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临床试验/NCT06329934
NCT06329934已完成不适用

Effect of Refined Nursing in Rehabilitation Training for Patients With Brain Injury During the Recovery Period: An Observational Study

Xinxiang Central Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2022年5月1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
96
试验地点
1
主要终点
incidence of adverse reactions

研究概览

简要总结

This study is to explore the clinical effect of refined nursing in rehabilitation training for patients with brain injury during the recovery period. Patients in the control group were provided with routine nursing intervention, while patients in the study group adopted a nursing mode based on the concept of refinement treatment. Comparison was made in terms of the Glasgow Coma Scale (GCS) score, cognitive function score, functional independence score, nursing satisfaction, and incidence of complications.

详细描述

This study is to explore the clinical effect of refined nursing in rehabilitation training for patients with brain injury during the recovery period. The subjects of the study were 96 patients with severe traumatic brain injury (TBI). According to the order of visits, there were 48 patients in the study group and the control group, respectively.Patients in the control group were provided with routine nursing intervention, while patients in the study group adopted a nursing mode based on the concept of refinement treatment. Comparison was made in terms of the Glasgow Coma Scale (GCS) score, cognitive function score, functional independence score, nursing satisfaction, and incidence of complications.

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 (Participant)

入排标准

年龄范围
33 Years 至 43 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients diagnosed with severe TBI through imaging examinations such as head CT and magnetic resonance imaging
  • patients with surgical indications
  • patients with Glasgow Coma Scale (GCS) ≤8 points
  • patients with complete clinical data
  • patients with written informed consent provided by family members

排除标准

  • patients with organic lesions of major organs such as liver and kidney
  • patients with contraindications for surgery
  • patients with primary diseases such as cerebral hemorrhage and cerebral infarction
  • patients with combined or multiple injuries
  • patients with respiratory failure
  • patients whose family members had cognitive impairment or abnormal mental behaviors

结局指标

主要结局

incidence of adverse reactions

时间窗: 2 months after rehabilitation treatment

Incidence (%)=Number of patients with complications/48×100%

GCS scores

时间窗: 2 months after rehabilitation treatment

The highest GCS score was 15 points, indicating clear consciousness; while patients with 13-15, 9-12, and ≤8 points were classified as mild, moderate consciousness disorder, and coma, respectively. Patients with lower scores might indicate more serious consciousness disorder

functional independence scores

时间窗: 2 months after rehabilitation treatment

Functional Independence Measure (FIM), utilizing a 7-point ordinal scale, was employed to assess the functional independence of two groups of patients before and 2 months after rehabilitation treatment. FIM measures independent performance in self-care, sphincter control, mobility, locomotion, communication, social cognition, etc. The minimum score is 18 points, and the maximum score is 126 points (91 points for motor function and 35 points for cognitive function)

Newcastle Satisfaction with Nursing Scale (NSNS)

时间窗: 2 months after rehabilitation treatment

The Newcastle Satisfaction with Nursing Scale (NSNS) was used to survey patient's nursing satisfaction. This scale measures patient's satisfaction with nursing care from 19 items, including nurse work ability, communication attitude, psychological counseling, nursing support, safety management, etc. It uses a 1-5 point scoring system, with a maximum possible score of 19-95 points. A score of ≥77, 58\~76, 39\~57 and ≤38 points indicated very satisfied, satisfied, somewhat satisfied, and dissatisfied, respectively. Satisfaction rate= (Cases of very satisfied + satisfied + somewhat satisfied)÷total cases

cognitive function scores

时间窗: 2 months after rehabilitation treatment

Cognitive function was evaluated using the Chinese version of the Neurobehavioral Cognitive Status Exam (NCSE) to assess the cognitive function of patients before and 2 months after rehabilitation treatment. This scale includes 10 items, i.e., spatial orientation (12 points), concentration (8 points), understandability (6 points), retelling (12 points), naming (8 points), spatial construction (6 points), memory (12 points), computing (4 points), similarity (8 points), and judgment (6 points)

次要结局

未报告次要终点

研究者

发起方
Xinxiang Central Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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