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临床试验/NCT03581097
NCT03581097已完成不适用

The Effect of Informational Videos on Preoperative Anxiety and Satisfaction Levels in Patients Undergoing Elective Ambulatory Surgery. A Case-control Clinical Trial

University Hospital, Geneva2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
2
主要终点
VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale)

研究概览

简要总结

Preoperative anxiety is a common problem with an impact on surgical outcome, anaesthetic drug dosage and patient's satisfaction. An important component of preoperative anxiety is due to concerns related to anaesthesia. Appropriate patients information has been shown to reduce preoperative anxiety level and this can be effectively achieved through a video. The aim of this study is to assess the impact of an informative video about the anaesthesia technique on patient's preoperative anxiety levels before minor ambulatory procedures.

The study design is a prospective, randomized, controlled clinical trial, where we use of short patient educational video to reduce preoperative anxiety level, explaining all sequence of major events between the arrival in the operating room and the performance of anaesthesia.

详细描述

Anxiety is a common problem in patients undergoing invasive procedures, arriving in some studies up to 60-80%. Perioperative anxiety is correlated with hemodynamic effects (such as arterial hypertension and arrhythmias), it can have an impact on final surgical outcome, on anaesthetics drug dosage, and also with an growth about the perception of post-operative pain, leading to a substantial increase in analgesics dose and the number of post-operative hospitalization days. Finally, perioperative anxiety can reduce the patient's overall satisfaction with the quality of perioperative care.

Patients' satisfaction is largely based on their expectations and it forms part of the surgeon's reward: satisfied patients are more likely to maintain a good relationship with the surgeon, abstain from so called "doctor shopping", avoid malpractice litigations and recommend their surgeon to others. Last but not least, satisfied patients are more likely to comply with postoperative prescriptions and attend follow-up appointments. In non-life threatening procedures however, the main source of preoperative anxiety is often the outlook of anaesthesia rather than surgery itself, this being mainly related to a lack of enough information about the anaesthetic procedure. These fears are largely underestimated in routine minor procedures (such as ambulatory surgery) and thus risk to be not properly addressed. Due to lack of time and resources, this could have a significant impact on global patient satisfaction. Also if major complications (e.g. cardiac mortality) are surgery-related, anxiety is also associated with poor surgical outcome. How to identify and treat patients who will likely benefit from more information about anaesthesia is an important question that remains relatively unaddressed. However, it's known that more information about surgery reduces the level of anxiety and apprehension.

Some strategies have been developed to try to reduce pre-operative stress: deliver clinical information has proven to be able to relieve patient anxiety. Written information has recognised useful, but not all patients have shown the same degree of culture needed to read and understand texts. The use of multimedia information (such as videos) has already been studied and some trials have shown a certain anxiolytic effect, but data are conflicting. A part of this disparity probably derives from differences in methodology and culture between patients.

For these reasons the investigators developed a trial using a short educational video about the global management of local anaesthesia on outpatient hand surgery. The aim of this study is to assess the impact of this educational video about perioperative patient's anxiety levels.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Surgeon and investigators involved in subsequent data analysis were blinded to group assignment

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

  • patients older than 18 years,
  • American Society Anesthesiology (ASA) score I-III patients
  • patients undergoing elective hand-surgery operation
  • patients anesthetized by IntraVenous Regional Anesthesia (IVRA)

排除标准

  • patient refusal,
  • on-going anxiolytic or anti-depressive therapy,
  • diagnosis of anxiety or psychiatric disorders,
  • general contraindications to IVRA,
  • limited compliance
  • language barriers

研究组 & 干预措施

Video Group

Experimental

Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of intravenous regional anesthesia

干预措施: Video Group (Other)

Control Group

No Intervention

Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.

结局指标

主要结局

VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale)

时间窗: 2 hours

Primary outcome measure is to see and analyze any difference in preoperative anxiety between the video and control group, measured on our Adapted Visual Analogue Scale (VAS-A). Scale range is 0 to 5, where 0 means no anxiety, while 5 means maximal anxiety. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of regional anesthesia.

次要结局

  • Degree of Satisfaction(3 hours)
  • Vital Parameters 1: Arterial Blood Pressure(2 hours)
  • Vital Parameters 2: Respiratory Rate(2 hours)
  • Vital Parameters 3: Heart Rate(2 hours)
  • First Subgroups Analyze: Anxious Patients(2 hours)
  • Second Subgroups Analyze: Higher Anxiety Score(2 hours)
  • Third Subgroup Analyze: First Experience With Surgery.(2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samuele Ceruti

Dr. med.

University Hospital, Geneva

研究点 (2)

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