冷水蒸気の適用が吐き気と嘔吐に及ぼす影響
腹腔鏡下腹部手術後の吐き気と嘔吐に対する冷蒸気適用の効果：ランダム化比較試験
The aim of this study was to determine the effect of cold vapour applied to patients undergoing laparoscopic abdominal surgery primarily on nausea and vomiting and secondarily on antiemetic requirement, patient satisfaction and thirst.
H1: Cold steam application after surgical intervention has a decreasing effect on postoperative nausea.
H2: Cold steam application after surgical intervention has a decreasing effect on postoperative vomiting.
H3: Cold steam application after surgical intervention reduces the need for antiemetic drugs.
H4: Cold steam application after surgical intervention has a satisfactory effect on reducing nausea and vomiting.
調査の概要
詳細な説明
The research will be conducted with the participation of surgical patients who underwent laporoscopic abdominal surgery between December 2024 and March 2025 in the General Surgery Department of Trakya University Hospital.
Effect size of 0.2 was predicted, the smallest possible significant correlation coefficient between repeated measurements was accepted as 0.3, and the minimum number of people to be included in the sample was calculated as 80, consisting of 40 patients from each group with a 95% confidence level, 5% margin of error and 80% power value. In case of possible data loss, drop out rate was accepted as 10% and 44 patients were included in each group.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Edirne、トルコ（Türkiye）
- Trakya University Hospital
-
-
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:
- Undergoing abdominal surgery under general anaesthesia,
- Admitted to the general surgery ward after surgery,
- Who volunteered to participate in the research,
- No mental disability,
- 18 years of age,
- Literate,
- Accepting random selection,
- without Turkish communication problems,
- No preoperative oncological treatment,
- undergoing elective surgery,
- Postoperatively without a nasogastric catheter,
- with an operation time <4 hours,
- Laparoscopic surgery performed,
- No postoperative nausea and vomiting or mild/moderate nausea,
- Patients with ASA score 1, 2 or 3 were determined as inclusion criteria.
Exclusion Criteria:
- Severe nausea or active vomiting prior to administration,
- Migraine, vertigo, etc. who may experience nausea and vomiting due to vestibular disease, pregnancy,
- COPD, asthma, etc. with respiratory problems,
- Not accepting the application of cold steam,
- Not accepting random selection,
- Those with a history of chemotherapy or radiotherapy before surgery,
- Patients who underwent sudden movement changes (bed change, patient transfer, etc.) during the data collection period (0 to 2nd hour),
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Experimental group
Patients in the experimental group will receive inhaled cold vapour. |
After the surgery, the patients will be admitted to the ward and taken to the bed, and their care and treatment will be applied by the nurse. Afterwards, the researcher will apply cold vapour as an inhaler for 15 minutes. For this application, the stand to which the ultrasonic nebuliser device is connected will be positioned close to the patient's bed. 200 ml of distilled water will be placed in the liquid reservoir of the device. The patient will be given a comfortable position and the device will be adjusted so that the steam hose covers the patient's mouth and nose and the patient will be allowed to inhale the steam through the mouth and nose. After the electrical connection of the device is provided, the device will be started and cold steam application will begin. In the 1st hour, inhaler cold water vapour application will be performed for 15 minutes. |
|
介入なし：Control group
Patients in the control group will not be intervened within the scope of the study. |
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 |
|---|---|---|
|
nausea rate
時間枠：6 months
|
Nausea rate (%) |
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Antiemetic requirement
時間枠：6 months
|
Antiemetic requirement (Yes/No) |
6 months
|
協力者と研究者
スポンサー
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 (推定)
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。