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临床试验/NCT07007754
NCT07007754已完成不适用

Effects of Voice Records on Vital Signs, Pain and Serum Cortisol Levels in Surgical Intensive Care Unit: Randomized-controlled Study

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2021年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
69
试验地点
2
主要终点
Pain level

研究概览

简要总结

This randomized kontrolled study is aimed to contribute to the literature on recognising, evaluating and reducing stress in the intensive care unit, which is one of the main responsibilities of surgical nurses, and to increase awareness on the subject.

详细描述

The condition of having surgery, the severity of the disease, being admitted to the intensive care unit in the postoperative period and the presence of many invasive interventions in the body, intense feelings of pain and fear, loss of autonomy, helplessness, and fear of death create a heavy physical, psychological and emotional burden on patients undergoing surgery. All these factors increase the stress level in the patient by causing many metabolic and hormonal changes, and as a result of this stress response, negative conditions such as hyperglycaemia, delay in recovery, and decreased immunity can be seen.

Nurses have main roles and responsibilities in intensive care settings such as caring for patients, participating in treatment, informing and counselling patients and their relatives. Within the scope of these roles and responsibilities, nurses should be aware of the stress experienced by patients, recognise the factors that may cause stress, plan, implement and evaluate basic nursing interventions such as increasing coping strategies and social support in the management and alleviation of stress, informing and counselling, increasing the patients orientation, and enabling the patient to participate in care in order to reduce the level of stress experienced by patients and protect their physical and biopsychosocial integrity.

There are no studies in the literature examining the effects of listening to audio recordings, which is an easy, inexpensive and non-pharmacological intervention for stress management of patients in intensive care units.

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 (Outcomes Assessor)

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

  • To determined as being over 18 years of age,
  • To staying in the ICU for at least two hours,
  • To being hospitalised in the ICU for the first time,
  • To being able to speak and understand Turkish.

排除标准

  • To determined as being pregnant,
  • To having a diagnosis of neurological/psychiatric disorder,
  • To having hearing problems,
  • To using cortisol-derived drugs,
  • To having a disease that may affect serum cortisol level, exhibiting agitated behaviour and
  • To experiencing intense nausea and vomiting.

结局指标

主要结局

Pain level

时间窗: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.

A numerical rating scale was used to evaluate the pain. The scale was marked from 0 to 10 based on the patient's self-report. 0 indicates no pain, while 10 points indicates unbearable pain.

Blood pressure

时间窗: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.

Since the patients were monitored in the intensive care unit and invasive blood pressure measurements were performed, the values monitored on the Mindray patient monitor were added to the data collection form.

Serum cortisol level

时间窗: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.

The serum cortisol level in the blood was reported in an independent private laboratory by taking a blood sample.

Blood glucose level

时间窗: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.

The blood glucose level was assessed using Gluko Navi brand glucometer with fingertip measurement.

Hearth rate

时间窗: Postoperative 1st, 2nd and 3rd days at 06:00 A. M.

Since the patients were monitored in the intensive care unit and pulse rate was measured, the values monitored on the Mindray patient monitor were added to the data collection form.

次要结局

未报告次要终点

研究者

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

Ezgi Arslan

PhD, Research Assisstant (Principal Investigator)

Aydin Adnan Menderes University

研究点 (2)

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