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Fear and Anxiety in Anesthesia-Naïve Patients Pre-operatively vs Post-operatively

2026年4月29日 更新者:Ana Costa、Stony Brook University

Fear and Anesthesia: How Anxiety and Fear in Anesthesia-Naïve Patients Changes From Preop to Postop

The goal of this observational study is to understand how fear and anxiety felt by anesthesia-naive patients compares before versus after their scheduled surgery. Patients who are scheduled to undergo a low-risk surgery/procedure and have never had anesthesia before will be asked to:

  1. Fill out a survey before their surgery in the perioperative setting
  2. Answer follow-up questions over the phone a few days after their surgery.

研究概览

地位

招聘中

详细说明

Patients that fit the inclusion/exclusion criteria and consent to the study will fill out a paper survey that is an adapted version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS) along with additional questions related to anesthesia anxiety for secondary analysis. 7 days (+/-72 hours) after the patient's surgery, they will complete a follow-up survey over the phone that is an adapted version of the APAIS. Results will be recorded on paper and then uploaded into REDCap for data analysis.

研究类型

观察性的

注册 (估计的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients over 18 who have never received anesthesia before that are scheduled to undergo a low-risk surgery/procedure at Stony Brook University Hospital, Stony Brook Ambulatory Surgery Center, or Stony Brook Ambulatory Care Pavilion.

描述

Inclusion Criteria:

  • 18 years old or over
  • Patients scheduled to undergo surgeries such as but not limited to:

cholecystectomies, appendectomies, hernia repairs, breast surgeries, plastic surgeries, thyroidectomy, parathyroidectomy, tonsillectomy, adenoidectomy, lithotripsy, stent placement, kidney stone surgeries, cystoscopies, bladder tumors, ovarian cystectomies, hysterectomies, tubal ligation, hysteroscopy, Intrauterine Device (IUD) insertion, knee replacement, hip replacement, fracture pinning, sports injury surgery such as knee and shoulder scopes. OR patients undergoing procedures such as but not limited to: colonoscopies and endoscopies

  • Patient undergoing anesthesia for the first time
  • Patients who are not pregnant by self report

Exclusion Criteria:

  • Patients under 18
  • Patients who are pregnant
  • Patients undergoing high-risk surgeries
  • Patients undergoing cancer-related procedures
  • Non-English speaking patients
  • Patients that experience mental status change postoperatively as determined by the medical teams caring for the patient
  • Patients with an existing anxiety disorder, or psychiatric diagnoses
  • Patients on benzodiazepines, antidepressants, chronic opioids

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Differences in anxiety scale scores pre- and post-operatively in anesthesia-naïve patients
大体时间:From enrollment until 7 days (+/-72 hours) post-operative
Participants will be given 2 scores based on their pre-operative survey and their post-operative survey. The change in anxiety score will be evaluated.
From enrollment until 7 days (+/-72 hours) post-operative

次要结果测量

结果测量
措施说明
大体时间
Determining if there is an association between a pre-operative desire for information related to anesthesia and the post-operative reality of the individual subject's anesthesia experience.
大体时间:From enrollment until 7 days (+/-71 hours) post-operative
This data will be collected from the pre-operative and post-operative survey questionnaires and evaluated for correlation.
From enrollment until 7 days (+/-71 hours) post-operative
Comparing the frequency of specific fears of events pre-operatively versus the post-operative reality of the individual subject's anesthesia experience.
大体时间:From enrollment until 7 days (+/-71 hours) post-operative
This data will be collected from the pre-operative and post-operative survey questionnaires and will be evaluated.
From enrollment until 7 days (+/-71 hours) post-operative

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ana Costa, MD、Stony Brook University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月12日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年4月23日

首先提交符合 QC 标准的

2026年4月23日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年5月5日

上次提交的符合 QC 标准的更新

2026年4月29日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB2024-00359

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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