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临床试验/NCT06297356
NCT06297356Unknown不适用

Investigation of the Effect of Stress Ball Utilisation on Treatment Duration, Dyspnoea Severity and Anxiety Level in Patients Receiving Nebuliser Therapy: A Randomised Controlled Study

Kirsehir Ahi Evran Universitesi2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
dyspnea severity

研究概览

简要总结

Nebul Therapy is very effective in quickly improving the symptoms of respiratory system diseases. While applying this treatment, patients are expected to complete a sufficient period of time. However, this waiting and the symptoms of the disease may cause anxiety in the patient.

The aim of the study was to enable patients to spend their nebul period actively by using a stress ball. Thus, it was thought that it would make a positive contribution to dyspnea severity and anxiety levels.

The main questions it aims to answer are:

Does using a stress ball contribute positively to nebulizer usage time? Is the use of a stress ball effective in reducing the severity of dyspnea? Is using a stress ball effective in reducing anxiety levels?

For this purpose, participants will be asked to tighten and loosen the stress ball with one hand during the nebuliser therapy.

They will be expected to continue this with at least two nebuliser therapy per day. A control group will be used to determine the effectiveness of the stress ball. This group will not use a stress ball while receiving nebulizer treatment.

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
Single (Participant)

入排标准

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

入选标准

  • Hospitalized for at least three days
  • Having nebulizer treatment at least twice a day
  • Medicines that have the same effect as prescribed (bronchodilators)
  • Patients who are required to have at least 4 ml of medication in the reservoir
  • Patients who have previous experience of using a nebulizer at home

排除标准

  • Those who have severe exacerbation attacks
  • People with speech problems
  • People who experience severe dyspnea due to heart disease
  • Those with high anxiety levels for any reason (death of a relative, etc.)
  • Those with muscle or nerve problems in their hands
  • Those who did not consent to participate in the study

研究组 & 干预措施

intervention

Experimental

This group will use a stress ball during nebuliser therapy. This process will be repeated at least twice a day.It will be a single application since the patients' current dyspnea and anxiety levels will be evaluated.

干预措施: Stress ball (Device)

Control

No Intervention

Patients in this group will receive nebuliser therapy at least twice a day. However, no intervention will be made in the meantime. Measurements will be taken before and after any nebulizer treatment.

结局指标

主要结局

dyspnea severity

时间窗: Through study completion, an average of 4 months.

The patient's current dyspnea level is evaluated between 0-10. As it approaches 10, the intensity increases. The patient's dyspnea severity will be recorded before and after nebuliser therapy. This process will be done once.

anxiety levels

时间窗: Through study completion, an average of 4 months.

describes the patient's current anxiety level. The patient's current anxiety level is determined with the state anxiety scale developed for this purpose. The patient's anxiety levels will be recorded before and after nebuliser therapy. This process will be done once.

treatment duration

时间窗: Through study completion, an average of 4 months.

Defines the time between the start and end of nebuliser therapy. It is expected to be approximately 15-20 minutes. The patient's current condition will be measured. For this reason, it will be applied once.

次要结局

  • Vital signs: Respiratory rate(Through study completion, an average of 4 months.)
  • Vital signs: Blood pressure(Through study completion, an average of 4 months.)
  • Vital signs: Pulse(Through study completion, an average of 4 months.)
  • saturation(Through study completion, an average of 4 months.)

研究者

发起方
Kirsehir Ahi Evran Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin CEYHAN

Assistant Proffesor

Kirsehir Ahi Evran Universitesi

研究点 (2)

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