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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey (Türkiye)
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Experimental: Ice water spray
Other: 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
Other: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Firat University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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