The Effects of Menthol and Cold Spray Applications on Thirst and Comfort in Bariatric Surgery
2026年7月22日 更新者：Cagla Toprak、Atlas University
The Effect of Menthol Spray and Cold Spray Applications on Postoperative Thirst Level and Comfort in Patients Undergoing Bariatric Surgery
Bariatric surgery is a widely used surgical treatment method in obesity management that improves quality of life and provides long-term weight loss.
Patients often experience thirst in the early postoperative period.
Factors that increase thirst include cessation of oral intake, room temperature, intubation, dehydration, hypovolemia, and oxygen therapy in the preoperative period.
Furthermore, failure to initiate oral intake early in the postoperative period increases thirst and negatively impacts patient comfort.
The aim of this study is to evaluate the effects of menthol spray and cold spray applications on the thirst and comfort levels of patients in the postoperative period.
The study aims to contribute to the improvement of nursing practices related to postoperative thirst and comfort management with the findings obtained from this study.
This randomized controlled clinical trial is planned to be conducted with patients undergoing bariatric surgery at the General Surgery Clinic of Istanbul Atlas University Hospital.
The study population will consist of patients hospitalized in the General Surgery Department of Atlas University Hospital who have undergone bariatric surgery.
The sample was determined as 159 patients meeting the inclusion criteria in three groups, calculated using the GPower 3.1.9.7 program with an effect size of f=0.25, a significance level of α=0.05, and a test power of (1-β)=0.80.
Considering data loss, the study is planned to be conducted with 180 patients.
The "Patient Information Form," "Visual Analog Scale-Comfort (VAS-A)," "Dehydration Visual Analog Scale (VAS)," and "Surgical Dehydration Discomfort Scale (CDSBRÖ)" will be used to collect research data.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
180
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Istanbul、トルコ（Türkiye）
- Atlas University
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
• Patients who are 18 years of age or older,
- who undergo bariatric surgery under general anesthesia,
- who do not have oral or nasal diseases, or vision, hearing, speech, or comprehension problems,
- who are classified as grade I or II according to the American Society of Anesthesiologists (ASA) Physical Status Classification System,
- who are not allergic to menthol,
- who do not have severe vomiting, and • whose preoperative fasting and thirst period is 8 hours.
Exclusion Criteria:
- Patients with impaired oral and tongue mucosal integrity prior to surgery, Patients with any neurological, kidney, heart or lung disease with cognitive impairment and those using psychoactive drugs will be excluded.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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 |
|---|---|
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プラセボコンパレーター：Plasebo group
Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, and their thirst severity and thirst-related discomfort scale will be assessed.
Initial assessments (irritation, nausea, vomiting, aspiration risk, dysphagia) will be performed as soon as the patient arrives at the clinic post-surgery.
The bed will be raised at a 30°-45° angle to prevent bronchoaspiration.
Before application, air will be removed from the tap and water will be sprayed into the air several times to ensure even distribution.
Then, the patient will be instructed to open their mouth, lift their tongue, and direct the spray towards the sublingual area, the mucous membranes of both cheeks, and the surface of the tongue.
The patient will be asked to keep their mouth closed for 5 minutes after each application.
Then, insert the 5 cm applicator 2-3 cm deep into the mouth and spray ice-cold water three times sequentially onto th
|
Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, and their thirst severity and thirst-related discomfort scale will be assessed and recorded.
To prevent bronchoaspiration, the patient's bed will be raised at a 30°-45° angle.
The patient will then be instructed to open their mouth, lift their tongue, and direct the spray towards the sublingual area, the mucous membranes of both cheeks, and the surface of the tongue.
Next, a 5 cm applicator containing menthol water obtained from leaves and flowers through modern distillations and kept at +4°C will be inserted 2-3 cm deep into the mouth and sprayed three times sequentially onto the palate, the left cheek, the surface of the tongue, the right cheek, and the laryngopharynx.
Each spray will be approximately 2 ml.
Three more sprays will be administered at 2, 4, and 6 hours after arrival at the surgical clinic.
The patients' standard treatme
Cold Spray Group Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, thirst severity, and thirst-related discomfort scale.
Initial assessments (irritation, nausea, vomiting, aspiration risk, swallowing difficulty) will be performed as soon as the patient arrives at the clinic after surgery.
