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临床试验/NCT05038514
NCT05038514已完成不适用

The Effect of Music Therapy on Adaptation and Anxiety Levels in COVID-19 Patients Given Prone Position: A Triple-blind Randomized Controlled Clinical Trial

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月1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
30
试验地点
1
主要终点
prone position adaptation

研究概览

简要总结

Almost half of the patients diagnosed with COVID-19 pneumonia develop ARDS and most of these patients are treated in the intensive care unit. In the management of COVID-19 ARDS, prone position is applied to improve physiological parameters by facilitating better distribution of tidal volume and drainage of secretions. It has been reported that awake patients in COVID clinics could not adapt their prone position due to anxiety . Jiang et al (2020) reported that awake patients may not tolerate the prone position and may experience anxiety due to posture habits and discomfort.

It was determined that anxiety developed on the second day of hospitalization in the intensive care unit, state anxiety was associated with trait anxiety and pain, and anxiety was low in patients receiving mental health care/treatment . And also not to change position himself of patient in prone position due to care equipment etc it can cause loss of self-control and anxiety. Twelve-sixteen hour prone position recommendation for clinical improvement, positioning difficulties in patients who cannot position themselves may also trigger anxiety in awake patients It has been suggested that music therapy may be effective in reducing anxiety related to weaning from mechanical ventilation in COVID-19 patients. Music therapy intervention in ICU has been tested in sessions of at least 30 minutes, 1-30 days, with options such as western music, classical Chinese music, nature-based music. In the study of Chu and Zhang (2021), it was shown that the recovery time for tomography findings, the number of days of hospital stay and the rates of transfer to the intensive care unit were lower in the patient group who received holistic mode including traditional Chinese medicine, music therapy, and emotional support in COVID-19 patients. Studies evaluating the effectiveness of music therapy alone in the COVID-19 intensive care process could not be reached. It is thought that music therapy applied in the prone position in the COVID-19 intensive care unit will reduce the anxiety of the patients, adapt to the prone position and improve their clinical parameters.

详细描述

The Corona virus disease 2019 Pandemic (COVID-19) has caused a psychosocial depression in the world. Acute severe or critical condition has been observed in 20% of individuals diagnosed with COVID-19. It is stated that viral pneumonia or Acute Respiratory Distress Syndrome (ARDS) and organ failures develop in these individuals. Almost half of the patients diagnosed with COVID-19 pneumonia develop ARDS and most of these patients are treated in the intensive care unit. In the management of COVID-19 ARDS, prone position is applied to improve physiological parameters by facilitating better distribution of tidal volume and drainage of secretions. It is thought that the prone position will be more effective in the early stages of the disease and awake patients. It is recommended that the prone position especially in moderate to severe ARDS cases be applied for at least 12 hours after symptoms stabilize. Elkattawy and Noori (2020) reported that at least 6-8 hours of prone position improves oxygenation in the COVID-19 case without ARDS criteria. Mac Sweeney et al. (2020) reported that clinical parameters improved, intubation and ventilator requirement were delayed in an awake, self-prone COVID-19 case. However, Somagutta et al (2021) reported anxiety, back pain, adjustment and tolerance problems in awake and not mechanically ventilated patients. Bastoni et al, in the study which they evaluated prone adapt at emergency department in Italy; it is reported positioning could not be maintained in four out of ten patients due to unconformity, pain, and rejection of prone position. It has been reported that awake patients in COVID clinics could not adapt their prone position due to anxiety. Jiang et al (2020) reported that awake patients may not tolerate the prone position and may experience anxiety due to posture habits and discomfort.

It was determined that anxiety developed on the second day of hospitalization in the intensive care unit, state anxiety was associated with trait anxiety and pain, and anxiety was low in patients receiving mental health care/treatment. And also not to change position himself of patient in prone position due to care equipment etc it can cause loss of self-control and anxiety. Twelve-sixteen hour prone position recommendation for clinical improvement, positioning difficulties in patients who cannot position themselves may also trigger anxiety in awake patients.

Music therapy is applied as a non-pharmacological nursing intervention in the anxiety management of patients in intensive careIt is stated that music therapy is effective in stress-anxiety management, improves vital signs and sleep quality, and may have a muscle relaxant effect in interventions applied in covid-19. It has been suggested that music therapy may be effective in reducing anxiety related to weaning from mechanical ventilation in COVID-19 patients. Music therapy intervention in ICU has been tested in sessions of at least 30 minutes, 1-30 days, with options such as western music, classical Chinese music, nature-based music. It has been reported that music therapy applied with all types of music provides normal heart rate, respiratory recovery and muscle relaxation. Golino et al. listened to music for 30 minutes according to the preferences of the patients in the intensive care unit and their vital signs, pain and anxiety were evaluated. While there was an improvement in heart rate and respiration, oxygen saturations did not change. At the same time, patients reported less pain and anxiety. In the study of Chu and Zhang (2021), it was shown that the recovery time for tomography findings, the number of days of hospital stay and the rates of transfer to the intensive care unit were lower in the patient group who received holistic mode including traditional Chinese medicine, music therapy, and emotional support in COVID-19 patients. Studies evaluating the effectiveness of music therapy alone in the COVID-19 intensive care process could not be reached. It is thought that music therapy applied in the prone position in the COVID-19 intensive care unit will reduce the anxiety of the patients, adapt to the prone position and improve their clinical parameters.

Objective

The aim of this study is to evaluate the effect of music therapy applied in the prone position on anxiety, compliance with the prone position, and vital signs in patients diagnosed with COVID-19 in the intensive care unit.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Triple-blind (i.e., triple-masking) studies are randomized experiments in which the treatment or intervention is unknown to (a) the research participant, (b) the individual(s) who administer the treatment or intervention, and (c) the individual(s) who assess the outcomes

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients between the ages of 18-80
  • •Developing respiratory failure due to COVID-19
  • •Prone position applied
  • •Staying in intensive care unit for at least 24 hours
  • •Awake and cooperative
  • •Recipient of oxygen mask or high-flow oxygen therapy or noninvasive mechanical ventilation support
  • •Stable hemodynamic status

排除标准

  • •Those who do not agree to participate in the research
  • •Those with communication barrier problems
  • •Intubated
  • •Sedation drug applied
  • •Those who need emergency intervention during work
  • •Having a diagnosis of neurological and psychological medicine
  • •Abnormal deterioration in physiological parameters
  • •Patients transferred to another service or discharged
  • •patients with hearing impairment

研究组 & 干预措施

music therapy

Experimental

Music therapy intervention, bluetooth headphones will be applied in the intensive care unit and will be disinfected after the application. The intervention consists of a 30-minute, single-session, nature-based music concert. the music concert is calibrated by the audiologist (60 decibels). During nature-based music listening, patients will be asked to close their eyes, rest and follow the sound flow.

干预措施: musıc therapy (Other)

control

No Intervention

The control group will be given the prone position and music therapy will not be applied.

结局指标

主要结局

prone position adaptation

时间窗: time/hour to stay in prone position at one day

length of stay in prone position

anxiety

时间窗: change from baseline state anxiety after position change at one day

State Anxiety Inventory

vital signs

时间窗: change from baseline oxygen saturation after position change at one day

oxygen saturation

vital signs

时间窗: change from baseline pulse rate after position change at one day

pulse rate

vital signs

时间窗: change from baseline respiratory rate after position change at one day

respiratory rate

vital signs

时间窗: change from baseline blood pressure after position change at one day

blood pressure

次要结局

未报告次要终点

研究者

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

Senay Takmak

Assistant professor

Kutahya Health Sciences University

研究点 (1)

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