The Effects of Menthol and Cold Spray Applications on Thirst and Comfort in Bariatric Surgery
22 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
180
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Atlas University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: 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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Experimental: 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
|
|
Experimental: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative thirst intensity
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative comfort
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de julio de 2026
Finalización primaria (Estimado)
30 de septiembre de 2026
Finalización del estudio (Estimado)
30 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
22 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de julio de 2026
Publicado por primera vez (Actual)
27 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 04.05.2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .