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临床试验/NCT07313163
NCT07313163尚未招募不适用

Evaluation of the Effect of Music During Nursing Care on the Confort of Patient Hospitalized in Intensive Care Unit During the Acute Phase of a Stroke

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
102
试验地点
1
主要终点
Auto _ Evaluation of patient confort during nursing care

研究概览

简要总结

Nurses in Stroke Units and Neurovascular Intensive Care Units (USINV) provide care for patients who have experienced a stroke, a sudden and often devastating event that can result in motor, sensory, visual, cognitive, language, or swallowing impairments. Despite advances in stroke management, it remains the leading cause of acquired disability and the second leading cause of death in France, with 122,422 hospitalizations in 2022 and 773 at our institution in 2023. Acute stroke care guidelines recommend hospitalization in specialized neurovascular intensive care units (USINV), as this setting improves survival and recovery through specialized nursing care, close monitoring, and prevention of complications. However, the sudden onset of disability and the unfamiliar, often stressful hospital environment can lead to anxiety, fear, and a sense of helplessness among patients.

Providing comfort is a key nursing objective in this context. Kolcaba defines comfort as the experience of having fundamental needs for relief, well-being, and transcendence met in physical, psycho-spiritual, environmental, and sociocultural dimensions. Hygiene care, in particular, can contribute to comfort by ensuring cleanliness, minimizing pain, and improving self-image. The use of music during care has been proposed as a means to enhance comfort by positively influencing both physical and psychological states, as well as the care environment. Music can stimulate the senses, redirect attention, evoke pleasant memories, reduce stress, and provide a sense of control and identity for patients.

While music therapy-a specialized practice requiring trained professionals-has been studied in various fields, the use of music during routine care is distinct and has shown benefits in psychiatry, palliative care, and geriatrics, as well as during stressful procedures. In stroke rehabilitation, music has been explored for its effects on mood and recovery, but its use during the acute phase of stroke in USINV has not been systematically studied. An informal survey at our institution revealed that 78% of nurses and nursing assistants use music during care, particularly during hygiene procedures.

Our hypothesis is that incorporating music into hygiene care can improve patient comfort by addressing physical, psychological, and environmental needs. To assess comfort in a population that may have communication difficulties, we developed a visual comfort scale (0-5) using artificial intelligence-generated facial expressions. This scale was tested on 30 USINV patients and found to be accessible and easy to use, except for those with cognitive impairments or language barriers, who will be excluded from further study.

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
None

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

  • French-speaking patient
  • Aged 18 years or older
  • Diagnosed with a stroke
  • Hospitalized in a Neurovascular Intensive Care Unit (USINV)
  • Requiring a complete bed bath by a nurse or nursing assistant
  • Affiliated with a health insurance scheme
  • Having provided free, informed, and explicit consent

排除标准

  • Patient hospitalized for a reason other than stroke
  • Patient with comprehension disorders (aphasia with impaired comprehension, cognitive disorders predating the stroke, confusion, non-French-speaking)
  • Blind patient
  • Patient under guardianship or curatorship
  • Patient deprived of liberty or under legal protection (sauvegarde de justice)

结局指标

主要结局

Auto _ Evaluation of patient confort during nursing care

时间窗: Day 1

After the nursing care, Patient will evaluate their confort using a visual confort scale with 5 faces showing extreme discomfort (coded 1) to full confort (coded 5)

次要结局

  • Hetero evaluation of patient pain(day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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