- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03711201
Effects of Preoperative Operating Room Environment Presentation in Hypertensive Patients
The Effects of the Preoperative Operating Room Environment Presentation on Preanesthetic Anxiety and Blood Pressure in Hypertensive Patients: A Prospective, Randomized Controlled Trial
연구 개요
상세 설명
Procedure to be Applied:
In order to eliminate the other factors that cause essential HT, the patients' blood pressure due to HT should be controlled, the surgery will be planned as the first case in the morning and the patients will need 8 hours fasting period.
Patients' gender, age, height, weight values, ASA scores, body mass index (BMI) values will be recorded. Hemodynamic parameters (blood pressure, heart rate and SpO2 values) will be recorded in the services of the patients, in the preop unit and in the operation room. Hypertension requiring intervention or additional medication will be excluded from the study. A randomized number of patients will be included in the study according to the results of power analysis.
Introduction of the operating room environment (IORE): The procedure to be performed on the day of surgery will be simulated and accompanied by an anesthesiologist. The patient's hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured at the time of operation, between 16: 00-18: 00 hours prior to the operation, and will be brought to the operating room with a service nurse. The hemodynamic data of the patient will be measured in the preop unit and the patient will be taken to the operating room with anesthesia doctor. Here, in addition to the patient's hemodynamic data, the instantaneous state anxiety scale (ST-STAI) will be completed and the patient will be left in service again. The procedure will be similar to the process that the patient will experience on the operation day.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Van, 칠면조
- Van Yüzüncü Yıl University, Dursun Odabaş Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- elective surgery
- informed consent,
- essential hypertension was diagnosed,
- Between the ages of 40-80,
- American Society of Anesthesiologists (ASA) class II-III
Exclusion Criteria:
- drug allergy,
- with a history of malignant hyperthermia,
- uncontrolled hypertension,
- cancer and psychological problems,
- patients with cardiac and endocrine diseases
- emergency surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Group IORE
This group will undergo the IORE procedure before surgery (operation).
On the day of surgery, the patient will be brought to the operating room by the anesthesiologist.
Hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured at the service, preop unit and operating room.
The anxiety level in the operating room will be measured by the ST-STAI scale.
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This group will undergo the IORE procedure before surgery (operation).
On the day of surgery, the patient will be brought to the operating room by the anesthesiologist.
Hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured at the service, preop unit and operating room.
The anxiety level in the operating room will be measured by the ST-STAI scale.
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간섭 없음: Group NoIORE
The patient's hemodynamic data will be measured in the evening service before surgery.
The patient will be brought to the operating room by the anesthesiologist on the day of surgery and hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured in the preop unit.
The hemodynamic data and the ST-STAI scale will measure the anxiety level in the operating room.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
anxiety
기간: 1 day
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The patient's anxiety will be measured by instantaneous state anxiety scale (ST-STAI)
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1 day
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공동 작업자 및 조사자
수사관
- 연구 의자: Nureddin Yüzkat, Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology a nd Reanimation Department, Van, Turkey
간행물 및 유용한 링크
일반 간행물
- Kakinuma A, Nagatani H, Otake H, Mizuno J, Nakata Y. The effects of short interactive animation video information on preanesthetic anxiety, knowledge, and interview time: a randomized controlled trial. Anesth Analg. 2011 Jun;112(6):1314-8. doi: 10.1213/ANE.0b013e31820f8c18. Epub 2011 Feb 23.
- 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.
- Paterniti S, Alperovitch A, Ducimetiere P, Dealberto MJ, Lepine JP, Bisserbe JC. Anxiety but not depression is associated with elevated blood pressure in a community group of French elderly. Psychosom Med. 1999 Jan-Feb;61(1):77-83. doi: 10.1097/00006842-199901000-00013.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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