NCT06900621

Effects of Methods on Dry Mouth After Septoplasty Surgery

Not yet recruiting NA Last updated 3 April 2025

What this trial tests

NA trial testing ice water in Septoplasty in 81 participants. Not yet recruiting.

Timeline

25 March 2025

Primary endpoint
28 February 2026

31 December 2027

Quick facts

Lead sponsor	Ege University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	81
Start date	25 March 2025
Primary completion	28 February 2026
Estimated completion	31 December 2027
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• ice water
• room temperature water

Conditions studied

• Septoplasty — all drugs for Septoplasty →
• Dry Mouth — all drugs for Dry Mouth →

Sponsor

Ege University

Who can join

Adults 18 to 89, any sex, with Septoplasty or Dry Mouth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It was planned to investigate the effects of two different methods on early dry mouth after septoplasty surgery. The data of this study, which is planned to be conducted experimentally, is planned to be collected at Gönen State Hospital between 2025-2026. Patients who are scheduled to undergo septoplasty surgery and present with septum deviation constitute the universe of the study. The research sample (n: 63) was determined using the Power analysis G\*Power v3.1.9.7 program by taking the sample study as reference. However, considering the data losses (dropouts) in similar studies, when the missing data rate was taken as 20% , the sample size was determined as 81 patients. Patients who were informed about the study and volunteered to participate in the study (n: 81) and met the inclusion criteria of the study will constitute the sample group. 3 groups were determined in the study as intervention groups (group 1 and group 2) and control group (group 3). Patients who meet the preoperative criteria will be randomized into one of three groups after surgery. Data will be collected using the Patient Identification Form, General Patient Follow-up Form, Nasal Obstruction Symptom Assessment Scale (NOSE), Visual Analog Scale (VAS) scoring expressed by the patient to measure mouth dryness and satisfaction, "Safety Protocol for Thirst Management in the Immediate Postoperative Period" (SPTM), Oral Mucous Membrane Integrity Assessment and Follow-up Form - Oral Assessment Guide (OAG). 3 groups will be created in the study. 5 ml of ice water will be applied to one group that will receive intervention, the other group will be given water at normal room temperature, and the control group will receive standard clinical care and will not be treated. As a result of the evaluation made with SPTM in the first 30 minutes after the surgery, the dry mouth of all patients included in the study (Group 1, Group 2, Group 3) who meet the conditions will be evaluated before the application, starting from the first 30 minutes after the surgery and at 60 - 90 - 120 - 150 - 180 minutes. In the study, all patients (Group 1, Group 2, Group 3) will be evaluated for dry mouth before the application. The data obtained as a result of the study will be analyzed with a statistical package program. In the evaluation of the data in the study, descriptive statistics and parametric or non-parametric tests will be applied depending on whether the data show a normal distribution. In comparisons, p\<0.05 value will be considered statistically significant.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.