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Clinical Trials/NCT07233057
NCT07233057CompletedNot Applicable

The Effect of Ice-Cold Mentholated Water Spray on Thirst Perception, Dry Mouth, Nausea, and Physiological Parameters in the Post-Rhinoplasty Period

Firat University2 sites in 1 country90 target enrollmentStarted: January 1, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
90
Locations
2
Primary Endpoint
Severity of dry mouth

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Firat University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gülcan Bahçecioğlu Turan

Principal Investigator

Firat University

Study Sites (2)

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