Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

The Effects of Menthol and Cold Spray Applications on Thirst and Comfort in Bariatric Surgery

22. juli 2026 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

180

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: 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
Eksperimentell: 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
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative thirst intensity
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative comfort
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. juli 2026

Primær fullføring (Antatt)

30. september 2026

Studiet fullført (Antatt)

30. oktober 2026

Datoer for studieregistrering

Først innsendt

22. juli 2026

Først innsendt som oppfylte QC-kriteriene

22. juli 2026

Først lagt ut (Faktiske)

27. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 04.05.2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere