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临床试验/NCT05518955
NCT05518955已完成不适用

Strategies Establishment for Promoting Sleep Quality and Quantity of Patients Requiring Intensive Care: Verifying the Effect of Virtual Reality Integrated Into Multicomponent Interventions

Hsiao-Yean Chiu1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Changes in subjective sleep quality from first day to 3rd day of ICU recruitment

研究概览

简要总结

Background: The patients who are admitted to ICUs mostly experience sleep disturbance. Seeking an effective strategy and integrating it into the daily routine is of clinical importance. Therefore, we aim to examine the effects of guided virtual reality integrated into the multicomponent program (SLEEP care) on sleep quality and quantity in critically ill patients. This will be a randomized controlled trial with assessor-blinded and two-arm parallel-group design. A total of 120 critical ill adults will be randomly allocated to the SLEEP care group and eyemask groups in a 1:1 ratio (60 participants in each group).

详细描述

This study is expected to enroll 120 critically ill patients. We will collect basic data on the first day of admission to the intensive care unit, including demographics and disease characteristics, pain, anxiety, and stress, sleep quality and quantity, measure 5-minute HRV, wear an actigraph watch, and connect to the on-lead EEG sensor, and attach the brain wave to monitor the brain wave and sleep cycle. Then they will be randomly assigned 1:1, dividing into SLEEP care group and eyemask group. Participants who are in the control will receive eyemask intervention and daily care in the ICU. Participants who are assigned to the SLEEP care group will receive the VR and night sleep promotion routine. The researcher will assist participants to wear a virtual reality helmet for a 30-minute program at 10 pm, and then remove the helmet and wear eye masks until 6:30 in the morning. The ICU routine care of promoting sleep is still maintained. The next morning (the second day of the ICU), the researcher will assist participants to remove EEG sensors and evaluate the RCSQ scale to understand the previous night's sleep. The above process will repeat for three days (ICU days 1 to 3) until the intervention and measurement during the intensive care unit are completed on the morning of the fourth day. In order to understand the impact of sleep on cognitive function during the stay in the intensive care units and after discharge, the PSQI, VAS of pain, anxiety, and stress (confounders), and MOCA will be evaluated in the first and sixth months after discharge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Aged 20 years and above.
  • Conscious and able to communicate with Chinese or Mandarin.
  • To stay in ICU at least 72 hrs

排除标准

  • The medical history of sleep disorder, cognition impairment, psychiatric disorders, seizures, visual difficulty or hearing difficulty
  • The APACHE II score over than 25
  • The participates who are delirium

结局指标

主要结局

Changes in subjective sleep quality from first day to 3rd day of ICU recruitment

时间窗: The 1st to 3rd day of ICU recruitment

Subjective sleep quality in ICU is assessed by Richards-Campbell Sleep Questionnaire(RCSQ). The mean of total score is 0-100. The higher score means the better sleep quality.

Change of objective sleep from 1st day to 3rd day of ICU recruitment

时间窗: The 1st day to 3rd day of ICU recruitment

Objective sleep quality in ICU is measured by actigraphy

Change of subjective sleep quality from before ICU and admission for 30 and 180 days after ICU discharge

时间窗: The 1st day of ICU recruitment, 30 and 180 days days after ICU discharge

sleep quality is assessed by Pittsburgh Sleep Quality. Index(PSQI). The total score is 0-21. The higher score means the worse sleep quality.

次要结局

  • Change of quality of life from the first day of ICU recruitment, 30 and 180 day after ICU discharge(The 30 and 180 days after ICU discharge)
  • Delirium occurrence(The 1st to 3th days of ICU recruitment)
  • Change of stress(The 1st day of ICU recruitment, 30 and 180 days after ICU discharge)
  • Change of heart rate variability(The 1st and 3rd days of ICU recruitment)
  • Change from baseline on anxiety(the 1st day of ICU recruitment and up to 30 and 180 days)
  • Change of pain(The 1st day of ICU recruitment, 30 and 180 days days after ICU discharge)
  • Electroencephalography(The 1st day to 3rd day of ICU recruitment)

研究者

发起方
Hsiao-Yean Chiu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hsiao-Yean Chiu

Associated professor

Taipei Medical University

研究点 (1)

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