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临床试验/NCT05134207
NCT05134207已完成不适用

The Effect of Oral Carbohydrate Solution Given Before Hip Artroplasty on Preoperative Anxiety and Postoperative Patient Comfort

Nevsehir Haci Bektas Veli University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年9月11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
50
试验地点
2
主要终点
preoperative anxiety

研究概览

简要总结

Surgical interventions are not only a physiological trauma, but also a psychological and social trauma because they cause deterioration of the individual's comfort. Comfort is among the most basic human needs and provides a better care output. One of the conditions that cause deterioration of comfort and anxiety in patients is hunger and thirst before surgery. Since 1994, several guides published by professional groups in many countries on pre-operative fasting periods have published that clear liquids can be taken up to 2 hours before the surgery in elective surgeries, and solid foods can be taken up to 6 hours before the surgery. One of the basic principles of ERAS protocols, which include evidence-based care interventions applied at all stages of the surgical process, for the preoperative period is to ensure that the patient takes a carbohydrate drink up to two hours before anesthesia and to shorten the long fasting period. In many countries, the problems experienced by patients as a result of long-term hunger have been identified. When the comfort status of the patients who were given carbohydrate-rich drinks before the surgery was examined, it was observed that the symptoms such as thirst, hunger, insufficiency, fatigue, nausea, pain, anxiety and depression were reduced and oral carbohydrate solutions were recommended. In the literature, it is stated that the prolongation of the fasting period causes an increase in the anxiety of the person and negatively affects his comfort, and it is recommended to drink 800 ml of carbohydrate liquid food until midnight the day before the surgery and 400 ml of liquid carbohydrate food 2-3 hours before the surgery in order to provide metabolic satiety. The nurse, who is one of the health workers responsible for the care of the patient, has to manage the restriction of oral food and liquid intake and the comfort of the patient in the best way before the operation. Accordingly, in our study, the answers were sought whether the oral carbohydrate solution given before hip arthroplasty had an effect on anxiety and patient comfort.

详细描述

Hip arthroplasty (HA) is a very common treatment method in orthopedic surgery worldwide. HA is considered a successful, safe and cost-effective medical intervention to regain pain-free mobility and functionality of the hip joint in patients with severe joint disease or trauma.

It is stated that the annual number of patients undergoing HA in the United States is 193,000, and this number is approximately one million worldwide. In the next 15 years, it is estimated that the number of patients undergoing HA will continue to increase in the world and in Turkey.

It is stated that health care services should start in the preoperative period and continue in the postoperative period, especially in HA surgeries performed due to limitation of mobility. Because HA application is seen as a major surgical intervention and as with many surgical interventions, it can affect the individual as a whole.

Surgical intervention is a combination of anesthesia, drug therapy, tissue trauma, blood loss and body temperature changes. These developing events stimulate metabolic changes and cause postoperative anxiety and stress response at the same time. Exposure of the human body to surgery or other trauma elicits a neurohumoral response and activates a catabolic process. Surgical stress causes an increase in the release of regulatory hormones such as catecholamine, glucagon and cortisol in the body and a decrease in insulin sensitivity. The increase in cortisol level leads to the development of insulin resistance and hyperglycemia, which have an important effect on the healing process. Changes in this process increase the risk of postoperative complications and mortality.

On the other hand, fasting the patient overnight as a standard practice in the preoperative period in order to reduce the risk of lung aspiration in elective surgery patients may cause a change in the insulin glucagon ratio. This increases the stress response to surgical trauma and may have a major impact on glycemic control and insulin resistance. Prolongation of the preoperative fasting period may cause negative effects such as feeling of hunger, anxiety, restlessness, headache, dehydration, hypovolemia and hypoglycemia. However, the increase in the preoperative fasting period causes a decrease in patient satisfaction, and causes undesirable conditions such as nausea and vomiting in the postoperative period, delaying the healing process and prolonging the hospital stay of the patients.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Who volunteered to participate in the research,
  • Total hip replacement surgery planned,
  • Who are over 18 years old,
  • ASA I and II group,
  • First time hip replacement surgery

排除标准

  • Diabetes mellitus,
  • In the emergency patient group,
  • with gastroesophageal reflux,
  • Those with esophageal disease (Hiatus hernia, esophagitis, achalasia...)
  • Having endocrine problem,
  • Diagnosed with ileus,
  • With pyloric stenosis,
  • ASA III and IV group,
  • Intravenous fluid administered before surgery,
  • Using drugs that affect blood glucose levels,
  • Previous hip replacement surgery
  • Body mass index over 35kg/m2 (The value obtained by dividing the weight in kilograms by the square of the height in meters),
  • Having a psychiatric and neurological diagnosis, poor general condition,
  • Needing all kinds of fluid and blood support in the pre-operative period,
  • Patients who use alcohol or cigarettes

结局指标

主要结局

preoperative anxiety

时间窗: just before the patient is sent for surgery

State-Trait Anxiety Scale (The lowest score to be taken from the scale is 20, and the State-Trait Anxiety Scale (The lowest score to be taken from the scale is 20, and the highest score is 80. High scores indicate high anxiety levels, low scores indicate low

patient comfort

时间窗: Considering that the discharge days of the patients would be different, it was applied on the second day after the operation.

Post Hip Replacement Comfort Scale (The highest average score obtained from the scale is 5 and the lowest average score is 1. A high score indicates high comfort, and a low mean score indicates low comfort.)

次要结局

  • postoperative anxiety(Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively.)
  • postoperative pain(Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively)
  • postoperative sensation of thirst(Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively)
  • postoperative nausea- vomiting(Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively)
  • postoperative sensation of hunger(Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively)
  • physiological parameter(postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour)

研究者

发起方
Nevsehir Haci Bektas Veli University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülden Küçükakça Çelik

assistant professor

Nevsehir Haci Bektas Veli University

研究点 (2)

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