The Effects of Menthol and Cold Spray Applications on Thirst and Comfort in Bariatric Surgery
22 июля 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Оцененный)
180
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
-
Istanbul, Турция (Туркие)
- Atlas University
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Плацебо Компаратор: 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
|
|
Экспериментальный: 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
|
|
Экспериментальный: 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
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Postoperative thirst intensity
Временное ограничение: Baseline (upon admission to the surgical ward before intervention), and at the 2nd, 4th, and 6th postoperative hours.
|
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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Postoperative comfort
Временное ограничение: Baseline (before intervention), and at the 2nd, 4th, and 6th postoperative hours.
|
Comfort will be assessed using the Visual Analog Scale for Comfort (VAS), with higher scores indicating greater comfort.
|
Baseline (before intervention), and at the 2nd, 4th, and 6th postoperative hours.
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
30 июля 2026 г.
Первичное завершение (Оцененный)
30 сентября 2026 г.
Завершение исследования (Оцененный)
30 октября 2026 г.
Даты регистрации исследования
Первый отправленный
22 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
22 июля 2026 г.
Первый опубликованный (Действительный)
27 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
27 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
22 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 04.05.2026
Планирование данных отдельных участников (IPD)
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НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .