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临床试验/NCT07117578
NCT07117578已完成不适用

Assessment of Preoperative Anxiety in Adult Patient Undergoing Elective Surgery in Eastem Sub-urban Area ofNepa

Tribhuvan University Teaching Hospital, Institute Of Medicine.1 个研究点 分布在 1 个国家目标入组 422 人开始时间: 2025年3月19日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
422
试验地点
1
主要终点
Preoperative Anxiety Prevalence

研究概览

简要总结

This study is looking at how many adults feel nervous or worried before planned surgery at two hospitals in eastern Nepal. We will include men and women aged 18 to 80 who are having elective operations.

On the day of the preoperative check, the participant will be asked to complete a very short, six-question survey about how anxious the participant feels and how much information the participant wants. It takes about five minutes, and the participant can answer by choosing responses like "not at all," "somewhat," or "extremely."

The investigating anesthesiologist will also make a quick, private note of how anxious they think you are based on their routine pre-anaesthesia check. All of the participant answers and the doctor's note will be kept strictly confidential and stored securely.

Joining the study is entirely voluntary. Deciding not to take part or choosing to leave the study at any time will not change the medical care you receive. There are no extra costs or medical tests beyond what you would normally have.

By sharing your experience, the participant helps us understand what makes patients feel anxious before surgery and how the investigators can improve support and information for future patients.

详细描述

This is a cross-sectional observational study conducted at Bhadrapur Provincial Hospital and Om Sai Pathibhara Hospital. We aim to enrol 422 adult patients (18-80 years old) with ASA physical status I to III scheduled for elective surgery.

The investigator will use the Amsterdam Preoperative Anxiety and Information Scale (APAIS) to measure patient-reported anxiety and information need. This six-item tool yields an anxiety score (4-20 points) and an information-need score (2-10 points). A score of 11 or more indicates high anxiety. In addition, the attending anesthesiologist will rate each patient's anxiety immediately after the pre-anaesthetic check.

We will collect demographic and clinical data, including age, gender, marital status, education level, occupation, previous anaesthesia exposure, type of anaesthesia, and area of residence. Data entry will be done in Excel, and analysis will be carried out using SPSS. We will report median and interquartile ranges for APAIS scores and use multivariable logistic regression to identify factors associated with high anxiety.

The study protocol has been approved by the Nepal Health Research Council. Participant confidentiality will be maintained through coded identifiers, locked physical records, and encrypted digital files.

The investigator's goal is to determine how common preoperative anxiety is and which patient characteristics influence it. The findings will guide the development of targeted interventions and information programmes to reduce anxiety before surgery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • Adults aged 18-80 years
  • Scheduled for elective surgery with prior pre-anesthetic clearance
  • Able to provide informed consent

排除标准

  • Decline to participate
  • Documented psychiatric disorders or cognitive impairment
  • Current treatment with anxiolytics or antidepressants
  • Language barrier preventing questionnaire completion
  • ASA Physical Status IV or higher

结局指标

主要结局

Preoperative Anxiety Prevalence

时间窗: Single preoperative assessment before surgery

Assessment Tool: Amsterdam Preoperative Anxiety and Information Scale (APAIS) to measure patient-reported anxiety and information need. This six-item tool yields an anxiety score (4-20 points) and an information-need score (2-10 points). Definition: Amsterdam Preoperative Anxiety and Information Scale, total anxiety score ≥11,

次要结局

  • Clinician Anxiety Rating Score vs. Amsterdam Preoperative Anxiety and Information Scale(Single preoperative assessment before surgery)
  • Anxiety Associations with Demographic & Clinical Factors(Single preoperative assessment before Surgery)

研究者

发起方
Tribhuvan University Teaching Hospital, Institute Of Medicine.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sujan Dhakal, MD

Consultant Anesthesiologist

Tribhuvan University Teaching Hospital, Institute Of Medicine.

研究点 (1)

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