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临床试验/NCT07309458
NCT07309458已完成不适用

Effectiveness of a Nursing Intervention on Pre-surgical Anxiety

University of Valencia1 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2024年5月2日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
314
试验地点
1
主要终点
Change in Anxiety Severity assessed by the Hamilton Anxiety Rating Scale (HAM-A)

研究概览

简要总结

Preoperative anxiety is a very common experience among surgical patients. Many people scheduled for Day Surgery (Ambulatory Major Surgery, AMS) experience worry, tension, or fear while waiting to enter the operating room. This anxiety is not incidental; numerous studies have shown that it can influence pain perception, postoperative recovery, and overall satisfaction with the surgical procedure. Despite its relevance, routine clinical practice does not always include structured interventions to help patients manage these feelings in the moments immediately before surgery. Due to their close and continuous role throughout the surgical process, nursing professionals are key in providing this type of support.

This clinical study is being conducted at Hospital de la Malvarrosa (Valencia) and focuses on adult patients scheduled for AMS across different surgical specialties, including Otorhinolaryngology, Maxillofacial Surgery, General Surgery, and Urological Surgery. Its aim is to provide a clear, evidence-based answer to the following question: can an individualized nursing intervention applied in the immediate preoperative period reduce anxiety levels and improve the patient's overall surgical experience? The study hypothesis proposes that a brief, personalized intervention delivered by nursing staff-based on empathic communication, tailored information, and simple coping techniques-can help patients manage preoperative anxiety and positively influence their perception of the surgical process.

To test this hypothesis, the study compares two groups of patients undergoing AMS. The control group receives standard preoperative care, which includes clinical preparation and the basic information routinely provided before surgery. The intervention group, in contrast, receives an additional individualized nursing intervention lasting approximately 15-20 minutes in the preoperative area, carried out alongside routine preparation procedures such as intravenous cannulation, medication administration, or surgical checklist verification. During this process, the nurse creates a trusting environment, encourages patients to express their fears, validates their emotions, provides clear and understandable explanations of the different stages of the procedure, and teaches simple breathing and emotional regulation techniques.

Anxiety levels are assessed using a validated clinical scale that measures both physical and emotional symptoms related to anxiety. Assessment takes place in the immediate preoperative period, allowing for an objective comparison between the control and intervention groups. In addition, the study collects data on personal, social, and surgical variables that may influence anxiety, with the aim of better understanding which patient profiles are more vulnerable and which benefit most from the intervention.

Although the primary approach of the study is quantitative, a qualitative perspective is also incorporated to explore the subjective experiences of both patients and nursing staff.

Overall, this study aims to demonstrate that a humanized, structured, and evidence-based nursing intervention can significantly reduce preoperative anxiety in AMS and improve the surgical experience. Furthermore, it seeks to contribute knowledge that supports the development of more comprehensive care protocols in which patients' emotional well-being is considered an essential component of surgical preparation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Patients over 18 years old.
  • Voluntary participation and informed consent to participate in the study.
  • Individuals scheduled for major outpatient surgical procedures in operating rooms 5 and 6 of La Malvarrosa Hospital

排除标准

  • Patients with comprehension difficulties (hearing loss, language barrier, or insufficient cognitive level).
  • Patients with temporarily impaired cognitive ability (premedicated with benzodiazepines)
  • Clinical situations that prevented participation in data collection.

结局指标

主要结局

Change in Anxiety Severity assessed by the Hamilton Anxiety Rating Scale (HAM-A)

时间窗: Baseline (upon a arrival at holding area) and inmediatly post nursing intervention (approximately 20 minutes after baseline)

The HAM-A consists of 14 items that measure both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (very severe). The total score ranges from 0 to 56, obtained by summing the scores of all 14 items. Higher scores indicate higher levels of anxiety (worse outcome). Scores are interpreted as follows: 0-17 (mild anxiety), 18-24 (moderate anxiety), 25-30 (severe anxiety), and \>30 (very severe anxiety).

次要结局

未报告次要终点

研究者

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

Elena Violeta Iborra Palau

Principal Investigator

University of Valencia

研究点 (1)

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