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临床试验/NCT06378970
NCT06378970已完成不适用

Effects of Audio Book Application on Anxiety and Vital Signs With Patients Who Receive NIMV Support

Ege University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2022年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Facial Anxiety Scale

研究概览

简要总结

Objectives: This study aimed to investigate the effect of audio book use on anxiety and vital signs in patients receiving non-invasive mechanical ventilation (NIMV) support.

Research Methodology/Design: It is an experimental-randomised controlled study. Settings: The study was carried out with patients hospitalised in the Chest Diseases Intensive Care Unit of a university hospital and NIMV support. The participants consisted of 60 people, 30 in the intervention group and 30 in the control group. Before starting the application in the intervention group, the book preferences of the patients were determined and the selected audio book was played to the patients with headphones via tablet/smartphone. No additional application was made to the control group.

Main Outcome Measures: Anxiety levels and vital signs in the intervention group were evaluated before, 15 minutes, 30 minutes and 30 minutes after the end of the intervention. In the control group, only routine care continued and anxiety levels, and vital signs were assessed simultaneously with the intervention group.

详细描述

Noninvasive mechanical ventilation (NIMV) is a method that provides positive-pressure respiratory support through a mask without the use of an endotracheal tube. In patients in intensive care units, various symptoms such as agitation, anxiety, and disorientation occur due to factors like constant monitoring, limited movement, painful interventions, intensive treatment protocols, and lack of information. Increased anxiety can result in the rejection of NIMV and may lead to unfavorable outcomes, including treatment failure and prolonged hospitalization.

Objectives: It is crucial to manage anxiety and monitor the resulting changes in vital signs in patients receiving NIMV support. In this context, distraction techniques can be employed by nurses to alleviate anxiety and enhance patient compliance with NIMV therapy. This study aimed to investigate the potential of audio books as a distraction technique to reduce anxiety and stabilize vital signs in patients undergoing NIMV support.

Study Design and Setting: The study employed an experimental-randomized controlled design. It was conducted with patients hospitalized in the Chest Diseases Intensive Care Unit of a university hospital who were receiving NIMV support.

Participants: The study sample consisted of 60 patients, with 30 assigned to the intervention group and 30 to the control group. To account for potential losses during the research process, the number of participants was increased by 25% above the minimum required sample size, setting the minimum sample size per group at 30 patients. Participants were numbered sequentially based on their hospital admission.

Intervention: Before initiating the intervention, the audio book preferences of the patients in the intervention group were determined. The selected audio book was played to the patients using headphones through a tablet or smartphone. No additional interventions were applied to the control group, which received only routine care.

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
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

入选标准

  • Not having been diagnosed with a neurological disease.
  • At least 6 hours have passed since admission to intensive care
  • Being administered NIMV at least once after admission to intensive care
  • Not having taken any action that would increase anxiety at least 2 hours before the use of NIMV
  • Using an ora-nasal mask
  • Not having been diagnosed with a psychiatric disease
  • Not having sedation treatment
  • Being hemodynamically stable
  • No hearing problems
  • Agreeing to participate in the research

排除标准

  • Refusing to participate in the research
  • Using a full face mask
  • Having deteriorated general condition

结局指标

主要结局

Facial Anxiety Scale

时间窗: before intervention, 15th minute of intervention, 30th minute of intervention 30 minute after intervention

The Facial Anxiety Scale is a measurement tool in which patients self-report their anxiety levels. It consists of five face shapes, the leftmost face expression indicates the absence of anxiety, while the level of anxiety increases towards the right (scored between 1-5). According to the Faces Anxiety Scale, a score of 3 and above by patients indicates that the level of anxiety is at medium and high levels the Faces Anxiety Scale is a valid means of measuring anxiety in intensive care patients.

Patient Follow-up Form

时间窗: before intervention, 15th minute of intervention, 30th minute of intervention 30 minute after intervention

It was prepared by the researcher. Haemodynamic parameters including systolic diastolic blood pressure, pulse rate, respiratory rate and oxygen saturation were included.

Audio Book Application Preference Form

时间窗: 4 month

It was prepared by the researchers.there are questions about the preferred book, listening time.

Patient Information Form

时间窗: 4 month

There are a total of 7 questions in the patient introduction form, including 4 questions on the socio-demographic characteristics of the patients (age, sex, education level, marital status) and 3 questions on the diagnosis of health status (diagnosis of hospitalisation, presence of chronic disease in addition to the diagnosis of hospitalisation, number of days of NIMV connection).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Oksel

Associate Professor

Ege University

研究点 (2)

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