跳至主要内容
临床试验/NCT04188795
NCT04188795已完成不适用

Evaluation of the Effectiveness of Delirium Preventive Care Protocol for Hip Fracture Patients

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年5月25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
80
试验地点
4
主要终点
Richards-Campbell Sleep Questionnaire (RCSQ)

研究概览

简要总结

The prospective, randomized controlled experimental trial investigates the effectiveness of delirium preventive care protocol for hip fracture patients.

详细描述

The aim of this prospective, randomized controlled experimental trial is to evaluate the effectiveness of delirium preventive care protocol on pain, functional status, sleep quality and delirium prevention in patients with hip fracture.

This research was conducted at a training and research hospital's orthopedics and traumatology department. The study sample was compromised of 80 patients with hip fracture. Intervention and control groups were applied after block randomization. Study data was collected by using Patient Information Form, Mini-Cog Test, Confusion Assessment Method, Visual Analogue Scale, Barthel Index, Mini Nutritional Assessment-Short Form and Richards Campbell Sleep Questionnaire. The patients in the intervention group were provided with nursing care in accordance with the delirium preventive care protocol developed with the support of literature. In the control group, routine nursing care was provided in line with the clinical procedure. The data was analyzed by using number, percentage, mean, standard deviation, median, Interquartile Range, Student's t test, Mann-Whitney U test, Pearson's chi square test, Fisher corrected chi-square test, ANOVA test, Paired Sample t test, Friedman test, Wilcoxon test and Cronbach α coefficient.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Planned surgery for hip fracture,
  • 65 years and older,
  • No communication problems in Turkish,
  • Without cognitive impairment,
  • Patients who volunteered to participate in the study

排除标准

  • Patients who could not be evaluated by the investigator before the operation
  • Patients with dementia and Mini-Cog test less than 3 points
  • Patients with a history of cerebrovascular accident
  • Patients with severe comorbidity

结局指标

主要结局

Richards-Campbell Sleep Questionnaire (RCSQ)

时间窗: 4 minutes.

It was applied to patients at first admission to the clinic, on the first and third postoperative day. The scale developed by Richards in 1987; It consists of six items that assess the depth of night's sleep, the time to fall asleep, the frequency of waking up, the time to wake up, the quality of sleep and the noise level in the environment. Each item is evaluated on the chart from 0 to 100. A score of 0-25 indicates a very poor sleep and a score of '76 -100 indicates a very good sleep. The higher the scale score, the better the sleep quality of the patients. The total sleep score is calculated by taking the average of the depth of sleep, the time to fall asleep, the frequency of waking up, the time to stay awake and the quality of sleep.

Visual Analog Scale (VAS)

时间窗: 1 minute.

It was applied to patients at first admission to the clinic, on the first and third postoperative day. It is used to measure the severity of pain. It is easy to use and the same in every language. At the two ends of a ten-centimeter line, two end definitions of the parameter to be evaluated are written and the patient is asked to indicate where his or her condition is appropriate by drawing a line or by pointing or pointing (0: I have no pain, 10: I have unbearable pain). The length of the distance from the absence of pain to the location of the patient indicates the pain of the patient. Less than three of this numerical expression indicates mild pain, three to seven indicates moderate pain, and more than seven indicates severe pain.

Mini Nutritional Assesment- Short Form (MNA-SF)

时间窗: 2 minutes.

It was applied to patients at first admission to the clinic for evaluating of malnutrition. Its use in the elderly is recommended by the European Society for Clinical Nutrition and Metabolism (ESPEN). According to the screening score; 0-7 points indicate malnutrition, 8-11 points indicate malnutrition risk, 12-14 points indicate normal nutritional status.

Barthel Index (BI)

时间窗: 5 minutes.

Patients filled at frst admission to the clinic, on the first and third postoperative day was developed in 1965 by Mahoney and Barthel. It is used to determine the level of independence of individuals in their activities. The Barthel Index measures the social and physical function of daily life and consists of 10 items that assess the individual's ability to meet daily functions (nutrition, bathing, personal care, dressing, toileting, mobility on flat surfaces, transfer, climbing stairs, bowel and bladder function) without assistance. Each item is scored between 0-15 (varies according to the question). Barthel Index total scores vary between 0-100; 0-20 points completely addiction; 21-61 points severe addiction; Moderate dependence of 62-90 points; 91-99 points mild addiction; 100 points explain independence. In the studies using the Barthel Index, 60 points were taken as the limit and scores above 60 explain the ability to function independently.

次要结局

未报告次要终点

研究者

发起方
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
申办方类型
Other
责任方
Sponsor

研究点 (4)

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