques of using the inhaler drugs and that the correct usage techniques are not followed. Inability to use the inhaler device fully and correctly; It causes consequences such as failure to control the disease, increase in drug use and side effects, increase in exacerbations, high hospitalization and waste of drugs, both undermining the trust in treatment and putting an extra burden on the health expenditures of the countries. This research aim is to evaluate the effectiveness of the training given with the demonstration method and video watching method for the use of the Metered Dose Inhaler (MDI) in asthmatic patients, and to ensure that the patients learn the correct inhaler use techniques.

详细描述

The research was planned as a randomized controlled experimental study. Patients who applied to the Elbistan State Hospital chest polyclinic with a diagnosis of asthma and met the criteria for inclusion in the study will be divided into control group, demonstration training group and video surveillance training groups. Simple randomization method will be used to determine the groups. The sample of the research; With G-Power, it was determined as 21 people for each group at 80% power, 5% error and 95% confidence interval. To prevent data loss; It was decided to have 32 people in the control group, 32 people in the demonstration training group, and 32 people in the video watching training group. After informing the patients about the study, the consent of the patients who agreed to participate in the study will be obtained and the research data will be collected by face-to-face interview method. After the patient identification form is completed, the patients will be asked to use the MDI inhaler and the MDI use skills chart will be filled. For the steps of MDI use, it will be evaluated with the use of MDI skill chart based on the Thoracic Society National Asthma Diagnosis and Treatment Guidelines. The total skill scores will be determined by giving 1 point for the correct application and 0 points for the incorrect application. Data will be collected from the patients in the control group without any application and their ability to use MDI will be evaluated. Patients in the demonstration group will be given inhaler training (practically) by the researcher. The training will include steps compatible with the video. The training will be completed by watching the MDI usage video prepared by the researchers in the patients in the video group. After the training, the patients will be asked to use the inhaler again, and their skill scores will be re-evaluated, and the mistakes made by the patients will be shown by the researcher in the demonstration group, and in the video group by allowing them to watch the video again. The patients in the control group will fill out the MDI skill form again (after 30 minutes) without any procedure. To prevent drug overdose, patients will be administered with placebo training drugs. The patients in the whole group will be called by the researcher on the 7th day of the study, and the patients will be asked to use their MDI drugs again, and the MDI use skill chart will be filled again. The control group will then be given inhaler training by the researchers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

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

  • •Have a confirmed asthma diagnosis
  • •be 18 years or older,
  • •Using MDI,
  • •Volunteer to participate in the research.
  • •Patients who do not have communication problems,
  • •Patients who can make video calls,

排除标准

  • •Not complying with the principle of volunteering
  • •Answering data collection forms incompletely
  • •Patients who did not answer calls for the last test and could not be reached

研究组 & 干预措施

Control group patients

No Intervention

Data will be collected from the patients in the control group without any application and their ability to use MDI will be evaluated.

Demonstration group patients

Experimental

Patients in the demonstration group will be given inhaler training (practically) by the researcher. The training will include steps compatible with the video. After the training, the patients will be asked to use inhaler drugs again, and their skill scores will be re-evaluated and the mistakes made by the patients will be shown by the researcher in the demonstration group. On the 7th day of the study, the patients will be called by the researcher with a video call, and the patients will be asked to use their MDI drugs again, and the MDI use skill chart will be filled again.

干预措施: Demonstration method for the use of the Metered Dose Inhaler (Behavioral)

Video group patients

Experimental

The patients in the video group will be shown the video of using MDI prepared by the researchers. The training will be completed by watching the MDI usage video prepared by the researchers in the patients in the video group. After the training, the patients will be asked to use the inhaler again and their skill scores will be re-evaluated. Their mistakes will be shown by making them watch it again from the video. On the 7th day of the study, the patients will be called by the researcher with a video call, and the patients will be asked to use their MDI drugs again, and the MDI use skill chart will be filled again.

干预措施: Video watching method for the use of the Metered Dose Inhaler (Behavioral)

结局指标

主要结局

MDI Use Skills Chart

时间窗: 7th day after training

For the steps of MDI use, it will be evaluated with the use of MDI skill chart based on the Thoracic Society National Asthma Diagnosis and Treatment Guidelines. The total skill scores will be determined by giving 1 point for the correct application and 0 points for the incorrect application.

MDI Use Skills Chart

时间窗: Baseline (Before training)

For the steps of MDI use, it will be evaluated with the use of MDI skill chart based on the Thoracic Society National Asthma Diagnosis and Treatment Guidelines. The total skill scores will be determined by giving 1 point for the correct application and 0 points for the incorrect application.

MDI Use Skills Chart

时间窗: Immediately after training

For the steps of MDI use, it will be evaluated with the use of MDI skill chart based on the Thoracic Society National Asthma Diagnosis and Treatment Guidelines. The total skill scores will be determined by giving 1 point for the correct application and 0 points for the incorrect application.

次要结局

未报告次要终点

研究者

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

Yasemin SAZAK

Principal Investigator

Hasan Kalyoncu University

研究点 (1)

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