- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07233057
The Effect of Ice Cold Mentholated Water Spray After Rhinoplasty
November 14, 2025 updated by: Gülcan Bahçecioğlu Turan, Firat University
The Effect of Ice-Cold Mentholated Water Spray on Thirst Perception, Dry Mouth, Nausea, and Physiological Parameters in the Post-Rhinoplasty Period
This clinical trial aims to evaluate the effects of a menthol-infused cold water spray on thirst perception, dry mouth, nausea, and physiological parameters in patients after rhinoplasty.
The intervention is expected to provide a refreshing sensation, alleviate discomfort associated with postoperative thirst and dryness, and contribute to improved patient comfort and recovery.
Physiological parameters such as heart rate, blood pressure, and oxygen saturation will also be monitored to assess systemic effects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Center
-
Elâzığ, Center, Turkey (Türkiye), 25240
- Fırat university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Must be extubated in the surgical intensive care unit after surgery for at least 3 hours or more
- Must be 18 years of age or older
- Must be conscious and oriented to time and place
- Must be ASA class I-III and Mallampati class I-II, must have a Mann assessment of swallowing ability score of ≥95, and must have a Glasgow Coma Scale (GCS) score of 15
- Must have given informed consent to participate in the study
Exclusion Criteria Patients were excluded from the study if they had: • Ingestion or absolute contraindications to swallowing any substance,
- Mandibular trauma,
- Patients undergoing ear, nose, and throat, intracranial, or oral surgery,
- Patients allergic to menthol or those who do not prefer menthol water,
- Patients with compromised oral and lingual mucosal integrity before surgery,
- Patients with any neurological, renal, cardiac, or pulmonary disease,
- Patients taking psychoactive medications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Ice water spray
|
Sterile ice water, cooled to 0-6°C in the refrigerator, will be stored in glass bottles with oral spray heads.
The first application will be made half an hour after extubation, and then every hour for the next three hours.
The spray will be applied to different areas of the patient's mouth (upper jaw, lower jaw, left cheek, right cheek, and tongue).
|
|
Experimental: Menthol Cool Water Spray
|
Sterile ice water with menthol, cooled between 0-6°C in the refrigerator, will be stored in glass bottles with oral spray heads.
The first application will be made half an hour after extubation, and then every hour for the next three hours.
The spray will be applied to different areas of the patient's mouth (upper jaw, lower jaw, left cheek, right cheek, and tongue).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of dry mouth
Time Frame: The samples were evaluated at 4 time points: immediately before the first application (To) and 30 minutes after each of the three applications (T1, T2, T3).
|
Severity of dry mouth The severity of dry mouth was assessed using a VAS with a score between 0 and 10 (0 = I do not experience dry mouth at all, 10 = I experience very severe dry mouth).
|
The samples were evaluated at 4 time points: immediately before the first application (To) and 30 minutes after each of the three applications (T1, T2, T3).
|
|
Nausea Severity
Time Frame: The samples were evaluated at 4 time points: immediately before the first application (To) and 30 minutes after each of the three applications (T1, T2, T3).
|
Nausea is assessed in the same way using the Vas.
Nausea is assessed by labeling one end of the scale as "no nausea" and the other as "very severe nausea" and asking the patient to place a mark on the scale indicating the severity of nausea.
The distance (in cm) from the "no nausea" end of the scale to the mark made by the patient is used to measure the patient's nausea.
|
The samples were evaluated at 4 time points: immediately before the first application (To) and 30 minutes after each of the three applications (T1, T2, T3).
|
|
372 / 5.000 Thirst Severity
Time Frame: The samples were evaluated at 4 time points: immediately before the first application (To) and 30 minutes after each of the three applications (T1, T2, T3).
|
A Visual Analog Scale (VAS) was used to assess the subjects' thirst severity, with a score ranging from 0 to 10 (0 = not at all, 10 = very severe).
|
The samples were evaluated at 4 time points: immediately before the first application (To) and 30 minutes after each of the three applications (T1, T2, T3).
|
|
Physiological Parameters Tracking Form
Time Frame: The samples were evaluated at 4 time points: immediately before the first application (To) and 30 minutes after each of the three applications (T1, T2, T3).
|
This form was also developed by the researchers and included heart rate, systolic and diastolic blood pressures, and oxygen saturation levels.
Participants' physiological parameters were recorded a total of four times in both groups: once at baseline and then 30 minutes after each exercise.
|
The samples were evaluated at 4 time points: immediately before the first application (To) and 30 minutes after each of the three applications (T1, T2, T3).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2025
Primary Completion (Actual)
April 1, 2025
Study Completion (Actual)
August 1, 2025
Study Registration Dates
First Submitted
November 14, 2025
First Submitted That Met QC Criteria
November 14, 2025
First Posted (Actual)
November 18, 2025
Study Record Updates
Last Update Posted (Actual)
November 18, 2025
Last Update Submitted That Met QC Criteria
November 14, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2024/11/01/4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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