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临床试验/NCT07559461
NCT07559461招募中不适用

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

Stony Brook University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Differences in anxiety scale scores pre- and post-operatively in anesthesia-naïve patients

研究概览

简要总结

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.

详细描述

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.

研究设计

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

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

  • 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

排除标准

  • 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

结局指标

主要结局

Differences in anxiety scale scores pre- and post-operatively in anesthesia-naïve patients

时间窗: 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.

次要结局

  • 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.(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.(From enrollment until 7 days (+/-71 hours) post-operative)

研究者

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

Ana Costa

Principle Investigator

Stony Brook University

研究点 (1)

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