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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Van、七面鳥
- Van Yüzüncü Yıl University, Dursun Odabaş Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ: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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介入なし: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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anxiety
時間枠: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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協力者と研究者
スポンサー
捜査官
- スタディチェア:Nureddin Yüzkat、Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology a nd Reanimation Department, Van, Turkey
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Group IOREの臨床試験
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