Clinical trial NCT06900621: Effects of Methods on Dry Mouth After Septoplasty Surgery
Official title: Effects of Two Different Methods on Early Period Dry Mouth After Septoplasty Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Septoplasty
Dry Mouth
Keywords: dry mouth
nursing
early period
septoplasty
water at room temperature
ice water
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was planned as an experimental, randomized controlled, single-blind study.Patients who meet the postoperative criteria will be randomized to one of three groups. Randomization was performed as a 3-way block randomization (Sealed Envelope Ltd. 2022). In the study, 3-way block randomization was applied using a blind technique. 3 participants in each block were assigned to different groups in a randomized order. The group codes determined in accordance with the randomization list were used to assign participants to the experimental conditions. This randomization method was preferred in order to provide balance between the participant groups and to minimize the potential effects of external factors.
Primary purpose: PREVENTION

Brief 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.

Detailed description: Nasal septum deviation (NSD) is one of the most common upper respiratory tract diseases causing airway obstruction, with some authors reporting a prevalence of up to 70-80% in the general population. In NSD, breathing through the mouth instead of the nose may cause complaints of dry mouth and sore throat. In addition to NSD, diseases and medications that cause dry mouth include the presence of an endotracheal tube in intensive care patients, the presence of an orogastric or nasogastric tube, frequent oral aspiration, therapeutic dehydration (e.g. cardiogenic shock or ARDS), not taking fluids or nutrients by mouth, fever, diarrhea, burns, continuous oxygen therapy, dysphagia, fear, and anxiety. Klavuz et al. (2022) found that gender did not have much of an effect on dry mouth and the prevalence of dry mouth could be seen at different rates as a result of their study conducted between the ages of 16-90. In addition, it was observed that smoking reduced the salivary flow rate; however, it was not the primary factor causing hyposalivation. Although septoplasty is the most commonly performed surgery in NSD, the severity, side and type of nasal obstruction should be taken into consideration when making the surgical decision. Özkiriş and Mutlu (2010) stated that NSD was determined in 39% of 20,596 patients and only 2,113 of the patients had complaints of nasal obstruction and surgery was applied to approximately 55% of them. The terms dry mouth and thirst, which are often used interchangeably, are the most common symptoms of terminal dehydration, along with nausea, vomiting and fatigue. The patient's feeling of dry mouth is defined as a distressing discomfort. Preoperative fasting, medication use during anesthesia-surgery, mechanical ventilation with an endotracheal tube, application of devices such as airway, blood loss during surgery, etc. may present situations that encourage and increase the appearance of thirst, and may also cause deterioration of oral health, salivary flow rate and content in patients. Moon et al. (2015) compared cold water and cold saline gauze in their study and concluded that wet gauze can be applied with cold normal saline to reduce thirst and salivary acidity and improve the condition of the oral cavity in patients after surgery. Thirst and dry mouth increase as decreased salivary flow decreases the pH of saliva. The risk of dry mouth is defined as sensitivity to discomfort or damage in the oral mucosa due to decreased quantity or quality of saliva, while mouth breathing is among the risk factors for the diagnosis of oral mucous membrane deterioration. In the literature, it is stated that sipping a small amount of water is the most common and practical method in the treatment of dry mouth; in addition, mouthwashes, moisturizing products and artificial saliva products are effective in improving the quality of life and maintaining and protecting oral health. Many different methods have been used for the intervention of postoperative dry mouth before and after surgery. Garcia (2019) reported that in the preoperative application of mentholated chewing gum, dry mouth increased from 64.7 to 72.5 in the control group and decreased from 64.7 to 3.9 in the intervention group. In a similar study, dry mouth also decreased. In bariatric surgery patients in the PACU with videolaparoscopy, the use of a mentholated pack was not more effective than a non-mentholated precaution pack in terms of reducing thirst intensity, improving lip hydration, dryness and oral cavity taste for one hour, and the mentholated strategy was proven to be effective after a single application. In a similar study, it was found that a mentholated care pack only improved the tongue and saliva in postoperative patients undergoing abdominal surgery. In the study of Oztas and Oztas (2022), no significant difference was found between the three groups in terms of age, gender, ASA, preoperative thirst and dry mouth, and preoperative oral health status. A significant difference was found between the groups after 8, 20, 24, 36, and 40 hours in terms of thirst and dry mouth severity scores. The intervention group receiving cold water spray showed statistically significant differences when compared with the control groups receiving cold saline and 1-2 ml room temperature water, but no significant difference was found between the oral health status and pH scores after 4, 8, 20, 24, 36, and 40 hours. It shows that cold water spray is more effective on the thirst and dry mouth scores of patients undergoing major abdominal surgery compared to cold normal saline spray and water applied using a syringe, but it is not an effective factor on oral health status and saliva pH values. Hur et al. (2009) examined the effects of gargling with cold water, applying wet gauze and moisturizing after nasal surgery; a significant decrease in mouth dryness was found in the intervention group at 2-4 hours, and a significant decrease in mouth dryness was found in the control group at 4 hours. As a result, gargling with cold water was found to be an effective nursing intervention to reduce postoperative thirst and dry mouth, and gargling with cold water was found to be effective in reducing thirst in relation to the duration. Gu et al. (2022) compared wiping with cold water gauze and not wiping with cold water gauze in patients undergoing nasal surgery, and concluded that there was no significant difference between the two groups in terms of thirst and oral status after the intervention, but thirst and oral status improved significantly. However, no study has been found that evaluates the effects of ice water and room temperature water interventions on dry mouth after septoplasty surgery. The subject of this thesis is to examine the effects of interventions on dry mouth in patients after septoplasty. The aim of this study is to investigate the effects of two different methods on early period dry mouth after septoplasty surgery.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 89
* Able to communicate in Turkish
* No obstacle to communication
* Agreeing to participate in the study
* Conscious and oriented as a result of the evaluation made with SPMT at 30 minutes after the surgery, with a clear airway, no nausea or vomiting
* Using silicone nasal tampons

Exclusion Criteria:

* 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
* Those who develop complications during surgery and/or during recovery from anesthesia
* Patients who smoke will not be included in the study.

Primary outcomes:
measure: dry mouth
timeFrame: 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:
measure: patient satisfaction
timeFrame: 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.
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Gönen State Hospital
state: Gönen
Study officials:
affiliation: Ege University
name: Eda Dolgun, Ass. Prof.
role: STUDY_DIRECTOR
References: