The Effects of Menthol and Cold Spray Applications on Thirst and Comfort in Bariatric Surgery
22 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
180
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Istanbul, Turcja (Türkiye)
- Atlas University
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Komparator placebo: 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
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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
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Eksperymentalny: 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
|
|
Eksperymentalny: 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
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Postoperative thirst intensity
Ramy czasowe: 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).
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Baseline (upon admission to the surgical ward before intervention), and at the 2nd, 4th, and 6th postoperative hours.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Postoperative comfort
Ramy czasowe: 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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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
30 lipca 2026
Zakończenie podstawowe (Szacowany)
30 września 2026
Ukończenie studiów (Szacowany)
30 października 2026
Daty rejestracji na studia
Pierwszy przesłany
22 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
22 lipca 2026
Pierwszy wysłany (Rzeczywisty)
27 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
27 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
22 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 04.05.2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .