Effects of Methods on Dry Mouth After Septoplasty Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorEge University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 89
Able to communicate in Turkish
No obstacle to communication
Agreeing to participate in the study
Disqualifiers
Patients with a preoperative oral mucous membrane integrity assessment Oral Assessment Guide (OAG) result of over 16
Those taking medication that affects dry mouth
Those with a chronic disease that affects dry mouth
Those undergoing a second simultaneous surgical procedure
Trial design
Design model
Parallel
Treatments tested in this trial
ice water
Other interventionPatients 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.
room temperature water
Other interventionPatients 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.
Treatment groups
81 Participants
are divided into 3 treatment groupsGroup A: Ice Water (Group 1)Active comparator 1 intervention
Group B: Room Temperature Water (Group 2)Active comparator 1 intervention
Group C: Control (Group 3)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
dry mouth
Pre-Operative: Patients will be checked in terms of inclusion and exclusion criteria in the clinic and if they are suitable, they will be asked to participate in the study. The oral assessment guide (OAG) will be applied at this stage of the study. Patients who score 16 points or less in the OAG assessment (by the researcher using a light source and abeslang) will be included in the study. Before surgery, patients will be asked to fill out the Patient Identification Form. Then, the Nasal Obstruction Symptom Assessment Scale and the VAS scoring, expressed by the patient to measure dry mouth, will be performed and recorded in the general patient follow-up form. Post-operatively: starting from the first 30 minutes after the operation, and at 60-90-120-150-180 minutes, all patients included in the study (Group 1, Group 2, Group 3) will be evaluated for dry mouth before the application. Visual Analog Scale (VAS) will be used to determine dry mouth.
Time frame
The evaluation of dry mouth with VAS will be done once before the surgery and 6 times after the surgery and will take a total of 3-5 minutes.Secondary outcomes
1
patient satisfaction
In the literature, VAS has been used to evaluate postoperative dry mouth (Oztas and Oztas 2022; Serato et al. 2019). VAS has also been used in the assessment of satisfaction (Oztas and Oztas 2022; Lee et al. 2020; Elmashad and Gouda, 2018).
Time frame
Patient satisfaction evaluation with VAS will be done after the application is completed only for Group 1 and Group 2 after the operation. It will take a maximum of 1 minute.Sponsors and contacts
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Source ClinicalTrials.gov
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