Effects of Methods on Dry Mouth After Septoplasty Surgery

NCT06900621 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-04-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

ice water

Patients who apply SPTM are given a semifowler position with the head of the bed at least 45°, if there is no contraindication. The water temperature (5-9 °C) will be measured with a calibrated digital thermometer. After VAS scoring, patients are sprayed with 5 ml of ice water placed in spray cans every 30 minutes until all the water is used up in the mouth, tongue, palate, floor of the mouth, inside the right and left cheeks, depending on the group. A total of 5 rounds are made with 5 ml of water in one round (0.2 ml is sprayed on the tongue, palate, floor of the mouth, inside the right and left cheeks) and each round is planned to be completed in 1 minute and last at most 5 minutes. This application is applied to the intervention groups 5 times in total (30th min- 60th min- 90th min- 120th min- 150th min). The first oral intake of the patients is routinely started at the 180th minute.

OTHER

room temperature water

Patients who apply SPTM are given a semifowler position with the head of the bed at least 45°, if there is no contraindication. The water temperature (15-24 °C) will be measured with a calibrated digital thermometer. After VAS scoring, patients are sprayed with 5 ml of room temperature water placed in spray cans every 30 minutes until all the water is used up in the mouth, tongue, palate, floor of the mouth, inside the right and left cheeks, depending on the group. A total of 5 rounds are made with 5 ml of water in one round (0.2 ml is sprayed on the tongue, palate, floor of the mouth, inside the right and left cheeks) and each round is planned to be completed in 1 minute and last at most 5 minutes. This application is applied to the intervention groups 5 times in total (30th min- 60th min- 90th min- 120th min- 150th min). The first oral intake of the patients is routinely started at the 180th minute.

Sponsors & Collaborators

  • Ege University

    lead OTHER

Principal Investigators

  • Eda Dolgun, Ass. Prof. · Ege University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2026-02-28
Completion
2027-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06900621 on ClinicalTrials.gov