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Not yet recruitingNCT07728500Updated Jul 27, 2026

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

An interventional study of Menthol Group and Cold Spray Group in Thirst in Bariatric Surgery Patients, sponsored by Atlas University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Atlas University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Thirst in Bariatric Surgery Patients
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In context

Lead sponsor

Atlas University is the lead sponsor of 96 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Placebo comparator
    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

    Other: Menthol Group · Other: Cold Spray Group · Other: Placebo Group

  • 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

    Other: Menthol Group · Other: Cold Spray Group · Other: Placebo Group

  • 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

    Other: Menthol Group · Other: Cold Spray Group · Other: Placebo Group

Interventions

  • OtherMenthol 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 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

  • OtherCold Spray Group

    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

  • OtherPlacebo 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 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

06

What researchers measure

Primary outcomes

  1. Postoperative thirst intensity

    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).

    Time frame: Baseline (upon admission to the surgical ward before intervention), and at the 2nd, 4th, and 6th postoperative hours.

Secondary outcomes

  1. Postoperative comfort

    Comfort will be assessed using the Visual Analog Scale for Comfort (VAS), with higher scores indicating greater comfort.

    Time frame: Baseline (before intervention), and at the 2nd, 4th, and 6th postoperative hours.

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Study locations

1 site
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References and documents

Publications

  • Lian R, Zhou S, Guo Y, Liang H, Lin J, Li D, Wu W, Rao Y, Shao D, Zheng P, Yang X. The effect of ice-cold water spray following the model for symptom management on postoperative thirst in patients admitted to intensive care unit: A randomized controlled study. Intensive Crit Care Nurs. 2024 Apr;81:103571. doi: 10.1016/j.iccn.2023.103571. Epub 2024 Jan 10. PubMed 38211420 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07728500
Lead sponsor
Atlas University
Responsible party
Cagla Toprak (Dr., Atlas University) — Principal investigator
First posted
Jul 27, 2026
Start date
Jul 30, 2026 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Jul 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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