The patient's bed will be raised at a 30°-45° angle to prevent bronchoaspiration.
Then, the patient will be instructed to open their mouth, lift their tongue, and direct the spray towards the sublingual area, the mucous membranes of both cheeks, and the surface of the tongue.
The patient will be asked to keep their mouth closed for 5 minutes after each application.
Then, insert the 5 cm applicator into the mouth 2-3 cm deep and spray ice-cold water three times sequentially onto the palate, the left cheek, the surface of the tongue, the right cheek, and the laryngopharynx.
Each spray will be approxima
Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, and their thirst severity and thirst-related discomfort scale will be assessed.
Initial assessments (irritation, nausea, vomiting, aspiration risk, dysphagia) will be performed as soon as the patient arrives at the clinic post-surgery.
The patient's bed will be raised to a 30°-45° angle to prevent bronchoaspiration.
The patient will then be instructed to open their mouth, lift their tongue, and direct the spray towards the sublingual area, the mucous membranes of both cheeks, and the surface of the tongue.
The patient will be asked to keep their mouth closed for 5 minutes after each application.
Then, insert the 5 cm applicator 2-3 cm deep into the mouth and spray ice-cold water three times sequentially onto the palate, the left cheek, the surface of the tongue, the right cheek, and the laryngopharynx.
Each spray will be approximately
|
|
実験的：Menthol group
Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, and their thirst severity and thirst-related discomfort scale will be assessed.
Initial assessments (irritation, nausea, vomiting, aspiration risk, dysphagia) will be performed as soon as the patient arrives at the clinic post-surgery.
The patient's bed will be raised at a 30°-45° angle to prevent bronchoaspiration.
The patient will then be instructed to open their mouth, lift their tongue, and direct the spray towards the sublingual area, the mucous membranes of both cheeks, and the surface of the tongue.
The patient will be asked to keep their mouth closed for 5 minutes after each application.
Then, a 5 cm applicator will be inserted into the mouth 2-3 cm deep, and menthol water obtained from leaves and flowers through modern distillations and kept at +4°C will be sprayed three times sequentially onto the palate, the left cheek, the
|
Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, and their thirst severity and thirst-related discomfort scale will be assessed and recorded.
To prevent bronchoaspiration, the patient's bed will be raised at a 30°-45° angle.
The patient will then be instructed to open their mouth, lift their tongue, and direct the spray towards the sublingual area, the mucous membranes of both cheeks, and the surface of the tongue.
Next, a 5 cm applicator containing menthol water obtained from leaves and flowers through modern distillations and kept at +4°C will be inserted 2-3 cm deep into the mouth and sprayed three times sequentially onto the palate, the left cheek, the surface of the tongue, the right cheek, and the laryngopharynx.
Each spray will be approximately 2 ml.
Three more sprays will be administered at 2, 4, and 6 hours after arrival at the surgical clinic.
The patients' standard treatme
Cold Spray Group Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, thirst severity, and thirst-related discomfort scale.
Initial assessments (irritation, nausea, vomiting, aspiration risk, swallowing difficulty) will be performed as soon as the patient arrives at the clinic after surgery.
The patient's bed will be raised at a 30°-45° angle to prevent bronchoaspiration.
Then, the patient will be instructed to open their mouth, lift their tongue, and direct the spray towards the sublingual area, the mucous membranes of both cheeks, and the surface of the tongue.
The patient will be asked to keep their mouth closed for 5 minutes after each application.
Then, insert the 5 cm applicator into the mouth 2-3 cm deep and spray ice-cold water three times sequentially onto the palate, the left cheek, the surface of the tongue, the right cheek, and the laryngopharynx.
Each spray will be approxima
Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, and their thirst severity and thirst-related discomfort scale will be assessed.
Initial assessments (irritation, nausea, vomiting, aspiration risk, dysphagia) will be performed as soon as the patient arrives at the clinic post-surgery.
The patient's bed will be raised to a 30°-45° angle to prevent bronchoaspiration.
The patient will then be instructed to open their mouth, lift their tongue, and direct the spray towards the sublingual area, the mucous membranes of both cheeks, and the surface of the tongue.
The patient will be asked to keep their mouth closed for 5 minutes after each application.
Then, insert the 5 cm applicator 2-3 cm deep into the mouth and spray ice-cold water three times sequentially onto the palate, the left cheek, the surface of the tongue, the right cheek, and the laryngopharynx.
