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临床试验/NCT07619326
NCT07619326已完成不适用

Effects of a Repeated Acupressure Program on Agitation, Pain, and Sleep in Mechanically Ventilated Intensive Care Unit Patients: A Randomized Controlled Trial

Yang Yun Shiuan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月6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
60
试验地点
1

研究概览

简要总结

Mechanically ventilated intensive care unit (ICU) patients commonly experience agitation, pain, and sleep disturbances, which may negatively affect recovery and increase the need for sedative medications. Non-pharmacological interventions such as acupressure have been proposed as potential supportive strategies for symptom management in critically ill patients.

This randomized controlled trial aims to evaluate the effects of a repeated acupressure program on agitation, pain, and sleep in mechanically ventilated ICU patients. Participants will be randomly assigned to either an acupressure intervention group or a control group receiving light touch at the same acupoints. The intervention was administered twice daily for four consecutive days. Agitation, pain, and sleep outcomes will be assessed using both subjective and objective measurements, including wearable device-based monitoring. The study also aims to explore the cumulative effects of repeated acupressure intervention during ICU hospitalization.

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, Care Provider, 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

  • Adult patients aged 20 years or older
  • Admitted to an intensive care unit
  • Receiving mechanical ventilation via an oral endotracheal tube
  • Richmond Agitation-Sedation Scale (RASS) score between +2 and +3
  • Expected to remain in the ICU for at least 4 consecutive days
  • Able to receive acupressure intervention as determined by the clinical care team

排除标准

  • planned extubation or ventilator weaning during the study period to ensure a stable clinical condition throughout the intervention period
  • requirement for deep sedation (e.g., continuous high-dose midazolam or propofol)
  • severely hemodynamic or respiratory instability (e.g., APACHE II ≥30, heart rate ≥150 beats/min with severe arrhythmia, respiratory rate ≥30 breaths/min, SpO₂ <90%, or use of high-dose vasopressors with mean arterial pressure ≤50 mmHg)
  • severe agitation requiring immediate pharmacological restraint
  • diagnosed delirium, psychiatric disorders, or neurocognitive disorders
  • bleeding tendency (e.g., platelet count <20,000/µL) or contraindications to acupressure

研究者

发起方
Yang Yun Shiuan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yang Yun Shiuan

Clinical Nurse

Changhua Christian Hospital

研究点 (1)

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