- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07559461
Fear and Anxiety in Anesthesia-Naïve Patients Pre-operatively vs Post-operatively
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:
- Fill out a survey before their surgery in the perioperative setting
- Answer follow-up questions over the phone a few days after their surgery.
연구 개요
상세 설명
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Anna Suske
- 전화번호: 631-638-1214
- 이메일: anna.suske@stonybrookmedicine.edu
연구 장소
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New York
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Stony Brook, New York, 미국, 11794
- 모병
- Stony Brook University Hospital
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연락하다:
- Anna Suske
- 전화번호: 631-638-1214
- 이메일: anna.suske@stonybrookmedicine.edu
-
연락하다:
- Ana Costa, MD
- 전화번호: 631-358-6513
- 이메일: ana.costa@stonybrookmedicine.edu
-
수석 연구원:
- Ana Costa, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Differences in anxiety scale scores pre- and post-operatively in anesthesia-naïve patients
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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.
기간: From enrollment until 7 days (+/-71 hours) post-operative
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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
|
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Comparing the frequency of specific fears of events pre-operatively versus the post-operative reality of the individual subject's anesthesia experience.
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ana Costa, MD, Stony Brook University
간행물 및 유용한 링크
일반 간행물
- Celik F, Edipoglu IS. Evaluation of preoperative anxiety and fear of anesthesia using APAIS score. Eur J Med Res. 2018 Sep 11;23(1):41. doi: 10.1186/s40001-018-0339-4.
- Mavridou P, Dimitriou V, Manataki A, Arnaoutoglou E, Papadopoulos G. Patient's anxiety and fear of anesthesia: effect of gender, age, education, and previous experience of anesthesia. A survey of 400 patients. J Anesth. 2013 Feb;27(1):104-8. doi: 10.1007/s00540-012-1460-0. Epub 2012 Aug 3.
- Shafer A, Fish MP, Gregg KM, Seavello J, Kosek P. Preoperative anxiety and fear: a comparison of assessments by patients and anesthesia and surgery residents. Anesth Analg. 1996 Dec;83(6):1285-91. doi: 10.1097/00000539-199612000-00027.
- Eberhart L, Aust H, Schuster M, Sturm T, Gehling M, Euteneuer F, Rusch D. Preoperative anxiety in adults - a cross-sectional study on specific fears and risk factors. BMC Psychiatry. 2020 Mar 30;20(1):140. doi: 10.1186/s12888-020-02552-w.
- Dost B, Komurcu O, Bilgin S, Turunc E, Ozden GG, Hancioglu S, Baris S. Is Preoperative Anxiety Affected by Watching Short Videos on Social Media? A Prospective Randomized Study. J Perianesth Nurs. 2023 Oct;38(5):758-762. doi: 10.1016/j.jopan.2023.01.006. Epub 2023 Feb 16.
- Tatli U, Kalkan T. Does Social Media Increase Perioperative Anxiety in Patients Undergoing Impacted Third Molar Surgery? J Oral Maxillofac Surg. 2025 Mar;83(3):344-352. doi: 10.1016/j.joms.2024.11.010. Epub 2024 Nov 22.
- Heyman B, Wigzell H. Immunoregulation by monoclonal sheep erythrocyte-specific IgG antibodies: suppression is correlated to level of antigen binding and not to isotype. J Immunol. 1984 Mar;132(3):1136-43.
- Kilinc M, Ozer AB. Fear of going under general anesthesia: A cross-sectional study. Saudi J Anaesth. 2017 Jan-Mar;11(1):128-129. doi: 10.4103/1658-354X.197361. No abstract available.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- IRB2024-00359
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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