Each spray will be approximately
|
|
実験的：Cold Spray Group
Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, along with thirst severity and thirst-related discomfort scale.
Initial assessments (irritation, nausea, vomiting, aspiration risk, dysphagia) will be performed as soon as the patient arrives at the clinic post-surgery.
The bed will be raised to a 30°-45° angle to prevent bronchoaspiration.
The patient will then be instructed to open their mouth, lift their tongue, and direct the spray under the tongue, onto the mucous membranes of both cheeks, and onto the surface of the tongue.
The patient will be asked to keep their mouth closed for 5 minutes after each application.
Cold water will be sprayed three times, sequentially, onto the palate, the left cheek, the surface of the tongue, the right cheek, and the laryngopharynx.
Each spray will be approximately 2 ml.
Three sprays will also be administered at 2, 4, and 6 hours after arrival at
|
Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, and their thirst severity and thirst-related discomfort scale will be assessed and recorded.
To prevent bronchoaspiration, the patient's bed will be raised at a 30°-45° angle.
The patient will then be instructed to open their mouth, lift their tongue, and direct the spray towards the sublingual area, the mucous membranes of both cheeks, and the surface of the tongue.
Next, a 5 cm applicator containing menthol water obtained from leaves and flowers through modern distillations and kept at +4°C will be inserted 2-3 cm deep into the mouth and sprayed three times sequentially onto the palate, the left cheek, the surface of the tongue, the right cheek, and the laryngopharynx.
Each spray will be approximately 2 ml.
Three more sprays will be administered at 2, 4, and 6 hours after arrival at the surgical clinic.
The patients' standard treatme
Cold Spray Group Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, thirst severity, and thirst-related discomfort scale.
Initial assessments (irritation, nausea, vomiting, aspiration risk, swallowing difficulty) will be performed as soon as the patient arrives at the clinic after surgery.
The patient's bed will be raised at a 30°-45° angle to prevent bronchoaspiration.
Then, the patient will be instructed to open their mouth, lift their tongue, and direct the spray towards the sublingual area, the mucous membranes of both cheeks, and the surface of the tongue.
The patient will be asked to keep their mouth closed for 5 minutes after each application.
Then, insert the 5 cm applicator into the mouth 2-3 cm deep and spray ice-cold water three times sequentially onto the palate, the left cheek, the surface of the tongue, the right cheek, and the laryngopharynx.
Each spray will be approxima
Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, and their thirst severity and thirst-related discomfort scale will be assessed.
Initial assessments (irritation, nausea, vomiting, aspiration risk, dysphagia) will be performed as soon as the patient arrives at the clinic post-surgery.
The patient's bed will be raised to a 30°-45° angle to prevent bronchoaspiration.
The patient will then be instructed to open their mouth, lift their tongue, and direct the spray towards the sublingual area, the mucous membranes of both cheeks, and the surface of the tongue.
The patient will be asked to keep their mouth closed for 5 minutes after each application.
Then, insert the 5 cm applicator 2-3 cm deep into the mouth and spray ice-cold water three times sequentially onto the palate, the left cheek, the surface of the tongue, the right cheek, and the laryngopharynx.
Each spray will be approximately
|
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 |
|---|---|---|
|
Postoperative thirst intensity
時間枠：Baseline (upon admission to the surgical ward before intervention), and at the 2nd, 4th, and 6th postoperative hours.
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Postoperative thirst intensity will be assessed using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no thirst) to 10 (worst possible thirst).
|
Baseline (upon admission to the surgical ward before intervention), and at the 2nd, 4th, and 6th postoperative hours.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postoperative comfort
時間枠：Baseline (before intervention), and at the 2nd, 4th, and 6th postoperative hours.
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Comfort will be assessed using the Visual Analog Scale for Comfort (VAS), with higher scores indicating greater comfort.
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Baseline (before intervention), and at the 2nd, 4th, and 6th postoperative hours.
|
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出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月30日
一次修了 (推定)
2026年9月30日
研究の完了 (推定)
2026年10月30日
試験登録日
最初に提出
2026年7月22日
QC基準を満たした最初の提出物
2026年7月22日
最初の投稿 (実際)
2026年7月27日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月27日
QC基準を満たした最後の更新が送信されました
2026年7月22日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 04.05.2026
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