RhinoplastyNCT07233057
The Effect of Ice Cold Mentholated Water Spray After Rhinoplasty
A study testing Menthol Cool Water Spray and Ice water spray in people with Rhinoplasty, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinoplasty
- What is being tested?
- Menthol Cool Water Spray and Ice water spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Rhinoplasty
- Being tested
- Menthol Cool Water Spray, Ice water spray
- Keywords
- Ice water spray, Mentholated cold water spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menthol Cool Water SprayOther
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).
Ice water sprayOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Ice water spray | Experimental | Not described Receives: Other: Ice water spray |
| Menthol Cool Water Spray | Experimental | Not described Receives: Other: Menthol Cool Water Spray |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of dry mouth
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).
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Jan 2025
- Primary completion1 Apr 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233057
- Sponsor's protocol ID
- 2024/11/01/4
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ice-Cold Mentholated Water Spray on Thirst Perception, Dry Mouth, Nausea, and Physiological Parameters in the Post-Rhinoplasty Period
- ClinicalTrials.gov ID
- NCT07233057
- Acronym / sponsor ID
- 2024/11/01/4
- Conditions
- Rhinoplasty
- Keywords
- Ice water spray, Mentholated cold water spray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ice water spray | Experimental | Other: Ice water spray |
| Menthol Cool Water Spray | Experimental | Other: Menthol Cool Water Spray |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menthol Cool Water SpraySterile 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). | Other | Menthol Cool Water Spray |
| Ice water spraySterile 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). | Other | Ice water spray |
Primary outcome
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).
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menthol Cool Water Spray and Ice water spray in people with Rhinoplasty, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.