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Digital Stimulation and Anxiety and Sleep Quality in Intensive Care Unit Patients

2026年9月11日 更新者:Esra Baser Akin、Cumhuriyet University

The Effect of Digital Visual and Auditory Stimulation on Anxiety and Sleep Quality in Patients Hospitalized in the Intensive Care Unit: A Randomized Controlled Trial

The aim of this study is to examine the effect of digital visual and auditory stimulation on anxiety and sleep quality in patients hospitalized in the intensive care unit (ICU).

The questions to be answered within the scope of the research are:

Does the application of digital visual and auditory stimulation to patients in intensive care units have a significant effect on anxiety levels? Does the application of digital visual and auditory stimulation to patients in intensive care units have a significant effect on sleep quality? Does the application of digital visual and auditory stimulation to patients in intensive care units have a combined effect on anxiety levels and sleep quality?

Participants will:

The patients will be divided into two groups: an intervention group and a control group. The intervention group will receive visual and auditory stimuli once a day, every morning for three days. Sleep quality and anxiety levels will be measured after the digital visual and auditory stimuli.

The control group will continue with routine intensive care unit follow-up treatments.

研究概览

详细说明

Patients in the intervention group will be administered a questionnaire, the Richards-Campbell Sleep Scale, and the Hospital Anxiety and Depression Scale as pre-tests. Following this, for three consecutive days, the research nurse will show the patient nature images (landscapes, lakes, mountains, etc.) via tablet for approximately 20-30 minutes once a day in the mornings when the patient is available. While watching the images, Johann Sebastian Bach's instrumental classical music pieces (60-80 bpm) will be played through headphones. The pieces to be used as digital visual and auditory stimuli will be selected by the art therapy specialist in the study. During the intervention, patients' vital signs and clinical condition will be closely monitored, and the intervention will be terminated if any discomfort, hemodynamic instability, or intolerance to the procedure develops. The digital visual and auditory stimulus application will continue under the same conditions for three days, and at the end of the third day, the Richards-Campbell Sleep Scale and the Hospital Anxiety and Depression Scale will be administered again as post-tests. Control Group Patients in the control group will also be administered the Demographic Information Form, the Richards-Campbell Sleep Scale (RCSQ), and the Hospital Anxiety and Depression Scale (HADS) at the beginning of the data collection process, at the same time as the intervention group. Patients in the control group will not undergo any intervention during the study period, and their routine intensive care treatment and care will continue. At the end of the third day, the Richards-Campbell Sleep Scale and the Hospital Anxiety and Depression Scale will be administered again as a final test, simultaneously with the intervention group.

研究类型

介入性

注册 (估计的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 18 years and above
  • Conscious [Glasgow Coma Scale(GCS)] ≥ 14)
  • Not connected to mechanical ventilation or receiving non-invasive support
  • Hearing and visual functions are sufficient
  • No communication problems
  • Able to answer questions correctly
  • Not under sedation
  • Expected to stay in the ICU for at least 48 hours

Exclusion Criteria:

  • Having a hearing or visual impairment
  • Being under sedation
  • Having impaired consciousness
  • Refusing to participate in the study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention Group: Digital Visual and Auditory Stimulation
Patients in the intervention group will receive visual and auditory stimuli once a day, every morning for three days. Visually, they will be shown landscape images on a tablet. Simultaneously, they will listen to classical music (60-80 bpm) through headphones. As a pre-test, patients in the intervention group will complete a questionnaire, the Richards-Campbell Sleep Scale, and the Hospital Anxiety and Depression Scale. These scales will also be administered as a post-test on the third day.
Visually, they will be shown landscape images on a tablet. Simultaneously, they will listen to classical music (60-80 bpm) through headphones.
无干预:Control Group: Usual Care
Patients in the control group will also be administered the Richards-Campbell Sleep Scale (RCSQ) and the Hospital Anxiety and Depression Scale (HADS) at the beginning of the data collection process, at the same time as the intervention group. Patients in the control group will not receive any intervention during the study; their routine intensive care treatment and care will continue. The scales will be administered simultaneously with the intervention group at the end of the third day.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Richards-Campbell Sleep Questionnaire (RCSQ)
大体时间:The sleep questionnaire will be administered upon admission to the intensive care unit on the first day of the study and at the end of the third day of the intervention.
The Richard-Campbell Sleep Scale (RCSS) is a scale developed by Richards in 1987 to assess the quality of nocturnal sleep in patients. Adapted into Turkish by Özlü and Özer, and subsequently validated and its reliability studied, the scale consists of six items that evaluate the depth of nocturnal sleep, time to fall asleep, frequency of awakenings, duration of wakefulness, quality of sleep, and ambient noise level. Each item is evaluated on a visual analog scale ranging from 0 to 100. A score of "0-25" indicates very poor sleep, while a score of "76-100" indicates very good sleep. As the scale score increases, the patients' sleep quality also improves. The Cronbach's α value of the scale was determined to be 0.82.
The sleep questionnaire will be administered upon admission to the intensive care unit on the first day of the study and at the end of the third day of the intervention.
Hospital Anxiety and Depression Scale (HADS)
大体时间:The scale will be administered as a first test during the initial interview at the beginning of the study and as a final test during the final interview at the end of the third day.
Developed by Zigmond and Snaith (1983) to determine a patient's risk of anxiety and depression, and to measure their level and severity, the scale's validity and reliability in Turkish were established by Aydemir et al. (1997). The scale contains 14 questions in total, with odd numbers measuring anxiety and even numbers measuring depression. The scale consists of two subscales: Anxiety (HAD-A) and Depression (HAD-D). In the validity and reliability study, the cutoff score for HAD-A was found to be 10/11, and for HAD-D, 7/8. Accordingly, scores above these points are considered at risk. The scale is a four-point Likert type, with a total score ranging from 0 to 42.
The scale will be administered as a first test during the initial interview at the beginning of the study and as a final test during the final interview at the end of the third day.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月14日

初级完成 (估计的)

2027年2月14日

研究完成 (估计的)

2027年2月21日

研究注册日期

首次提交

2026年9月6日

首先提交符合 QC 标准的

2026年9月11日

首次发布 (实际的)

2026年9月15日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 12.08.2026-50534

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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